Atopic DermatitisNCT04950374

A Clinical Trial to Evaluate the Safety and Efficacy of a Moisturizer Body Lotion and a Lip Moisturizer in Adults of Atopic Dermatitis.

A study testing Moisturizer Body Lotion and Lip Moisturizer in people with Atopic Dermatitis, run by Johnson & Johnson Consumer Inc. (J&JCI).

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

Who is it for?: Ages 18 to 59 years
Conditions the study is for: Atopic Dermatitis
What is being tested?: Moisturizer Body Lotion and Lip Moisturizer
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: No sites listed yet
Study dates: 26 Jul 2021to 10 Dec 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 59 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Fitzpatrick Skin Type I to VI;
Subjects with mild to moderate atopic dermatitis according to the SCORAD index (mild global score (up to 24) and moderate global score (between 25 to 50), presenting dermatological lesions at the initial study visit;
Generally in good health based on medical history reported by the subject;
Able to read, write, speak and understand Portuguese;
Person who signed the Consent for Photograph Release and Informed Consent Form;
Person who agrees to change their leave on body and lip moisturizers to the products of this study, and agrees to use them throughout the test period;
Intends to complete the study and is willing and able to follow all study instructions.

Who cannot join

Subject who attends the Study Site, on the inclusion visit, with leave on moisturizer applied on the instrumental and microbiome evaluation areas;
Present the need for systemic treatments (as in severe atopic dermatitis cases) such as the use of oral corticosteroids or other types of systemic treatments, as assessed by the Study Physician;
Perform topical antimicrobial therapies (such as sodium hypochlorite bath or use of topical antibiotics);
Perform phototherapy;
Use of antimicrobial / antibacterial / anti germ soaps or other cosmetic and hygiene products;
Subject who has used other leave on moisturizers in the test areas (body, face and lip), with the exception of investigational products, and/or who has changed their hygiene products during the study;

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Has known allergies or adverse reactions to common topical skincare products;
Present a skin condition that may influence the outcome of the study (e.g., psoriasis, active skin cancer, etc);
Present skin lesions (e.g., ulcers, vesicles) or tattoos in the test areas, with the exception of lesions associated with mild or moderate atopic dermatitis;
Has self-reported Type 1 or Type 2 diabetes or is taking insulin or another anti-diabetic medication;
Is taking a medication that would mask an Adverse Event (AE) or confound the study results, including:
Immunosuppressive drugs within 2 months before Visit 1; Immunobiological drugs within 2 months before visit 1; Topical anti-inflammatory steroids (corticosteroids) within 15 days before the visit 1; Topical and systemic immunomodulators (such as Tacrolimus and Pimecrolimus) within 15 days before visit 1; Topical and systemic antibiotics 15 days before the visit 1; Non-steroidal anti-inflammatory drugs within 15 days before Visit 1 ; Antihistamines within 2 weeks before Visit 1;
Is self-reported to be pregnant or planning to become pregnant during the study;
Has a history of or a concurrent health/other condition/situation which may put the individual at significant risk, confound the study results, or interfere significantly with the individual's participation in the study;
Participating simultaneously in another study;
Is an employee/contractor or immediate family member of the PI, Study Site, or Sponsor;
History of a confirmed Coronavirus disease (COVID-19) in the past 30 days;
Contact with a person infected with COVID-19 within 14 days prior to inclusion;
Any international travel within 14 days of inclusion, including members of the same family;
Subjects with self-reported symptoms in the past 2 weeks: unexplained cough, shortness of breath / difficulty breathing, fatigue, body aches (headaches, muscle aches, stomach pains), conjunctivitis, loss of smell, loss of taste, lack of appetite, nausea, vomiting, diarrhea, palpitations, fever or pain / tightness in the chest; temperature ≥ 38.0 degrees Celsius/100.4 degrees Fahrenheit measured; use of fever reducers within the last 2 days of each onsite visit.

About this study

Official title: Single Center, Open-label, Non-randomized Clinical Trial to Evaluate the Safety and Efficacy of a Moisturizer Body Lotion and the Safety and Perceived Efficacy of a Lip Moisturizer in Adults With Atopic Dermatitis Presenting Dermatological Lesion.

This study will test the safety and efficacy of 2 moisturizers: a body lotion and a lip moisturizer. For the moisturizer body lotion, the study aims to determine the tolerance of this product by the study population, and its effects on atopic dermatitis condition, skin hydration, skin barrier, skin microbiome and perceived efficacy. For the lip moisturizer, the study aims to determine the tolerance of this product by the same study population and its effects on the perceived efficacy. Participants will receive both products and use them at home for 21 +/- 2 days.

