Dermatitis, AtopicNCT05226143
A Study of an Eczema Spot Treatment in Providing Eczema Symptoms Relief and Lasting Itch Relief to Affected Skin Area
A study testing Gel Cream in people with Dermatitis, Atopic, run by Johnson & Johnson Consumer Inc. (J&JCI) at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the efficacy (assessed by clinical evaluation of eczema/atopic lesion severity [atopic dermatitis severity index {ADSI} scoring] and perceived benefits in itch [visual analog score {VAS} scoring]) and tolerability (assessed by clinical grading) of an investigational spot… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- Gel Cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2022to 9 Mar 2022
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fitzpatrick Skin Type I, II, III, IV, V, or VI
- Self-reported natural skin tone Pale/fair to light white, White to light beige, Beige to light tan/light olive, Medium tan/medium olive to light brown, Medium brown to dark brown, or Darkest brown to darkest black targeting the following: a) Skin tones "Pale/fair to light white" and "White to light beige" (at least number of participants (n)= 4); b) Skin tones "Beige to light tan/light olive" and "Medium tan/medium olive to light brown" (at least n = 4); c) Skin tones "Medium brown to dark brown" and "Darkest brown to darkest black" (at least n = 4)
- Men who are regular shavers (at least 3 times per week) and do not have beards. A mustache and/or small goatee is allowed as long as the majority of the face and neck are shaved
- Has mild to moderate eczema severity rating at Visit 1, defined as a score of 3 - 7.5 on the Rajka and Langeland Severity Index
- Has at least 1 lesion area; either on face or body at Visit 1 with a score of 5 - 12 on the Atopic Dermatitis Severity Index (ADSI) score, ADSI pruritus sub-score of 1 - 2 (mild - moderate), and ADSI erythema sub-score of at least 2 (moderate) to be followed for the duration of the study
- Has a Visual Analog Score (VAS) score greater than or equal to (>=) 4 for itch on the target lesion
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- Has experienced a recent (within the past 1 year) itch flare up and is currently experiencing preflare up symptoms at Visit 1
- Is a regular user of body moisturizers, defined as 2 -3 times per week
- Has not had any facial treatments in the past 6 months and is willing to withhold all facial treatments during the course of the study including facials, facial peels, photo facials, laser treatments, dermabrasion, botulinum toxin (Botox), injectable filler treatments, intense pulsed light (IPL), acid treatments, tightening treatments, facial plastic surgery, or any other treatment administered by a physician or skin care professional designed to improve the appearance or firmness of facial skin
- Generally in good health based on medical history reported by the participant
- Able to read, write, speak, and understand English
- Individual has signed the Consent for Photograph Release and informed consent document (ICD) including Health Insurance Portability and Accountability Act (HIPAA) disclosure
- Intends to complete the study and is willing and able to follow all study instructions
Who cannot join
- Has known allergies or adverse reactions to common topical skincare products or ingredients in the investigational study material (ISM)
- Presents with a health condition and/or pre-existing acute or chronic dermatologic conditions (example, psoriasis, rosacea, rashes, many and/or severe excoriations, Et cetera [etc.]) that could interfere with the outcome of the study or be deemed inappropriate for study participation as determined by the principal investigator (PI)
- Has severe eczema severity rating at Visit 1, defined as a score of 8 - 9 on the Rajka and Langeland Severity Index
- Has a bacterial, fungal, or viral skin infection or is susceptible to cutaneous infections
- Is currently using an over-the-counter (OTC) moisturizer specifically indicated for eczema (Active Ingredient: 1 percent [%] - 2% Colloidal Oatmeal stated in the Drug Facts Box) within 3 days prior to Visit 1
- Is currently using Class I-III topical corticosteroids or systemic medications that will affect or have an indirect effect on his/her eczema (including but not limited to betamethasone, clobetasol, desoximetasone, diflorasone, fluocinonide, fluticasone, halcinonide, halobetasol, and mometasone) or have used the aforementioned medications within 4 weeks before study enrollment. (participants on a stabilized regimen of antihistamines for allergy are permitted into the study)
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- Has a history of immunosuppression/immune deficiency disorders (including human immunodeficiency virus [HIV] infection or acquired immunodeficiency syndrome [AIDS]) or currently using immunosuppressive medications (example, azathioprine, belimumab, cyclophosphamide, Enbrel, Imuran, Humira, mycophenolate mofetil, methotrexate, prednisone, Remicade, Stelara.), and/or radiotherapy
- Has used an over-the-counter (OTC) hydrocortisone/steroid and/or prescribed topical medications within 2 weeks prior to Visit 1
- Has used an OTC anti-itch spot treatment within 1 week prior to Visit 1
- Has applied moisturizers on the face and/or body within 3 days prior to Visit 1
- Has a history of a confirmed or suspected COVID-19 infection within 30 days prior to the study visit.
