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Dermatitis, AtopicNCT05094700

A Study of a Polymeric Surfactant Technology Cleanser in Sensitive Skin Participants

A study testing Non-marketed Cosmetic Facial Cleanser in people with Dermatitis, Atopic and Rosacea, run by Johnson & Johnson Consumer Inc. (J&JCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the efficacy and tolerance of a gentle facial cleanser in participants with sensitive skin (eczema/atopic dermatitis, rosacea, acne, cosmetic intolerance syndrome). Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Dermatitis, Atopic, Rosacea, Acne Vulgaris
What is being tested?
Non-marketed Cosmetic Facial Cleanser
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
1 siteUnited States
Study dates
25 Oct 2021to 30 Nov 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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female 18-70 years of age. Participants who are over 65 years of age must be Coronavirus Disease 2019 (COVID-19) vaccinated. The site will review state issued vaccination cards as proof of vaccination
  • Fitzpatrick Skin Type I-VI, across a range of races and ethnicities with at least 2 participants per each Fitzpatrick skin type
  • Participants who possess mild to moderate eczema/atopic dermatitis, mild to moderate rosacea, mild to moderate acne, or mild to moderate cosmetic intolerance syndrome
  • Participants willing to continue normal course of treatment (within the past 30 days) for their skin disease/condition with no changes during the study
  • Participants must provide written informed consent including consent for photograph release including Health Insurance Portability and Accountability Act (HIPAA) disclosure
  • Able to read, write, speak, and understand English
  • Generally in good health based on medical history reported by the participant
  • Intends to complete the study and is willing and able to follow all study instructions

Who cannot join

  • Has very sensitive skin and/or has known allergies or adverse reactions to common topical skincare products or to ingredients in the investigational product (IP) or have demonstrated a previous hypersensitivity reaction to any of the ingredients in the IP
  • Participants who are pregnant, breast feeding, or planning to become pregnant
  • Participants with clinically significant unstable medical disorders
  • Participants who are unwilling or unable to comply with the requirements of the protocol
  • Participants who have history of a psychological illness or condition that would interfere with their ability to understand and follow the requirements of the study
  • Participants with any planned surgeries and/or invasive medical procedures during the course of the study
Show all 20Show fewer
  • Participants who started hormone replacement therapies (HRT) or hormones for birth control less than 3 months prior to study entry or who plan on starting, stopping, or changing doses of HRT or hormones for birth control during the study
  • Presents with a skin or condition that, in the principal investigator (PI) or designee's opinion, may confound the study results or otherwise be inappropriate for study participation (example, pre-existing or dormant facial dermatologic conditions specifically severe acne or acne conglobata, psoriasis, rosacea, rashes, eczema, atopic dermatitis, skin cancer, many and/or severe excoriations, observable suntan, scars, nevi, tattoo, excessive hair, Et cetera [etc])
  • 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) Immunosuppressive or steroidal drugs within 2 months before Visit 1; b) Non-steroidal anti-inflammatory drugs within 5 days before Visit 1; c) Antihistamines within 2 weeks before Visit 1
  • 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
  • Is simultaneously participating in any other product-use study or has participated in another clinical study on the face in the past 4 weeks
  • Participants currently receiving any anticancer, immunosuppressive treatments/medications (example, azathioprine, belimumab, cyclophosphamide, Enbrel, Imuran, Humira, mycophenolate mofetil, methotrexate, prednisone, Remicade, Stelara.), or radiation as determined by study documentation
  • Participants with a history of immunosuppression/immune deficiency disorders (including [human immunodeficiency virus {HIV} infection or acquired immunodeficiency syndrome {AIDS})
  • Is participating or receiving any professional or aesthetic facial spa procedures during the study
  • Is an employee/contractor or immediate family member of the PI, Study Site, or Sponsor
  • Has a history of a confirmed COVID-19 infection within 30 days prior to Visit 1
  • Has had contact with a COVID-19-infected person within 14 days prior to Visit 1
  • Individual or a member of the individual's household has traveled internationally within 14 days prior to Visit 1
  • Has experienced any of the following self-reported symptoms of COVID-19 within 2 weeks prior to Visit 1: 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, fever, or chest pain/tightness; b) Temperature greater than or equal to (>=) 37.5 degree Celsius (°C) / 99.5 degree Fahrenheit (°F), measured; c) Use of fever reducers within 2 days prior to each on-site visit

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Dermatology Consulting Services, PLLC

    High Point, North Carolina, 27262

Other trials in United States

About this study

Official title: A Single Center, Monadic, Open Label, Four-Week Clinical Trial to Evaluate the Tolerance and of a Polymeric Surfactant Technology Cleanser in Sensitive Skin Patients

The purpose of this study is to evaluate the efficacy and tolerance of a gentle facial cleanser in participants with sensitive skin (eczema/atopic dermatitis, rosacea, acne, cosmetic intolerance syndrome).

Being tested
Non-marketed Cosmetic Facial Cleanser
Medical subject headings
Dermatitis, Atopic, Rosacea, Acne Vulgaris

What participants receive

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

  • Non-marketed Cosmetic Facial CleanserOther

    Participants will apply non-marketed cosmetic facial cleanser on cleanse facial skin, twice daily for 4 weeks.