Conditions: Atopic Dermatitis
Being tested: Moisturizer Body Lotion, Lip Moisturizer
Medical subject headings: Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Moisturizer Body LotionOther
The body lotion product is a moisturizing formulation intended for topical use on the whole body and face. It will be applied at least twice daily.
Lip MoisturizerOther
The lip product is a moisturizing formulation intended for topical use on the lips. It will be applied at least twice daily.

Study groups in NCT04950374
Study group	Role	What they receive
Moisturizer Body Lotion and Lip Moisturizer Regimen	Experimental	All participants will receive and use both products. Receives: Other: Moisturizer Body Lotion; Other: Lip Moisturizer

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from baseline of scores of erythema to 21 ± 2 days
At baseline and at 21 ± 2 days, the study physician will evaluate the whole body (including face) and the lips and score the identified erythemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify this skin reaction on the whole body (including face), and on the lips. The change from baseline will be evaluated to assess skin tolerance of both study products.
Measured: 21 ± 2 days
Change from baseline of the scores of peeling to 21 ± 2 days
At baseline and at 21 ± 2 days, the study physician will evaluate the whole body (including face) and the lips and score the identified peeling according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify this skin reaction on the whole body (including face), and on the lips. The change from baseline will be evaluated to assess skin tolerance of both study products.
Measured: 21 ± 2 days
Change from baseline of the scores of blistering to 21 ± 2 days
At baseline and at 21 ± 2 days, the study physician will evaluate the whole body (including face) and the lips and score the identified blistering according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify this skin reaction on the whole body (including face), and on the lips. The change from baseline will be evaluated to assess skin tolerance of both study products.
Measured: 21 ± 2 days
Change from baseline of the scores to edema to 21 ± 2 days
At baseline and at 21 ± 2 days, the study physician will evaluate the whole body (including face) and the lips and score the identified edema according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify this skin reaction on the whole body (including face), and on the lips. The change from baseline will be evaluated to assess skin tolerance of both study products.
Measured: 21 ± 2 days
Percentage of participants with Adverse Events through 21 ± 2 days
The percentage of participants with AEs, serious adverse events (SAEs), AEs leading to discontinuation and AEs related to skin reactions will be evaluated for skin tolerance up to 21 ± 2 days.
Measured: Up to 21 ± 2 days
Change from baseline of scores of erythema to 5 ± 1 days
At baseline and at 5 ± 1 days, the study physician will evaluate the whole body (including face) and the lips and score the identified erythemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify this skin reaction on the whole body (including face), and on the lips. The change from baseline will be evaluated to assess skin tolerance of both study products.
Measured: 5 ± 1 days
Change from baseline of the scores of peeling to 5 ± 1 days
At baseline and at 5 ± 1 days, the study physician will evaluate the whole body (including face) and the lips and score the identified peeling according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify this skin reaction on the whole body (including face), and on the lips. The change from baseline will be evaluated to assess skin tolerance of both study products.
Measured: 5 ± 1 days
Change from baseline of the scores of blistering to 5 ± 1 days
At baseline and at 5 ± 1 days, the study physician will evaluate the whole body (including face) and the lips and score the identified blistering according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify this skin reaction on the whole body (including face), and on the lips. The change from baseline will be evaluated to assess skin tolerance of both study products.
Measured: 5 ± 1 days
Change from baseline of the scores of edema to 5 ± 1 days
At baseline and at 5 ± 1 days, the study physician will evaluate the whole body (including face) and the lips and score the identified edema according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify this skin reaction on the whole body (including face), and on the lips. The change from baseline will be evaluated to assess skin tolerance of both study products.
Measured: 5 ± 1 days

Secondary outcomes (27)

