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

NCT05094700 | Completed DMC

• 1 other identifier: CCSSKA004090
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (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.

  Baseline to Week 4

Secondary Outcomes (10)

• Investigator Assessment for Tolerability

  Baseline, Week 2 and Week 4

• Investigator Assessment for Efficacy

  Baseline, Week 2 and Week 4

• Participant Assessment for Tolerability

  Baseline, Week 2 and Week 4

• Participant Assessment for Efficacy

  Baseline, Week 2 and Week 4

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

  Baseline, Week 2 and Week 4

Study Arms (1)

Non-marketed Cosmetic Facial Cleanser

EXPERIMENTAL

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

Other: Non-marketed Cosmetic Facial Cleanser

Interventions

Non-marketed Cosmetic Facial Cleanser OTHER

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

Non-marketed Cosmetic Facial Cleanser

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Johnson & Johnson Consumer Inc. (J&JCI): lead

Study Sites (1)

Dermatology Consulting Services, PLLC

High Point, North Carolina, 27262, United States

Location

Related Publications (3)

• 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.

  PMID: 3377516 BACKGROUND

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

  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

  BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Dermatitis, Atopic; Rosacea; Acne Vulgaris

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Acneiform Eruptions; Sebaceous Gland Diseases

Study Officials

• Zoe Diana Draelos, MD

  Dermatology Consulting Services, PLLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2021
• First Posted: October 26, 2021
• Study Start: October 25, 2021
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: November 23, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)