- Within 14 days prior to Visit 1, has been in close contact (exposure within 6 feet for a cumulative time of 15 minutes or more over a 24-hour period) with anyone who has been infected with COVID-19
- Is under a COVID-19 isolation/quarantine order
- Has experienced any of the following self-reported symptoms of COVID-19 within 2 weeks prior to the study visit: a) Unexplained cough, shortness of breath/difficulty breathing, fatigue, body aches (headaches, muscle pain, stomachaches), conjunctivitis, loss of smell, loss of taste, poor appetite, nausea, vomiting, diarrhea, palpitations, or chest pain/tightness; b) Temperature greater than or equal to (>=) 37.2 degree Celsius (°C) / 99 degree Fahrenheit (°F), measured; c) Use of fever or pain reducers within 2 days prior to the study visit
- 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: a) Prescription medication (oral or topical) that can make skin more sensitive or have an effect on the skin (that is, antibiotics, hormones, insulin, etc.) within 6 weeks before Visit 1; b) Immunosuppressive or steroidal drugs within 2 months before Visit 1; c) Non-steroidal anti-inflammatory drugs within 5 days before Visit 1; d) Antihistamines within 2 weeks before Visit 1
- Is self-reported to be breastfeeding, 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
- Has started prescription testosterone therapy less than 3 months prior to study entry or planning on starting, stopping, or changing doses of testosterone therapy during the study (example, testosterone cypionate, testosterone enanthate, testosterone pellet, testosterone undecanoate) or on a testosterone booster or prescription testosterone (example, DHEA, Omnadren, Sustanon, testosterone cypionate, testosterone enanthate, testosterone propionate, testosterone phenylpropionate, tribulus)
- Has planned surgeries and/or invasive medical procedures during the course of the study
- Is simultaneously participating in any other clinical study or has participated in any product-use study within 30 days prior to Visit 1
- Is an employee/contractor or immediate family member of the PI, Study Site, or Sponsor
Trial locations and contacts
1 site in 1 country.
United States1 site
Dermatology Consulting Services, PLLC
High Point, North Carolina, 27262
About this study
Official title: A Single Center, Clinical Study to Determine the Safety and Efficacy of an Eczema Spot Treatment in Providing Eczema Symptoms Relief and Lasting Itch Relief to Affected Skin Area
The purpose of this study is to evaluate the efficacy (assessed by clinical evaluation of eczema/atopic lesion severity [atopic dermatitis severity index {ADSI} scoring] and perceived benefits in itch [visual analog score {VAS} scoring]) and tolerability (assessed by clinical grading) of an investigational spot treatment Gel Cream when used on a target site of participants with mild to moderate atopic dermatitis.
- Conditions
- Dermatitis, Atopic
- Being tested
- Gel Cream
- Keywords
- Itching, Pruritus, Dryness, Excoriation, Xerosis, Eczema, Atopic Dermatitis
- Medical subject headings
- Dermatitis, Atopic, Pruritus, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gel CreamOther
Also called Participants will apply gel cream on facial skin and target lesions for up to 14 days.