Change from baseline of Atopic Dermatitis severity based on Scoring Atopic Dermatitis Index (SCORAD) to 21 ± 2 days
Atopic dermatitis (AD) severity based on SCORAD Index will be reported at baseline and 21 ± 2 days. The tool involves not only medical assessment, but also subjective symptom assessments reported by the subject. The index is divided into the following parts, which receives a numerical score: Extension (ares with AD lesions); Intensity of reactions (erythema, edema, exudation/crusts, abrasions, lichenification and dry skin; and Subjective Symptoms (pruritus and sleep loss). To evaluate these parameters, a scale from 0 to 10 is used. At the end, a global classification of AD is automatically attributed to each subject. Lower global scores means that less severe is the AD condition.
This assessment will be used to determine the effect of the moisturizer body lotion on AD condition of the study population after a period of use.
Measured: 21 ± 2 days
Change from baseline to 5 ± 1 days of Atopic Dermatitis severity based on Scoring Atopic Dermatitis Index (SCORAD)
Atopic dermatitis (AD) severity based on SCORAD Index will be reported at baseline and 5 ± 1 days. The tool involves not only medical assessment, but also subjective symptom assessments reported by the subject. The index is divided into the following parts, which receives a numerical score: Extension (ares with AD lesions); Intensity of reactions (erythema, edema, exudation/crusts, abrasions, lichenification and dry skin; and Subjective Symptoms (pruritus and sleep loss). To evaluate these parameters, a scale from 0 to 10 is used. At the end, a global classification of AD is automatically attributed to each subject. Lower global scores means that less severe is the AD condition.
This assessment will be used to determine the effect of the moisturizer body lotion on AD condition of the study population after a period of use.
Measured: 5 ± 1 days
Change from 5 ± 1 days of Atopic Dermatitis severity based on Scoring Atopic Dermatitis Index (SCORAD) to 21 ± 2 days
Atopic dermatitis (AD) severity based on SCORAD Index will be reported at 5 ± 1 days and 21 ± 2 days. The tool involves not only medical assessment, but also subjective symptom assessments reported by the subject. The index is divided into the following parts, which receives a numerical score: Extension (ares with AD lesions); Intensity of reactions (erythema, edema, exudation/crusts, abrasions, lichenification and dry skin; and Subjective Symptoms (pruritus and sleep loss). To evaluate these parameters, a scale from 0 to 10 is used. At the end, a global classification of AD is automatically attributed to each subject. Lower global scores means that less severe is the AD condition.
This assessment will be used to determine the effect of the moisturizer body lotion on AD condition of the study population after a period of use.
Measured: 5 ± 1 days to 21 ± 2 days
Mean change from baseline to 21 ± 2 days in skin hydration level of areas with and without AD lesions
Skin hydration level of areas with and without AD lesions will be measured with corneometer, a recognized device that determine the water content of stratum corneum. This measure will be used to determine the effect of the moisturizer body lotion on skin hydration of the study population after a period of use.
Measured: 21 ± 2 days
Mean change from baseline to 5 ± 1 days in skin hydration level of areas with and without AD lesions
Skin hydration level of areas with and without AD lesions will be measured with corneometer, a recognized device that determine the water content of stratum corneum. This measure will be used to determine the effect of the moisturizer body lotion on skin hydration of the study population after a period of use.
Measured: 5 ± 1 days
Mean change from 5 ± 1 days to 21 ± 2 days in skin hydration level of areas with and without AD lesions
Skin hydration level of areas with and without AD lesions will be measured with corneometer, a recognized device that determine the water content of stratum corneum. This measure will be used to determine the effect of the moisturizer body lotion on skin hydration of the study population after a period of use.
Measured: 5 ± 1 days to 21 ± 2 days
Mean change from baseline to 21 ± 2 days in transepidermal water loss (TEWL) to assess skin barrier integrity of areas with and without AD lesions
Skin barrier integrity of areas with and without AD lesions will be evaluated using a recognized device that determine the transepidermal water loss. Lower levels of TEWL may be related to a more integrate skin barrier. This measure will be used to determine the effect of the moisturizer body lotion on skin barrier of the study population after a period of use.
Measured: 21 ± 2 days
Mean change from baseline to 5 ± 1 days in transepidermal water loss (TEWL) to assess skin barrier integrity of areas with and without AD lesions
Skin barrier integrity of areas with and without AD lesions will be evaluated using a recognized device that determine the transepidermal water loss. Lower levels of TEWL may be related to a more integrate skin barrier. This measure will be used to determine the effect of the moisturizer body lotion on skin barrier of the study population after a period of use.
Measured: 5 ± 1 days
Mean change from 5 ± 1 days to 21 ± 2 days in transepidermal water loss (TEWL) to assess skin barrier integrity of areas with and without AD lesions
Skin barrier integrity of areas with and without AD lesions will be evaluated using a recognized device that determine the transepidermal water loss. Lower levels of TEWL may be related to a more integrate skin barrier. This measure will be used to determine the effect of the moisturizer body lotion on skin barrier of the study population after a period of use.
