Clinical trial NCT05094700: A Study of a Polymeric Surfactant Technology Cleanser in Sensitive Skin Participants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dermatitis, Atopic
Rosacea
Acne Vulgaris
Sensitive Skin
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2021-10-26
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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).


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Mildness of the Facial Cleanser in Participants with Sensitive Skin Based on Investigator and Participant Assessments
timeFrame: Baseline to Week 4
Secondary outcomes:
measure: Investigator Assessment for Tolerability
timeFrame: Baseline, Week 2 and Week 4
measure: Investigator Assessment for Efficacy
timeFrame: Baseline, Week 2 and Week 4
measure: Participant Assessment for Tolerability
timeFrame: Baseline, Week 2 and Week 4
measure: Participant Assessment for Efficacy
timeFrame: Baseline, Week 2 and Week 4
measure: Photographic Imaging (Right, Left and Frontal Face with Standard Lighting 1 and Cross Polarized Light)
timeFrame: Baseline, Week 2 and Week 4
measure: Non-invasive Assessment: Transepidermal Water Loss (TEWL)
timeFrame: Baseline, Week 2 and Week 4
measure: Non-invasive Assessment: Skin pH
timeFrame: Baseline, Week 2 and Week 4
measure: Non-invasive Assessment: Skin Hydration Measured by Corneometer
timeFrame: Baseline, Week 2 and Week 4
measure: Non-invasive Assessment: Biomarker Tapes
timeFrame: Baseline, Week 2 and Week 4
measure: Non-invasive Assessment: Facial Swabbing
timeFrame: Baseline, Week 2 and Week 4
Other outcomes:
Locations:
city: High Point
country: United States
facility: Dermatology Consulting Services, PLLC
state: North Carolina
Study officials:
affiliation: Dermatology Consulting Services, PLLC
name: Zoe Diana Draelos, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: U.S. Census Bureau. (n.d.). About race. Retrieved July 27, 2021, from https://www.census.gov/topics/population/race/about.html
citation: 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