Gel Cream
| Study group | Role | What they receive |
|---|---|---|
| Gel Cream | Experimental | Participants will be provided with the Gel Cream to apply on clean, dry face (facial skin) once per day and on the target lesion on the face or body at least 2 times per day or more as needed, in the morning and at night for 14 days. Receives: Other: Gel Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rajka and Langeland Severity Index Score of Target Lesion
Rajka and langeland severity index score of target lesion will be reported. The score is based on the grading of: (i) eczema extent based on percent (%) body area affected, (ii) eczema course based on the number of months with remission during the previous year, and (iii) eczema intensity expressed in terms of nocturnal sleep disturbance due to itch. Each parameter is scored on a scale of 1-3, and the scores are summed. The Rajka and Langeland severity score ranges from 3 to 9 (3-4=mild, 4.5-7.5=moderate, and 8-9=severe).
Measured: At Screening
Atopic Dermatitis Severity Index (ADSI) Score of Target Lesion
ADSI score of target lesion will be reported. ADSI is a scoring system that reflects the severity of a target eczema lesion. The ADSI score is a sum of scores for 5 different parameters - erythema, pruritus, exudation, excoriation, lichenification- which are each measured on a scale of 0 (none) to 3 (severe). The total score can range from 0 (no eczema signs) to 15 (severe eczema lesion).
Measured: Up to 14 days
Dryness of Target Lesion
Dryness of target lesion will be reported. It will be evaluated on a scale of 0 to 3 with 0=none (no dryness), 1=mild (slight, but definite dryness), 2=moderate (definite dryness), and 3=severe (marked dryness), with higher scores indicating a worse outcome.
Measured: Up to 14 days
Tactile Roughness of Target Lesion
Tactile roughness of target lesion will be reported. It will be evaluated on a scale of 0 to 3 with 0=none (skin perfectly smooth), 1=mild (mild roughness), 2=moderate (moderate roughness), and 3=severe (severe roughness), with higher scores indicating a worse outcome.
Measured: Up to 14 days
Erythema of Target Lesion
Erythema of target lesion (derived from ADSI sub-score) will be reported. It will be evaluated on a scale of 0 to 3 with 0=none (no redness), 1=mild (mildly detectable erythema; pink), 2=moderate (dull red; clearly distinguishable), and 3=severe (deep, dark red; marked and extensive), with higher scores indicating a worse outcome.
Measured: Up to 14 days
Pruritus of Target Lesion
Pruritus of target lesion (derived from ADSI sub-score) will be reported. It will be evaluated on a scale of 0 to 3 with 0=none (no itching), 1=mild (occasional, slight itching), 2=moderate (frequent or intermittent itching; does not disturb sleep), and 3=severe (constant, bothersome itching that disturbs sleep or normal activity), with higher scores indicating a worse outcome.
Measured: Up to 14 days
Skin Tone of Lesion Compared to Normal Overall Skin Tone
Skin tone of lesion compared to normal overall skin tone will be reported. It will be evaluated on a scale of 0 to 9 with 0=none (same overall tone [color] of normal, non-involved lesional skin), 1-3=mild (slightly different color/skin tone compared to normal, non-involved lesional skin), 4-6=moderate (moderately different color/skin tone compared to normal, non-involved lesional skin), and 7-9=severe (marked, severe difference in color/skin tone [either hypo/hyper pigmented, red] compared to normal, non-involved lesional skin), with higher scores indicating a worse outcome.
Measured: Up to 14 days
Overall Irritation of Facial Skin
Overall irritation of the facial skin will be reported. It will be evaluated on a scale of 0 to 4 with 0=none (no Reaction), 1=mild (definite pink to red coloration), 2=moderate (increased redness, possible edema), 3=severe (very red, with edema and vesiculation), 4=very severe (deep red, swelling and edema with signs of bullae formation and necrosis), with higher scores indicating a worse outcome.
Measured: Up to 14 days
Itch Assessment of Target Lesion
Itch assessment of target lesion will be evaluated by using visual analog scale (VAS). Participants will be asked to rate his/her itch severity of the target lesion using VAS as score ranges from 0 (no itch) to 10 (worst itch possible).
Measured: Up to 14 days
Soothing Assessments of Target Lesion
Soothing assessment based on participants self-assessment questionnaire score will be reported. Participants will be asked to complete the following question: 1) the product soothed/calmed the eczema test site area; 2) the eczema test site area feels soothed/calmed. Participant responses for each question will have 5 response options such as: Strongly agree, Agree, Neither Agree nor Disagree, Disagree, Strongly Disagree.
