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

Acne Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05094700
• Other study ID #: CCSSKA004090
• Secondary ID: CCSSKA004090
• Status: Completed
• Phase: N/A
• Start date: October 25, 2021
• Est. completion date: November 30, 2021

Study information

• Verified date: November 2022
• Source: Johnson & Johnson Consumer and Personal Products Worldwide
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: November 30, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Acne Vulgaris
• Dermatitis
• Dermatitis, Atopic
• Hypersensitivity
• Rosacea
• Sensitive Skin

Intervention

Other:
• Non-marketed Cosmetic Facial Cleanser
Participants will apply non-marketed cosmetic facial cleanser on cleanse facial skin, twice daily for 4 weeks.

Locations

Country	Name	City	State
United States	Dermatology Consulting Services, PLLC	High Point	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Consumer Inc. (J&JCI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Fitzpatrick TB. The validity and practicality of sun-reactive skin types I through VI. Arch Dermatol. 1988 Jun;124(6):869-71. — View Citation

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

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Investigator Assessment for Tolerability	Investigator observed tolerability parameters such as: redness/erythema, rash/irritation, peeling/flaking, tactile roughness, and dryness which will be measured using a 5-point ordinal scale (0=none, 1=minimal, 2=mild, 3=moderate, 4=severe).	Baseline, Week 2 and Week 4
Secondary	Investigator Assessment for Efficacy	Investigators observed efficacy parameters such as: visual smoothness, tactile softness, clarity, radiance, pores, and overall skin appearance which will be measured using a 5-point ordinal scale (0=none, 1=minimal, 2=mild, 3=moderate, 4=severe).	Baseline, Week 2 and Week 4
Secondary	Participant Assessment for Tolerability	Participants observed tolerability parameters such as: stinging, burning, itching, tightness, redness, flaking/peeling, roughness, dryness and overall sensitivity which will be measured using a 5-point ordinal scale (0=none, 1=minimal, 2=mild, 3=moderate, 4=severe).	Baseline, Week 2 and Week 4
Secondary	Participant Assessment for Efficacy	Participants observed efficacy parameters such as: smoothness, softness, clarity, radiance, pores and overall skin appearance which will be by using a 5-point ordinal scale (0=none, 1=minimal, 2=mild, 3=moderate, 4=severe).	Baseline, Week 2 and Week 4
Secondary	Photographic Imaging (Right, Left and Frontal Face with Standard Lighting 1 and Cross Polarized Light)	Photographic imaging (right, left and frontal face with standard lighting 1 and cross polarized light) will be obtained by using VISIA. Each participant's face will be imaged using the photographic imaging system prior to any product use. The imaging system takes a series of two high-resolution images that are captured sequentially in rapid succession to minimize panelist movement and maximize registration of images. Three sets of images will be taken - 45 degree left, 45 degree right, and center of the face.	Baseline, Week 2 and Week 4
Secondary	Non-invasive Assessment: Transepidermal Water Loss (TEWL)	TEWL measurements of defined target sites of face will be reported. A decrease in TEWL values reflects an improvement in the barrier properties of the skin.	Baseline, Week 2 and Week 4
Secondary	Non-invasive Assessment: Skin pH	Skin pH measurements of defined target sites of the face will be reported.	Baseline, Week 2 and Week 4
Secondary	Non-invasive Assessment: Skin Hydration Measured by Corneometer	Skin hydration of defined target sites of face as measured by Corneometer will be reported. An increase in values reflects an improvement in the hydration of the skin.	Baseline, Week 2 and Week 4
Secondary	Non-invasive Assessment: Biomarker Tapes	Three D-squame tape strips will be taken from a defined target site on the face. D-Squame Standard Sampling Discs (CuDerm Corporation, Dallas, N) will be used to non-invasively collect skin samples from the forehead. The discs are 2.2 centimeters (cm) in diameter and have a homogenous layer of a medical-grade adhesive, which safely removes stratum corneum components and provides optimum visibility of adhering corneocytes. Samples will be collected for the analysis of various skin biomarkers such as skin flakiness, as well as the integrity of the natural moisturizing factors (NMFs), ceramides, free fatty acids, cholesterol via biochemical assays.	Baseline, Week 2 and Week 4
Secondary	Non-invasive Assessment: Facial Swabbing	A swabbing technique will be used to collect surface skin microflora to determine the effect of the non-marketed cosmetic facial cleanser on the skin microflora.	Baseline, Week 2 and Week 4

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