A Study of a Polymeric Surfactant Technology Cleanser in Sensitive Skin Participants
Completed · Not applicable
Conditions studied: Dermatitis, Atopic, Rosacea, Acne Vulgaris, Sensitive Skin
In brief
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).
Key facts
- Study ID
- NCT05094700
- Run by
- Johnson & Johnson Consumer Inc. (J&JCI)
- People needed
- 85
- Starts
- 2021-10-25
- Expected to finish
- 2021-11-30
- Last updated by the study team
- 2022-11-23
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Dermatology Consulting Services, PLLC — High Point, North Carolina, United States
Full record on ClinicalTrials.gov
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