Measured: Up to 14 days
Cooling Assessment of Target Lesion
Cooling assessment of target lesion based on participants self-assessment questionnaire score will be reported. Participants will be asked to complete the following question: "The product provided a cooling sensation to the test site area". Participant responses for the question will have 5 response options such as: Strongly agree, Agree, Neither Agree nor Disagree, Disagree, Strongly Disagree.
Measured: Baseline (Day 0)
Burning/Stinging Sensation of the Facial Skin
Burning/Stinging sensation of the facial skin will be reported. It will be evaluated on a scale of 0 to 3 with 0=none (no burning/stinging of the treatment area), 1=mild (slight burning/stinging sensation of the treatment area; slightly bothersome), 2=moderate (definite burning/stinging of the treatment area that is somewhat bothersome), and 3=severe (intense burning/stinging sensation of the treatment area that causes definite discomfort and may interrupt daily activities and/or sleep), with higher scores indicating a worse outcome.
Measured: Up to 14 days
Skin pH Measurements of Target Lesion
Skin pH measurement of target lesion will be reported. It will be measured using a DermaLab pH probe attached to a Cortex Technologies computer platform.
Measured: Up to 14 days
Skin Hydration of Target Lesion as Measured by Corneometer
Skin hydration of target lesion as measured by Corneometer will be reported. Corneometer measurements will be taken using a DermaLab pin probe attached to a Cortex Technologies computer platform.
Measured: Up to 14 days
Transepidermal Water Loss (TEWL) Measurement of Target Lesion
TEWL measurement of target lesion will be assessed. TEWL measurements will be taken using a RG-1 Evaporimeter (cyberDERM) equipped with DermaLab (Cortex Technologies) probes in conjunction with a computer.
Measured: Up to 14 days
Digital Photograph of Target Lesion
Digital photograph of target tension will be reported. The images of each participant's target lesion will be captured using a Canfield D90 digital Slue camera using visible light. This will allow fixed to stop reproducible images to be obtained. A close-up image will be taken of each target lesion with an appropriately draped background.
Measured: Up to 14 days
Microbiome Sampling of Target Lesion
The surface skin microbiome will be collected from target lesion. A swabbing technique will be used to collect surface skin microflora for analysis to determine the effect of the gel cream on the skin microflora.
Measured: Up to 14 days
Itch Quality of Life (ItchQOL) Questionnaire
ItchQOl is a 54-item questionnaire assessing the pruritus-specific disease burden on 2 domains: frequency and bother. The responses to the frequency items are scored on a 1 (never) to 5 (all the time) scale and the responses to the bother items are scored on a 1 (not bothered) to 5 (severely bothered) scale. Higher scores indicate a more adverse impact on quality of life.
Measured: Up to 14 days
Dermatology Life Quality Index (DLQI) Score
The DLQI is a validated questionnaire used to measure the impact of atopic dermatitis (AD) disease symptoms and treatment on health-related quality of life. DLQI consisting of a set of 10 questions which assess quality of life over the past week. Responses to each questions were assessed on a scale of 0 to 3, where 0 is "not at all or not relevant" and 3 is "very much". Scores from all 10 questions added up to give total DLQI scores ranged from 0 (no effect at all on participant's life) to 30 (extremely large effect on participant's life), higher scores indicated more impact on quality of life.
Measured: Up to 14 days
Final Assessment Questionnaire
Final assessment questionnaire will be completed by the participant to provide subjective assessment of the gel cream. Participant responses for each question will have 5 response options such as: Strongly agree, Agree, Neither Agree nor Disagree, Disagree, Strongly Disagree.
Measured: At Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start21 Feb 2022
- Primary completion9 Mar 2022
- Study completion9 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dermatitis, AtopicStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zoe Diana Draelos, M.D., Principal investigator, Dermatology Consulting Services, High Point NC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05226143
- Sponsor's protocol ID
- CCSSKA004706
- Status last verified
- Nov 2022
- First submitted
- 26 Jan 2022
- Last updated
- 14 Nov 2022
- 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
Rajka G, Langeland T. Grading of the severity of atopic dermatitis. Acta Derm Venereol Suppl (Stockh). 1989;144:13-4. doi: 10.2340/000155551441314.
