Clinical Trial: A Study to Evaluate the Tolerance of an Acne Treatment in Sensitive Skin Subjects With Mild to Moderate Acne Vulgaris

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Single Center Clinical Study to Evaluate the Tolerance of an Acne Treatment in Sensitive Skin Subjects With Mild to Moderate Acne Vulgaris

Brief Summary: The study will look to evaluate the tolerance of a light therapy-based acne mask device in participants who report having sensitive skin. All participants will receive a cleanser, a light therapy mask, and an extra activator for the light therapy mask.

Detailed Summary:

Acne and sensitive skin can be closely connected due to the reported involvement of an impaired skin barrier in both conditions, which can be further aggravated by potentially irritating topical treatments.

A patient's sensitive skin may be caused by the skincare products that they are using, the amount that they are applying (over-usage), or the concomitant effect of the different products being used, as well as by underlying medical conditions. While sensitive skin can be self-perceived and sometimes clinically apparent, as there is no agreed upon medical definition of 'sensitive skin', it is a 'diagnosis' primarily made by the patient's perception. The high incidence of this problem and potential for further irritation due to current topical treatments has left many patients in need of a sensitive skin solution for their acne.

Current at-home topical treatments for mild to moderate acne include Over-the-Counter (OTC) options, primarily with either benzoyl peroxide, or salicylic acid, as well as prescription options including retinoid-based products, however the cutaneous irritation potential of topical acne active ingredients has been reported in the literature, which is not desirable in particular for patients with sensitive skin.

Research has shown the benefits of red and blue light therapy in the treatment of mild to moderate acne, with blue light reported to target acne-causing bacteria and red light demonstrating anti-inflammatory activity. Previous studies with these types of modalities have shown high tolerance and efficacy. This study will look to evaluate the tolerance of a light therapy-based medical device in patients with self-reported sensitive skin.


Sponsor: Johnson & Johnson Consumer Inc. (J&JCI)

Current Primary Outcome:

  • Cutaneous Tolerance Scores: Erythema [ Time Frame: Baseline to Day 28 ]
    Percent mean change from baseline in erythema scores at Day 28. Scoring from "0" to "3", where "0" = "No erythema/redness of the treatment area" and "3" = "Marked erythema/redness of the treatment area"
  • Cutaneous Tolerance Scores: Dryness/Scaling [ Time Frame: Baseline to Day 28 ]
    Percent mean change from baseline in dryness/scaling scores at Day 28. Scoring from "0" to "3", where "0" = "No dryness of the treatment area" and "3" = "Marked dryness of the treatment area"
  • Cutaneous Tolerance Scores: Edema [ Time Frame: Baseline to Day 28 ]
    Percent mean change from baseline in edema scores at Day 28. Scoring from "0" to "3", where "0" = "No edema/swelling of the treatment area" and "3" = "Marked edema of the treatment area"
  • Cutaneous Tolerance Scores: Burning/Stinging [ Time Frame: Baseline to Day 28 ]
    Percent mean change from baseline in burning/stinging scores at Day 28. Scoring from "0" to "3", where "0" = " No burning/stinging of the treatment area" and "3" = " Hot burning/marked stinging sensation of the treatment area that causes definite discomfort and may interrupt daily activities and/or sleep"
  • Cutaneous Tolerance Scores: Itching [ Time Frame: Baseline to Day

    Original Primary Outcome:

    • Cutaneous Tolerance Scores: Erythema [ Time Frame: Baseline to Day 14 ]
      Percent mean change from baseline in erythema scores at Day 14. Scoring from "0" to "3", where "0" = "No erythema/redness of the treatment area" and "3" = "Marked erythema/redness of the treatment area"
    • Cutaneous Tolerance Scores: Dryness/Scaling [ Time Frame: Baseline to Day 14 ]
      Percent mean change from baseline in dryness/scaling scores at Day 14. Scoring from "0" to "3", where "0" = "No dryness of the treatment area" and "3" = "Marked dryness of the treatment area"
    • Cutaneous Tolerance Scores: Edema [ Time Frame: Baseline to Day 14 ]
      Percent mean change from baseline in edema scores at Day 14. Scoring from "0" to "3", where "0" = "No edema/swelling of the treatment area" and "3" = "Marked edema of the treatment area"
    • Cutaneous Tolerance Scores: Erythema [ Time Frame: Baseline to Day 28 ]
      Percent mean change from baseline in erythema scores at Day 28. Scoring from "0" to "3", where "0" = "No erythema/redness of the treatment area" and "3" = "Marked erythema/redness of the treatment area"
    • Cutaneous Tolerance Scores: Dryness/Scaling [ Time Frame: Baseline to Day 28 ]
      Percent mean change from baseline in dryness/scali

      Current Secondary Outcome:

      • Cutaneous Tolerance Scores: Erythema [ Time Frame: Time Frame: Baseline to Day 14 ]
        Percent mean change from baseline in erythema scores at Day 14. Scoring from "0" to "3", where "0" = "No erythema/redness of the treatment area" and "3" = "Marked erythema/redness of the treatment area"
      • Cutaneous Tolerance Scores: Dryness/Scaling [ Time Frame: Time Frame: Baseline to Day 14 ]
        Percent mean change from baseline in dryness/scaling scores at Day 14. Scoring from "0" to "3", where "0" = "No dryness of the treatment area" and "3" = "Marked dryness of the treatment area"
      • Cutaneous Tolerance Scores: Edema [ Time Frame: Time Frame: Baseline to Day 14 ]
        Percent mean change from baseline in edema scores at Day 14. Scoring from "0" to "3", where "0" = "No edema/swelling of the treatment area" and "3" = "Marked edema of the treatment area"
      • Cutaneous Tolerance Scores: Burning/Stinging [ Time Frame: Time Frame: Baseline to Day 14 ]
        Percent mean change from baseline in burning/stinging scores at Day 14. Scoring from "0" to "3", where "0" = " No burning/stinging of the treatment area" and "3" = " Hot burning/marked stinging sensation of the treatment area that causes definite discomfort and may interrupt daily activities and/or sleep"
      • Cutaneous Tolerance Scores: Itching [ Time Frame: Time Frame: Baseline to Day 14 ]
        Percent mean change from baseline in itching scores at Day 14. Scoring from "0" to "3", where "0" = " No itching of the treatment area" and "3" = "Marked itching sensation of the treatment area that causes definite discomfort and may interrupt daily activities and/or sleep"
      • Cutaneous Tolerance Scores: Tightness/Dry Feeling [ Time Frame: Time Frame: Baseline to Day 14 ]
        Percent mean change from baseline in tightness/dry feeling at Day 14. Scoring from "0" to "3", where "0" = "No skin tightness or dry feeling of the treatment area" and "3" = " Marked tightness or dry feeling of the treatment area that causes definite discomfort"


      Original Secondary Outcome:

      • Self-Assessment Questionnaire Binomial Test-Question: "Leaves my skin feeling comfortable" [ Time Frame: Day 14 ]
        Percent of favorable responses vs unfavorable responses at Day 14. Scoring from "1" to "5", where "1" = "Disagree Completely" and "5" = "Agree Completely"
      • Self-Assessment Questionnaire Binomial Test-Question: " Skin is not left feeling dry" [ Time Frame: Day 14 ]
        Percent of favorable responses vs unfavorable responses at Day 14. Scoring from "1" to "5", where "1" = "Disagree Completely" and "5" = "Agree Completely"
      • Self-Assessment Questionnaire Binomial Test-Question: " Skin is not left feeling tight or uncomfortable" [ Time Frame: Day 14 ]
        Percent of favorable responses vs unfavorable responses at Day 14. Scoring from "1" to "5", where "1" = "Disagree Completely" and "5" = "Agree Completely"
      • Self-Assessment Questionnaire Binomial Test-Question: " Skin does not look flaky" [ Time Frame: Day 14 ]
        Percent of favorable responses vs unfavorable responses at Day 14. Scoring from "1" to "5", where "1" = "Disagree Completely" and "5" = "Agree Completely"
      • Self-Assessment Questionnaire Binomial Test-Question: " Is gentle to skin" [ Time Frame: Day 14 ]
        Percent of favorable responses vs unfavorable responses at Day 14. Scoring from "1" to "5", where "1" = "Disagree Completely" and "5" = "Agree Completely"
      • Self-Assessment Questionnaire Binomial Test-Question: " Based on your experience of this light therapy mask, if you could, would you buy the product to continue the treatment?" [ Time Frame: Day 14 ]
        Percent of favorable responses vs unfavorable responses at Day 14. Scoring from "1" to "5", where "1" = "Disagree Completely" and "5" = "Agree Completely"
      • Self-Assessment Questionnaire Binomial Test-Question: " After this experience, I'm more likely to seek out light based skin therapies" [ Time Frame: Day 14 ]
        Percent of favorable responses vs unfavorable responses at Day 14. Scoring from "1" to "5", where "1" = "Disagree Completely" and "5" = "Agree Completely"
      • Self-Assessment Questionnaire Binomial Test-Question: "Leaves my skin feeling comfortable" [ Time Frame: Day 28 ]
        Percent of favorable responses vs unfavorable responses at Day 28. Scoring from "1" to "5", where "1" = "Disagree Completely" and "5" = "Agree Completely"
      • Self-Assessment Questionnaire Binomial Test-Question: " Skin is not left feeling dry" [ Time Frame: Day 28 ]
        Percent of favorable responses vs unfavorable responses at Day 28. Scoring from "1" to "5", where "1" = "Disagree Completely" and "5" = "Agree Completely"
      • Self-Assessment Questionnaire Binomial Test-Question: " Skin is not left feeling tight or uncomfortable" [ Time Frame: Day 28 ]
        Percent of favorable responses vs unfavorable responses at Day 28. Scoring from "1" to "5", where "1" = "Disagree Completely" and "5" = "Agree Completely"
      • Self-Assessment Questionnaire Binomial Test-Question: " Skin does not look flaky" [ Time Frame: Day 28 ]
        Percent of favorable responses vs unfavorable responses at Day 28. Scoring from "1" to "5", where "1" = "Disagree Completely" and "5" = "Agree Completely"
      • Self-Assessment Questionnaire Binomial Test-Question: " Is gentle to skin" [ Time Frame: Day 28 ]
        Percent of favorable responses vs unfavorable responses at Day 28. Scoring from "1" to "5", where "1" = "Disagree Completely" and "5" = "Agree Completely"
      • Self-Assessment Questionnaire Binomial Test-Question: " Based on your experience of this light therapy mask, if you could, would you buy the product to continue the treatment?" [ Time Frame: Day 28 ]
        Percent of favorable responses vs unfavorable responses at Day 28. Scoring from "1" to "5", where "1" = "Disagree Completely" and "5" = "Agree Completely"

      • Information By: Johnson & Johnson Consumer and Personal Products Worldwide

        Dates:
        Date Received: April 20, 2017
        Date Started: April 4, 2017
        Date Completion: June 2017
        Last Updated: May 12, 2017
        Last Verified: May 2017