Measured: 5 ± 1 days to 21 ± 2 days
Mean change from baseline to 21 ± 2 days in the Patient-Oriented Eczema Measure (POEM) total score to assess AD severity
The POEM is a simple, valid, easily interpreted, and reproducible tool for assessing AD and monitoring aspects of the disease that are important to participants with AD. This tool consists in a questionnaire responded by the participants with questions related to seven AD symptoms (itchy skin, sleep disturbance, bleeding skin, skin weeping/oozing, skin flaking, skin cracking, skin dryness/roughness). Participants must respond each questions specifying how many times per week the symptoms occur using the options: none day; 1 to 2 days; 3 to 4 days; 5 to 6 days; every day. Then each response receives the one of the following scores:
0 = no days;
1= 1-2 days; 2 = 3-4 days; 3 = 5-6 days 4= every day. In the end, a total score is calculated by the sum of the 7 items (rating from 0 to 28). Higher scores correlates to a more severe AD condition.
This measure will be used to determine the effect of the moisturizer body lotion on AD condition of the study population after a period of use.
Measured: 21 ± 2 days
Mean change from baseline to 7 days in the Patient-Oriented Eczema Measure (POEM) total score to assess AD severity
The POEM is a simple, valid, easily interpreted, and reproducible tool for assessing AD and monitoring aspects of the disease that are important to participants with AD. This tool consists in a questionnaire responded by the participants with questions related to seven AD symptoms (itchy skin, sleep disturbance, bleeding skin, skin weeping/oozing, skin flaking, skin cracking, skin dryness/roughness). Participants must respond each questions specifying how many times per week the symptoms occur using the options: none day; 1 to 2 days; 3 to 4 days; 5 to 6 days; every day. Then each response receives the one of the following scores:
0 = no days;
1= 1-2 days; 2 = 3-4 days; 3 = 5-6 days 4= every day. In the end, a total score is calculated by the sum of the 7 items (rating from 0 to 28). Higher scores correlates to a more severe AD condition.
This measure will be used to determine the effect of the moisturizer body lotion on AD condition of the study population after a period of use.
Measured: 7 days
Mean change from baseline to 14 days in the Patient-Oriented Eczema Measure (POEM) total score to assess AD severity
The POEM is a simple, valid, easily interpreted, and reproducible tool for assessing AD and monitoring aspects of the disease that are important to participants with AD. This tool consists in a questionnaire responded by the participants with questions related to seven AD symptoms (itchy skin, sleep disturbance, bleeding skin, skin weeping/oozing, skin flaking, skin cracking, skin dryness/roughness). Participants must respond each questions specifying how many times per week the symptoms occur using the options: none day; 1 to 2 days; 3 to 4 days; 5 to 6 days; every day. Then each response receives the one of the following scores:
0 = no days;
1= 1-2 days; 2 = 3-4 days; 3 = 5-6 days 4= every day. In the end, a total score is calculated by the sum of the 7 items (rating from 0 to 28). Higher scores correlates to a more severe AD condition.
This measure will be used to determine the effect of the moisturizer body lotion on AD condition of the study population after a period of use.
Measured: 14 days
Perceived Efficacy of the quality of life at baseline
Perceived efficacy related to the quality of life will be subjectively evaluated by the participants through a questionnaire with questions related to the impact of AD in the quality of life. Participants will answer each question using the following qualitative scale: Affected very much; moderately affected; affected a little; did not affected.
This questionnaire will be used to evaluate the impact of AD in the quality of life before investigational product "Moisturizer body lotion" is used. The responses for each questions will be provided as percentages.
Measured: Baseline
Perceived Efficacy in the quality of life at 7 days
Perceived efficacy related to the quality of life will be subjectively evaluated by the participants through a questionnaire with questions related to the improvement in the quality of life after 7 days of moisturizer body lotion usage. Participants will answer each question using the following qualitative scale: Helped very much; moderately helped; helped a little; did not helped.
This questionnaire will be used to evaluate the impact of the moisturizer body lotion in the quality of life after periods of use of this product. The responses for each questions will be provided as percentages.
Measured: 7 days
Perceived Efficacy in the quality of life at 14 days
Perceived efficacy related to the quality of life will be subjectively evaluated by the participants through a questionnaire with questions related to the improvement in the quality of life after 14 days of moisturizer body lotion usage. Participants will answer each question using the following qualitative scale: Helped very much; moderately helped; helped a little; did not helped.
This questionnaire will be used to evaluate the impact of the moisturizer body lotion in the quality of life after periods of use of this product. The responses for each questions will be provided as percentages.
Measured: 14 days
Perceived Efficacy in the quality of life at 21 ± 2 days