PubMed 2800895
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Clinical Study to Determine the Safety and Efficacy of an Eczema Spot Treatment in Providing Eczema Symptoms Relief and Lasting Itch Relief to Affected Skin Area
- ClinicalTrials.gov ID
- NCT05226143
- Acronym / sponsor ID
- CCSSKA004706
- Conditions
- Dermatitis, Atopic
- Keywords
- Itching, Pruritus, Dryness, Excoriation, Xerosis, Eczema, Atopic Dermatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)Industry (pharma, biotech, devices)
- Study start
- 21 Feb 2022 (actual)
- Primary completion
- 9 Mar 2022 (actual)
- Study completion
- 9 Mar 2022 (actual)
- First posted
- 7 Feb 2022 (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.
The purpose of this study is to evaluate the efficacy (assessed by clinical evaluation of eczema/atopic lesion severity [atopic dermatitis severity index {ADSI} scoring] and perceived benefits in itch [visual analog score {VAS} scoring]) and tolerability (assessed by clinical grading) of an investigational spot treatment Gel Cream when used on a target site of participants with mild to moderate atopic dermatitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gel Cream | Experimental | Other: Gel CreamParticipants will be provided with the Gel Cream to apply on clean, dry face (facial skin) once per day and on the target lesion on the face or body at least 2 times per day or more as needed, in the morning and at night for 14 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Fitzpatrick Skin Type I, II, III, IV, V, or VI
- Self-reported natural skin tone Pale/fair to light white, White to light beige, Beige to light tan/light olive, Medium tan/medium olive to light brown, Medium brown to dark brown, or Darkest brown to darkest black targeting the following: a) Skin tones "Pale/fair to light white" and "White to light beige" (at least number of participants (n)= 4); b) Skin tones "Beige to light tan/light olive" and "Medium tan/medium olive to light brown" (at least n = 4); c) Skin tones "Medium brown to dark brown" and "Darkest brown to darkest black" (at least n = 4)
- Men who are regular shavers (at least 3 times per week) and do not have beards. A mustache and/or small goatee is allowed as long as the majority of the face and neck are shaved
- Has mild to moderate eczema severity rating at Visit 1, defined as a score of 3 - 7.5 on the Rajka and Langeland Severity Index
- Has at least 1 lesion area; either on face or body at Visit 1 with a score of 5 - 12 on the Atopic Dermatitis Severity Index (ADSI) score, ADSI pruritus sub-score of 1 - 2 (mild - moderate), and ADSI erythema sub-score of at least 2 (moderate) to be followed for the duration of the study
Key exclusion criteria (22 listed)
- Has known allergies or adverse reactions to common topical skincare products or ingredients in the investigational study material (ISM)
- Presents with a health condition and/or pre-existing acute or chronic dermatologic conditions (example, psoriasis, rosacea, rashes, many and/or severe excoriations, Et cetera [etc.]) that could interfere with the outcome of the study or be deemed inappropriate for study participation as determined by the principal investigator (PI)
- Has severe eczema severity rating at Visit 1, defined as a score of 8 - 9 on the Rajka and Langeland Severity Index
- Has a bacterial, fungal, or viral skin infection or is susceptible to cutaneous infections
- Is currently using an over-the-counter (OTC) moisturizer specifically indicated for eczema (Active Ingredient: 1 percent [%] - 2% Colloidal Oatmeal stated in the Drug Facts Box) within 3 days prior to Visit 1
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 |
|---|---|---|
| Gel CreamAlso: Participants will apply gel cream on facial skin and target lesions for up to 14 days.Gel Cream | Other | Gel Cream |
Primary outcome
Rajka and Langeland Severity Index Score of Target Lesion
Time frame: At Screening
Rajka and langeland severity index score of target lesion will be reported. The score is based on the grading of: (i) eczema extent based on percent (%) body area affected, (ii) eczema course based on the number of months with remission during the previous year, and (iii) eczema intensity expressed in terms of nocturnal sleep disturbance due to itch. Each parameter is scored on a scale of 1-3, and the scores are summed. The Rajka and Langeland severity score ranges from 3 to 9 (3-4=mild, 4.5-7.5=moderate, and 8-9=severe).
