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

NCT ID: NCT05094700

Last Updated: 2022-11-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-25
• Study Completion Date: 2021-11-30

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).

Conditions

Dermatitis, Atopic; Rosacea; Acne Vulgaris; Sensitive Skin

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Non-marketed Cosmetic Facial Cleanser

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

Group Type: EXPERIMENTAL

Non-marketed Cosmetic Facial Cleanser

Intervention Type: OTHER

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

Interventions

Non-marketed Cosmetic Facial Cleanser

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson Consumer Inc. (J&JCI)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zoe Diana Draelos, MD

Role: PRINCIPAL_INVESTIGATOR

Dermatology Consulting Services, PLLC

Locations

Dermatology Consulting Services, PLLC

High Point, North Carolina, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 3377516 (View on PubMed)

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

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

Related Links

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Related Info

Other Identifiers

CCSSKA004090

Identifier Type: OTHER

Identifier Source: secondary_id

CCSSKA004090

Identifier Type: -

Identifier Source: org_study_id