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

Primary Purpose

Dermatitis, Atopic, Rosacea, Acne Vulgaris

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Non-marketed Cosmetic Facial Cleanser
Sponsored by
Johnson & Johnson Consumer Inc. (J&JCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Dermatitis, Atopic

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Dermatology Consulting Services, PLLC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Non-marketed Cosmetic Facial Cleanser

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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).
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).
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).
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.
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.
Non-invasive Assessment: Skin pH
Skin pH measurements of defined target sites of the face will be reported.
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.
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.
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.

Full Information

First Posted
October 13, 2021
Last Updated
November 18, 2022
Sponsor
Johnson & Johnson Consumer Inc. (J&JCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05094700
Brief Title
A Study of a Polymeric Surfactant Technology Cleanser in Sensitive Skin Participants
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
October 25, 2021 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
November 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Consumer Inc. (J&JCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis, Atopic, Rosacea, Acne Vulgaris, Sensitive Skin

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non-marketed Cosmetic Facial Cleanser
Arm Type
Experimental
Arm Description
Participants will receive non-marketed cosmetic facial cleanser to apply on cleanse facial skin, twice daily for 4 weeks.
Intervention Type
Other
Intervention Name(s)
Non-marketed Cosmetic Facial Cleanser
Intervention Description
Participants will apply non-marketed cosmetic facial cleanser on cleanse facial skin, twice daily for 4 weeks.
Primary Outcome Measure Information:
Title
Mildness of the Facial Cleanser in Participants with Sensitive Skin Based on Investigator and Participant Assessments
Description
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.
Time Frame
Baseline to Week 4
Secondary Outcome Measure Information:
Title
Investigator Assessment for Tolerability
Description
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).
Time Frame
Baseline, Week 2 and Week 4
Title
Investigator Assessment for Efficacy
Description
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).
Time Frame
Baseline, Week 2 and Week 4
Title
Participant Assessment for Tolerability
Description
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).
Time Frame
Baseline, Week 2 and Week 4
Title
Participant Assessment for Efficacy
Description
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).
Time Frame
Baseline, Week 2 and Week 4
Title
Photographic Imaging (Right, Left and Frontal Face with Standard Lighting 1 and Cross Polarized Light)
Description
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.
Time Frame
Baseline, Week 2 and Week 4
Title
Non-invasive Assessment: Transepidermal Water Loss (TEWL)
Description
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.
Time Frame
Baseline, Week 2 and Week 4
Title
Non-invasive Assessment: Skin pH
Description
Skin pH measurements of defined target sites of the face will be reported.
Time Frame
Baseline, Week 2 and Week 4
Title
Non-invasive Assessment: Skin Hydration Measured by Corneometer
Description
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.
Time Frame
Baseline, Week 2 and Week 4
Title
Non-invasive Assessment: Biomarker Tapes
Description
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.
Time Frame
Baseline, Week 2 and Week 4
Title
Non-invasive Assessment: Facial Swabbing
Description
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.
Time Frame
Baseline, Week 2 and Week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zoe Diana Draelos, MD
Organizational Affiliation
Dermatology Consulting Services, PLLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dermatology Consulting Services, PLLC
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Johnson & Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.
IPD Sharing URL
http://yoda.yale.edu
Citations:
PubMed Identifier
3377516
Citation
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.
Results Reference
background
Citation
U.S. Census Bureau. (n.d.). About race. Retrieved July 27, 2021, from https://www.census.gov/topics/population/race/about.html
Results Reference
background
Citation
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
Results Reference
background
Links:
URL
https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217051&parentIdentifier=CCSSKA004090&attachmentIdentifier=da2bc3db-39e3-4e8b-9c42-c66815e9ac6e&fileName=Summary_CSR_for_ClinTrials.gov_Posting.Pivotal.18NOV2022.pdf&versionIdentifier=
Description
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A Study of a Polymeric Surfactant Technology Cleanser in Sensitive Skin Participants

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