Perceived efficacy related to the quality of life will be subjectively evaluated by the participants through a questionnaire with questions related to the improvement in the quality of life after 21 ± 2 days of moisturizer body lotion usage. Participants will answer each question using the following qualitative scale: Helped very much; moderately helped; helped a little; did not helped.
This questionnaire will be used to evaluate the impact of the moisturizer body lotion in the quality of life after periods of use of this product.The responses for each questions will be provided as percentages.
Measured: 21 ± 2 days
Perceived Efficacy of the moisturizer body lotion at 7 days
Perceived efficacy related to the attributes of moisturizer body lotions will be subjectively evaluated by the participants through a questionnaire using the following qualitative scale: totally agree; agree; neither agree, nor disagree; disagree.
The responses for each questions will be provided as percentages.
Measured: 7 days
Perceived Efficacy of the moisturizer body lotion at 14 days
Perceived efficacy related to the attributes of moisturizer body lotions will be subjectively evaluated by the participants through a questionnaire using the following qualitative scale: totally agree; agree; neither agree, nor disagree; disagree.
The responses for each questions will be provided as percentages.
Measured: 14 days
Perceived Efficacy of the moisturizer body lotion at 21 ± 2 days
Perceived efficacy related to the attributes of moisturizer body lotions will be subjectively evaluated by the participants through a questionnaire using the following qualitative scale: totally agree; agree; neither agree, nor disagree; disagree.
The responses for each questions will be provided as percentages.
Measured: 21 ± 2 days
Perceived Efficacy of the lip moisturizer at 7 days
Perceived efficacy related to the attributes of the lip moisturizer will be subjectively evaluated by the participants through a questionnaire using the following qualitative scale: totally agree; agree; neither agree, nor disagree; disagree. The answer option "Not applicable" can be used.
The responses for each questions will be provided as percentages.
Measured: 7 days
Perceived Efficacy of the lip moisturizer at 21 ± 2 days
Perceived efficacy related to the attributes of the lip moisturizer will be subjectively evaluated by the participants through a questionnaire using the following qualitative scale: totally agree; agree; neither agree, nor disagree; disagree. The answer option "Not applicable" can be used.
The responses for each questions will be provided as percentages.
Measured: 21 ± 2 days
Determination of types and quantity of bacteria (skin microbiome) of areas with and without AD lesions at baseline
Skin microbiome is a group of microorganisms, including bacteria, present on the skin surface and plays an important role in AD. To evaluate the type and number of bacteria present on the surface of areas with and without AD lesions, a sample will be collected on this areas using a swab. The evaluation will be done through metagenomics, a technique that allows the determination of the types and quantity of bacteria present in an specific area.
This assessment will be used to determine the effect of the moisturizer body lotion on skin microbiome after a period of use.
Measured: Baseline
Determination of types and quantity of bacteria (skin microbiome) of areas with and without AD lesions at 21 ± 2 days
Skin microbiome is a group of microorganisms, including bacteria, present on the skin surface and plays an important role in AD. To evaluate the type and number of bacteria present on the surface of areas with and without AD lesions, a sample will be collected on this areas using a swab. The evaluation will be done through metagenomics, a technique that allows the determination of the types and quantity of bacteria present in an specific area.
This assessment will be used to determine the effect of the moisturizer body lotion on skin microbiome after a period of use.
Measured: 21 ± 2 days
Visual skin condition of areas with and without AD lesions at baseline captured photographically
Images of areas with and without AD lesions will be captured through a professional camera at baseline to visualize the skin condition of these areas before the use of moisturizer body lotion.
No analysis is planned. These images will be used as a qualitative complement to the other results for moisturizer body lotion.
Measured: Baseline
Visual skin condition of areas with and without AD lesions at 5 ± 1 days captured photographically
Images of areas with and without AD lesions will be captured through a professional camera at 5 ± 1 days to visualize the skin condition of these areas after the use of moisturizer body lotion.
No analysis is planned. These images will be used as a qualitative complement to the other results for moisturizer body lotion.
Measured: 5 ± 1 days
Visual skin condition of areas with and without AD lesions at 21 ± 2 days captured photographically
Images of areas with and without AD lesions will be captured through a professional camera at 21 ± 2 days to visualize the skin condition of these areas after the use of moisturizer body lotion.
No analysis is planned. These images will be used as a qualitative complement to the other results for moisturizer body lotion.
Measured: 21 ± 2 days
Testimonial regarding the experience with moisturizer body lotion at 21 ± 2 days
A testimonial regarding the experience with moisturizer body lotion will be provided by the participants through an open question at the end of the study. The purpose is to know their opinion and experience using this product during the study.
Measured: 21 ± 2 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Jul 202110 Dec 2021