Study groups in NCT05094700
Study groupRoleWhat they receive
Non-marketed Cosmetic Facial CleanserExperimentalParticipants will receive non-marketed cosmetic facial cleanser to apply on cleanse facial skin, twice daily for 4 weeks.
Receives: Other: Non-marketed Cosmetic Facial Cleanser

What is being measured

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

  1. Mildness of the Facial Cleanser in Participants with Sensitive Skin Based on Investigator and Participant Assessments

    Mildness of the facial cleanser in participants with sensitive skin (eczema/atopic dermatitis, rosacea, acne, cosmetic intolerance syndrome) based on investigator and participant assessments will be reported. It will be evaluated on a scale of 0 to 4 with 0=none, 1=almost clear, 2=mild, 3=moderate, 4=severe.

    Measured: Baseline to Week 4

Secondary outcomes (10)

  1. Investigator Assessment for Tolerability

    Investigator observed tolerability parameters such as: redness/erythema, rash/irritation, peeling/flaking, tactile roughness, and dryness which will be measured using a 5-point ordinal scale (0=none, 1=minimal, 2=mild, 3=moderate, 4=severe).

    Measured: Baseline, Week 2 and Week 4

  2. Investigator Assessment for Efficacy

    Investigators observed efficacy parameters such as: visual smoothness, tactile softness, clarity, radiance, pores, and overall skin appearance which will be measured using a 5-point ordinal scale (0=none, 1=minimal, 2=mild, 3=moderate, 4=severe).

    Measured: Baseline, Week 2 and Week 4

  3. Participant Assessment for Tolerability

    Participants observed tolerability parameters such as: stinging, burning, itching, tightness, redness, flaking/peeling, roughness, dryness and overall sensitivity which will be measured using a 5-point ordinal scale (0=none, 1=minimal, 2=mild, 3=moderate, 4=severe).

    Measured: Baseline, Week 2 and Week 4

  4. Participant Assessment for Efficacy

    Participants observed efficacy parameters such as: smoothness, softness, clarity, radiance, pores and overall skin appearance which will be by using a 5-point ordinal scale (0=none, 1=minimal, 2=mild, 3=moderate, 4=severe).

    Measured: Baseline, Week 2 and Week 4

  5. Photographic Imaging (Right, Left and Frontal Face with Standard Lighting 1 and Cross Polarized Light)

    Photographic imaging (right, left and frontal face with standard lighting 1 and cross polarized light) will be obtained by using VISIA. Each participant's face will be imaged using the photographic imaging system prior to any product use. The imaging system takes a series of two high-resolution images that are captured sequentially in rapid succession to minimize panelist movement and maximize registration of images. Three sets of images will be taken - 45 degree left, 45 degree right, and center of the face.

    Measured: Baseline, Week 2 and Week 4

  6. Non-invasive Assessment: Transepidermal Water Loss (TEWL)

    TEWL measurements of defined target sites of face will be reported. A decrease in TEWL values reflects an improvement in the barrier properties of the skin.

    Measured: Baseline, Week 2 and Week 4

  7. Non-invasive Assessment: Skin pH

    Skin pH measurements of defined target sites of the face will be reported.

    Measured: Baseline, Week 2 and Week 4

  8. Non-invasive Assessment: Skin Hydration Measured by Corneometer

    Skin hydration of defined target sites of face as measured by Corneometer will be reported. An increase in values reflects an improvement in the hydration of the skin.

    Measured: Baseline, Week 2 and Week 4

  9. Non-invasive Assessment: Biomarker Tapes

    Three D-squame tape strips will be taken from a defined target site on the face. D-Squame Standard Sampling Discs (CuDerm Corporation, Dallas, N) will be used to non-invasively collect skin samples from the forehead. The discs are 2.2 centimeters (cm) in diameter and have a homogenous layer of a medical-grade adhesive, which safely removes stratum corneum components and provides optimum visibility of adhering corneocytes. Samples will be collected for the analysis of various skin biomarkers such as skin flakiness, as well as the integrity of the natural moisturizing factors (NMFs), ceramides, free fatty acids, cholesterol via biochemical assays.

    Measured: Baseline, Week 2 and Week 4

  10. Non-invasive Assessment: Facial Swabbing

    A swabbing technique will be used to collect surface skin microflora to determine the effect of the non-marketed cosmetic facial cleanser on the skin microflora.

    Measured: Baseline, Week 2 and Week 4

Timeline

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

  1. First posted26 Oct 2021
  2. Study start25 Oct 2021
  3. Primary completion30 Nov 2021
  4. Study completion30 Nov 2021

Resources

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
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05094700
Sponsor's protocol ID
CCSSKA004090
Other IDs
CCSSKA004090
Status last verified
Nov 2022
First submitted
13 Oct 2021
Last updated
23 Nov 2022
Results posted
No
Data monitoring committee
Yes
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

  • Fitzpatrick TB. The validity and practicality of sun-reactive skin types I through VI. Arch Dermatol. 1988 Jun;124(6):869-71. doi: 10.1001/archderm.124.6.869. No abstract available.

    PubMed 3377516

  • U.S. Census Bureau. (n.d.). About race. Retrieved July 27, 2021, from https://www.census.gov/topics/population/race/about.html

  • U.S. Census Bureau. (n.d.). About the Hispanic population and its origin. Retrieved July 27, 2021, from https://www.census.gov/topics/population/hispanic-origin/about.html

Questions about this trial

What is this clinical trial studying?

A study testing Non-marketed Cosmetic Facial Cleanser in people with Dermatitis, Atopic and Rosacea, 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 8 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: finished, as of the sponsor's last update on 23 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?

Mildness of the Facial Cleanser in Participants with Sensitive Skin Based on Investigator and Participant Assessments (time frame: Baseline to Week 4). 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 NCT05094700, which also lists 3 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 23 Nov 2022.

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