Atopic Dermatitis Severity Index (ADSI) Score of Target Lesion
Time frame: Up to 14 days
ADSI score of target lesion will be reported. ADSI is a scoring system that reflects the severity of a target eczema lesion. The ADSI score is a sum of scores for 5 different parameters - erythema, pruritus, exudation, excoriation, lichenification- which are each measured on a scale of 0 (none) to 3 (severe). The total score can range from 0 (no eczema signs) to 15 (severe eczema lesion).
Dryness of Target Lesion
Time frame: Up to 14 days
Dryness of target lesion will be reported. It will be evaluated on a scale of 0 to 3 with 0=none (no dryness), 1=mild (slight, but definite dryness), 2=moderate (definite dryness), and 3=severe (marked dryness), with higher scores indicating a worse outcome.
Tactile Roughness of Target Lesion
Time frame: Up to 14 days
Tactile roughness of target lesion will be reported. It will be evaluated on a scale of 0 to 3 with 0=none (skin perfectly smooth), 1=mild (mild roughness), 2=moderate (moderate roughness), and 3=severe (severe roughness), with higher scores indicating a worse outcome.
Erythema of Target Lesion
Time frame: Up to 14 days
Erythema of target lesion (derived from ADSI sub-score) will be reported. It will be evaluated on a scale of 0 to 3 with 0=none (no redness), 1=mild (mildly detectable erythema; pink), 2=moderate (dull red; clearly distinguishable), and 3=severe (deep, dark red; marked and extensive), with higher scores indicating a worse outcome.
Pruritus of Target Lesion
Time frame: Up to 14 days
Pruritus of target lesion (derived from ADSI sub-score) will be reported. It will be evaluated on a scale of 0 to 3 with 0=none (no itching), 1=mild (occasional, slight itching), 2=moderate (frequent or intermittent itching; does not disturb sleep), and 3=severe (constant, bothersome itching that disturbs sleep or normal activity), with higher scores indicating a worse outcome.
Skin Tone of Lesion Compared to Normal Overall Skin Tone
Time frame: Up to 14 days
Skin tone of lesion compared to normal overall skin tone will be reported. It will be evaluated on a scale of 0 to 9 with 0=none (same overall tone [color] of normal, non-involved lesional skin), 1-3=mild (slightly different color/skin tone compared to normal, non-involved lesional skin), 4-6=moderate (moderately different color/skin tone compared to normal, non-involved lesional skin), and 7-9=severe (marked, severe difference in color/skin tone [either hypo/hyper pigmented, red] compared to normal, non-involved lesional skin), with higher scores indicating a worse outcome.
Overall Irritation of Facial Skin
Time frame: Up to 14 days
Overall irritation of the facial skin will be reported. It will be evaluated on a scale of 0 to 4 with 0=none (no Reaction), 1=mild (definite pink to red coloration), 2=moderate (increased redness, possible edema), 3=severe (very red, with edema and vesiculation), 4=very severe (deep red, swelling and edema with signs of bullae formation and necrosis), with higher scores indicating a worse outcome.
Itch Assessment of Target Lesion
Time frame: Up to 14 days
Itch assessment of target lesion will be evaluated by using visual analog scale (VAS). Participants will be asked to rate his/her itch severity of the target lesion using VAS as score ranges from 0 (no itch) to 10 (worst itch possible).
Soothing Assessments of Target Lesion
Time frame: Up to 14 days
Soothing assessment based on participants self-assessment questionnaire score will be reported. Participants will be asked to complete the following question: 1) the product soothed/calmed the eczema test site area; 2) the eczema test site area feels soothed/calmed. Participant responses for each question will have 5 response options such as: Strongly agree, Agree, Neither Agree nor Disagree, Disagree, Strongly Disagree.
Cooling Assessment of Target Lesion
Time frame: Baseline (Day 0)
Cooling assessment of target lesion based on participants self-assessment questionnaire score will be reported. Participants will be asked to complete the following question: "The product provided a cooling sensation to the test site area". Participant responses for the question will have 5 response options such as: Strongly agree, Agree, Neither Agree nor Disagree, Disagree, Strongly Disagree.