First posted6 Jul 2021
Study start26 Jul 2021 (estimated)
Primary completion26 Nov 2021 (estimated)
Study completion10 Dec 2021 (estimated)

Why it stopped: Study halted prematurely, prior to enrollment of first participant due to change on study design.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Atopic DermatitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04950374
Sponsor's protocol ID: CCSSKA003745
Other IDs: CCSSKA003745
Status last verified: Sep 2021
First submitted: 8 Jun 2021
Last updated: 8 Sep 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Johnson \& Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.

Publications

Aoki V, Lorenzini D, Orfali RL, Zaniboni MC, Oliveira ZNP, Rivitti-Machado MC, Takaoka R, Weber MB, Cestari T, Gontijo B, Ramos AMC, Silva CMR, Cestari SDCP, Souto-Mayor S, Carneiro FR, Cerqueira AMM, Laczynski C, Pires MC. Consensus on the therapeutic management of atopic dermatitis - Brazilian Society of Dermatology. An Bras Dermatol. 2019 Apr;94(2 Suppl 1):67-75. doi: 10.1590/abd1806-4841.2019940210. Epub 2019 Jun 3.
PubMed 31166406
Grice EA, Kong HH, Conlan S, Deming CB, Davis J, Young AC; NISC Comparative Sequencing Program; Bouffard GG, Blakesley RW, Murray PR, Green ED, Turner ML, Segre JA. Topographical and temporal diversity of the human skin microbiome. Science. 2009 May 29;324(5931):1190-2. doi: 10.1126/science.1171700.
PubMed 19478181
Gallo RL, Nakatsuji T. Microbial symbiosis with the innate immune defense system of the skin. J Invest Dermatol. 2011 Oct;131(10):1974-80. doi: 10.1038/jid.2011.182. Epub 2011 Jun 23.
PubMed 21697881
Stamatas GN, Capone K. New findings, and the impact of infant skin microbiota on product development. Cosmetics and Toiletries.
Brazil. Conselho Nacional da Saúde. Resolution Nº 466, December 2012.
Pan-American Health Organization. Good Clinical Practices: American Document. IV Pan-Americana Conference for Harmonization of Pharmaceutical Regulation, 2005.
Blichmann CW, Serup J. Assessment of skin moisture. Measurement of electrical conductance, capacitance and transepidermal water loss. Acta Derm Venereol. 1988;68(4):284-90.
PubMed 2459872
Agner T, Serup J. Comparison of two electrical methods for measurement of skin hydration. An experimental study on an irritant patch test reaction.
Brazil. Agência Nacional de Vigilância Sanitária (ANVISA). Guideline for Safety Assessment of Cosmetic Products. 2 edition, 2012.
Brazil. Agência Nacional de Vigilância Sanitária (ANVISA). Resolution - RDC Nº 10, 03 March 2015.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Single Center, Open-label, Non-randomized Clinical Trial to Evaluate the Safety and Efficacy of a Moisturizer Body Lotion and the Safety and Perceived Efficacy of a Lip Moisturizer in Adults With Atopic Dermatitis Presenting Dermatological Lesion.
ClinicalTrials.gov ID: NCT04950374
Acronym / sponsor ID: CCSSKA003745
Conditions: Atopic Dermatitis
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Study halted prematurely, prior to enrollment of first participant due to change on study design.
Enrolment: 0 participants (actual)
Lead sponsor: Johnson & Johnson Consumer Inc. (J&JCI)Industry (pharma, biotech, devices)
Study start: 26 Jul 2021 (estimated)
Primary completion: 26 Nov 2021 (estimated)
Study completion: 10 Dec 2021 (estimated)
First posted: 6 Jul 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Moisturizer Body Lotion and Lip Moisturizer Regimen	Experimental	Other: Moisturizer Body Lotion, Other: Lip MoisturizerAll participants will receive and use both products.

Who may qualify

Ages: 18 to 59 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Fitzpatrick Skin Type I to VI;
Subjects with mild to moderate atopic dermatitis according to the SCORAD index (mild global score (up to 24) and moderate global score (between 25 to 50), presenting dermatological lesions at the initial study visit;
Generally in good health based on medical history reported by the subject;
Able to read, write, speak and understand Portuguese;
Person who signed the Consent for Photograph Release and Informed Consent Form;

Key exclusion criteria (20 listed)

Subject who attends the Study Site, on the inclusion visit, with leave on moisturizer applied on the instrumental and microbiome evaluation areas;
Present the need for systemic treatments (as in severe atopic dermatitis cases) such as the use of oral corticosteroids or other types of systemic treatments, as assessed by the Study Physician;
Perform topical antimicrobial therapies (such as sodium hypochlorite bath or use of topical antibiotics);
Perform phototherapy;
Use of antimicrobial / antibacterial / anti germ soaps or other cosmetic and hygiene products;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Moisturizer Body LotionThe body lotion product is a moisturizing formulation intended for topical use on the whole body and face. It will be applied at least twice daily.	Other	Moisturizer Body Lotion and Lip Moisturizer Regimen
Lip MoisturizerThe lip product is a moisturizing formulation intended for topical use on the lips. It will be applied at least twice daily.	Other	Moisturizer Body Lotion and Lip Moisturizer Regimen

