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

Johnson & Johnson (J&J)

Status

Completed

Conditions

Dermatitis, Atopic

Sensitive Skin

Acne Vulgaris

Rosacea

Treatments

Other: Non-marketed Cosmetic Facial Cleanser

Study type

Interventional

Funder types

Industry

Identifiers

NCT05094700

CCSSKA004090 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment

85 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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