Burning/Stinging Sensation of the Facial Skin
Time frame: Up to 14 days
Burning/Stinging sensation of the facial skin will be reported. It will be evaluated on a scale of 0 to 3 with 0=none (no burning/stinging of the treatment area), 1=mild (slight burning/stinging sensation of the treatment area; slightly bothersome), 2=moderate (definite burning/stinging of the treatment area that is somewhat bothersome), and 3=severe (intense burning/stinging sensation of the treatment area that causes definite discomfort and may interrupt daily activities and/or sleep), with higher scores indicating a worse outcome.
Skin pH Measurements of Target Lesion
Time frame: Up to 14 days
Skin pH measurement of target lesion will be reported. It will be measured using a DermaLab pH probe attached to a Cortex Technologies computer platform.
Skin Hydration of Target Lesion as Measured by Corneometer
Time frame: Up to 14 days
Skin hydration of target lesion as measured by Corneometer will be reported. Corneometer measurements will be taken using a DermaLab pin probe attached to a Cortex Technologies computer platform.
Transepidermal Water Loss (TEWL) Measurement of Target Lesion
Time frame: Up to 14 days
TEWL measurement of target lesion will be assessed. TEWL measurements will be taken using a RG-1 Evaporimeter (cyberDERM) equipped with DermaLab (Cortex Technologies) probes in conjunction with a computer.
Digital Photograph of Target Lesion
Time frame: Up to 14 days
Digital photograph of target tension will be reported. The images of each participant's target lesion will be captured using a Canfield D90 digital Slue camera using visible light. This will allow fixed to stop reproducible images to be obtained. A close-up image will be taken of each target lesion with an appropriately draped background.
Microbiome Sampling of Target Lesion
Time frame: Up to 14 days
The surface skin microbiome will be collected from target lesion. A swabbing technique will be used to collect surface skin microflora for analysis to determine the effect of the gel cream on the skin microflora.
Itch Quality of Life (ItchQOL) Questionnaire
Time frame: Up to 14 days
ItchQOl is a 54-item questionnaire assessing the pruritus-specific disease burden on 2 domains: frequency and bother. The responses to the frequency items are scored on a 1 (never) to 5 (all the time) scale and the responses to the bother items are scored on a 1 (not bothered) to 5 (severely bothered) scale. Higher scores indicate a more adverse impact on quality of life.
Dermatology Life Quality Index (DLQI) Score
Time frame: Up to 14 days
The DLQI is a validated questionnaire used to measure the impact of atopic dermatitis (AD) disease symptoms and treatment on health-related quality of life. DLQI consisting of a set of 10 questions which assess quality of life over the past week. Responses to each questions were assessed on a scale of 0 to 3, where 0 is "not at all or not relevant" and 3 is "very much". Scores from all 10 questions added up to give total DLQI scores ranged from 0 (no effect at all on participant's life) to 30 (extremely large effect on participant's life), higher scores indicated more impact on quality of life.
Final Assessment Questionnaire
Time frame: At Day 14
Final assessment questionnaire will be completed by the participant to provide subjective assessment of the gel cream. Participant responses for each question will have 5 response options such as: Strongly agree, Agree, Neither Agree nor Disagree, Disagree, Strongly Disagree.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Background: PubMed 2800895Rajka G, Langeland T. Grading of the severity of atopic dermatitis. Acta Derm Venereol Suppl (Stockh). 1989;144:13-4. doi: 10.2340/000155551441314.
- Related InfoLink provided by the sponsor.
- 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.
Zoe Diana Draelos, M.D. principal investigator
Dermatology Consulting Services, High Point NC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gel Cream in people with Dermatitis, Atopic, run by Johnson & Johnson Consumer Inc. (J&JCI) at 1 site in United States.
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 13 inclusion and 22 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: finished, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rajka and Langeland Severity Index Score of Target Lesion (time frame: At Screening). The study lists 20 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 NCT05226143, which also lists 1 linked publication.
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 14 Nov 2022.