Primary outcome

Change from baseline of scores of erythema to 21 ± 2 days
Time frame: 21 ± 2 days
At baseline and at 21 ± 2 days, the study physician will evaluate the whole body (including face) and the lips and score the identified erythemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify this skin reaction on the whole body (including face), and on the lips. The change from baseline will be evaluated to assess skin tolerance of both study products.
Change from baseline of the scores of peeling to 21 ± 2 days
Time frame: 21 ± 2 days
At baseline and at 21 ± 2 days, the study physician will evaluate the whole body (including face) and the lips and score the identified peeling according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify this skin reaction on the whole body (including face), and on the lips. The change from baseline will be evaluated to assess skin tolerance of both study products.
Change from baseline of the scores of blistering to 21 ± 2 days
Time frame: 21 ± 2 days
At baseline and at 21 ± 2 days, the study physician will evaluate the whole body (including face) and the lips and score the identified blistering according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify this skin reaction on the whole body (including face), and on the lips. The change from baseline will be evaluated to assess skin tolerance of both study products.
Change from baseline of the scores to edema to 21 ± 2 days
Time frame: 21 ± 2 days
At baseline and at 21 ± 2 days, the study physician will evaluate the whole body (including face) and the lips and score the identified edema according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify this skin reaction on the whole body (including face), and on the lips. The change from baseline will be evaluated to assess skin tolerance of both study products.
Percentage of participants with Adverse Events through 21 ± 2 days
Time frame: Up to 21 ± 2 days
The percentage of participants with AEs, serious adverse events (SAEs), AEs leading to discontinuation and AEs related to skin reactions will be evaluated for skin tolerance up to 21 ± 2 days.
Change from baseline of scores of erythema to 5 ± 1 days
Time frame: 5 ± 1 days
At baseline and at 5 ± 1 days, the study physician will evaluate the whole body (including face) and the lips and score the identified erythemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify this skin reaction on the whole body (including face), and on the lips. The change from baseline will be evaluated to assess skin tolerance of both study products.
Change from baseline of the scores of peeling to 5 ± 1 days
Time frame: 5 ± 1 days
At baseline and at 5 ± 1 days, the study physician will evaluate the whole body (including face) and the lips and score the identified peeling according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify this skin reaction on the whole body (including face), and on the lips. The change from baseline will be evaluated to assess skin tolerance of both study products.
Change from baseline of the scores of blistering to 5 ± 1 days
Time frame: 5 ± 1 days
At baseline and at 5 ± 1 days, the study physician will evaluate the whole body (including face) and the lips and score the identified blistering according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify this skin reaction on the whole body (including face), and on the lips. The change from baseline will be evaluated to assess skin tolerance of both study products.
Change from baseline of the scores of edema to 5 ± 1 days
Time frame: 5 ± 1 days
At baseline and at 5 ± 1 days, the study physician will evaluate the whole body (including face) and the lips and score the identified edema according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify this skin reaction on the whole body (including face), and on the lips. The change from baseline will be evaluated to assess skin tolerance of both study products.

27 secondary outcomes

Change from baseline of Atopic Dermatitis severity based on Scoring Atopic Dermatitis Index (SCORAD) to 21 ± 2 days
Time frame: 21 ± 2 days
Change from baseline to 5 ± 1 days of Atopic Dermatitis severity based on Scoring Atopic Dermatitis Index (SCORAD)
Time frame: 5 ± 1 days
Change from 5 ± 1 days of Atopic Dermatitis severity based on Scoring Atopic Dermatitis Index (SCORAD) to 21 ± 2 days
Time frame: 5 ± 1 days to 21 ± 2 days
Mean change from baseline to 21 ± 2 days in skin hydration level of areas with and without AD lesions
Time frame: 21 ± 2 days
Mean change from baseline to 5 ± 1 days in skin hydration level of areas with and without AD lesions
Time frame: 5 ± 1 days
Mean change from 5 ± 1 days to 21 ± 2 days in skin hydration level of areas with and without AD lesions
Time frame: 5 ± 1 days to 21 ± 2 days
Mean change from baseline to 21 ± 2 days in transepidermal water loss (TEWL) to assess skin barrier integrity of areas with and without AD lesions
Time frame: 21 ± 2 days
Mean change from baseline to 5 ± 1 days in transepidermal water loss (TEWL) to assess skin barrier integrity of areas with and without AD lesions
Time frame: 5 ± 1 days
Mean change from 5 ± 1 days to 21 ± 2 days in transepidermal water loss (TEWL) to assess skin barrier integrity of areas with and without AD lesions
Time frame: 5 ± 1 days to 21 ± 2 days
Mean change from baseline to 21 ± 2 days in the Patient-Oriented Eczema Measure (POEM) total score to assess AD severity
Time frame: 21 ± 2 days
Mean change from baseline to 7 days in the Patient-Oriented Eczema Measure (POEM) total score to assess AD severity
Time frame: 7 days
Mean change from baseline to 14 days in the Patient-Oriented Eczema Measure (POEM) total score to assess AD severity
Time frame: 14 days
Perceived Efficacy of the quality of life at baseline
Time frame: Baseline
Perceived Efficacy in the quality of life at 7 days
Time frame: 7 days
Perceived Efficacy in the quality of life at 14 days
Time frame: 14 days
Perceived Efficacy in the quality of life at 21 ± 2 days
Time frame: 21 ± 2 days
Perceived Efficacy of the moisturizer body lotion at 7 days
Time frame: 7 days
Perceived Efficacy of the moisturizer body lotion at 14 days
Time frame: 14 days
Perceived Efficacy of the moisturizer body lotion at 21 ± 2 days
Time frame: 21 ± 2 days
Perceived Efficacy of the lip moisturizer at 7 days
Time frame: 7 days
Perceived Efficacy of the lip moisturizer at 21 ± 2 days
Time frame: 21 ± 2 days
Determination of types and quantity of bacteria (skin microbiome) of areas with and without AD lesions at baseline
Time frame: Baseline
Determination of types and quantity of bacteria (skin microbiome) of areas with and without AD lesions at 21 ± 2 days
Time frame: 21 ± 2 days
Visual skin condition of areas with and without AD lesions at baseline captured photographically
Time frame: Baseline
Visual skin condition of areas with and without AD lesions at 5 ± 1 days captured photographically
Time frame: 5 ± 1 days
Visual skin condition of areas with and without AD lesions at 21 ± 2 days captured photographically
Time frame: 21 ± 2 days
Testimonial regarding the experience with moisturizer body lotion at 21 ± 2 days
Time frame: 21 ± 2 days

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
Background: PubMed 31166406Aoki V, Lorenzini D, Orfali RL, Zaniboni MC, Oliveira ZNP, Rivitti-Machado MC, Takaoka R, Weber MB, Cestari T, Gontijo B, Ramos AMC, Silva CMR, Cestari SDCP, Souto-Mayor S, Carneiro FR, Cerqueira AMM, Laczynski C, Pires MC. Consensus on the therapeutic management of atopic dermatitis - Brazilian Society of Dermatology. An Bras Dermatol. 2019 Apr;94(2 Suppl 1):67-75. doi: 10.1590/abd1806-4841.2019940210. Epub 2019 Jun 3.
Background: PubMed 19478181Grice EA, Kong HH, Conlan S, Deming CB, Davis J, Young AC; NISC Comparative Sequencing Program; Bouffard GG, Blakesley RW, Murray PR, Green ED, Turner ML, Segre JA. Topographical and temporal diversity of the human skin microbiome. Science. 2009 May 29;324(5931):1190-2. doi: 10.1126/science.1171700.
Background: PubMed 21697881Gallo RL, Nakatsuji T. Microbial symbiosis with the innate immune defense system of the skin. J Invest Dermatol. 2011 Oct;131(10):1974-80. doi: 10.1038/jid.2011.182. Epub 2011 Jun 23.
BackgroundStamatas GN, Capone K. New findings, and the impact of infant skin microbiota on product development. Cosmetics and Toiletries.
BackgroundBrazil. Conselho Nacional da Saúde. Resolution Nº 466, December 2012.
BackgroundPan-American Health Organization. Good Clinical Practices: American Document. IV Pan-Americana Conference for Harmonization of Pharmaceutical Regulation, 2005.
Background: PubMed 2459872Blichmann CW, Serup J. Assessment of skin moisture. Measurement of electrical conductance, capacitance and transepidermal water loss. Acta Derm Venereol. 1988;68(4):284-90.
BackgroundAgner T, Serup J. Comparison of two electrical methods for measurement of skin hydration. An experimental study on an irritant patch test reaction.
BackgroundBrazil. Agência Nacional de Vigilância Sanitária (ANVISA). Guideline for Safety Assessment of Cosmetic Products. 2 edition, 2012.
BackgroundBrazil. Agência Nacional de Vigilância Sanitária (ANVISA). Resolution - RDC Nº 10, 03 March 2015.
Individual participant dataSharing planned: Yes. Johnson \& Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mariane M Mosca, Bsc principal investigator

Allergisa Pesquisa Dermato-Cosmetica LTDA

Questions about this trial

What is this clinical trial studying?

A study testing Moisturizer Body Lotion and Lip Moisturizer in people with Atopic Dermatitis, run by Johnson & Johnson Consumer Inc. (J&JCI).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline of scores of erythema to 21 ± 2 days (time frame: 21 ± 2 days). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04950374, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2021.