Clinical Trial to Assess the Effects of Topical Lotions on Changes in the Skin Microbiome and Associations With Itch

Launched by JOHNSON & JOHNSON CONSUMER PRODUCTS COMPANY DIVISION OF JOHNSON & JOHNSON CONSUMER COMPANIES, INC. · Sep 13, 2018

Keywords

ClinConnect Summary

In this study, subjects were divided into two groups, one group was supplied with a test product containing an over-the-counter (OTC) drug monographed ingredient for treatment of eczema. The other group was supplied with a cosmetic test product which is a standard dry skin daily moisturizer. Both groups were also provided with a cosmetic test cleanser to use in place of their normal cleanser. Subjects used the products for 14 days, followed by a 7-day regression period (no product use).

Subjects were assessed at Baseline and at Day 1, Day 3, Day 7, and Day 14 of product use. They were asse...

Gender

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Eligibility criteria

• Inclusion Criteria:
• • Mild to moderate eczema, as determined by the investigator (score of 2.0-7.5 on Rajka-Langeland severity index).
• • Has 1 target lesion, as determined by the investigator (score of 6-12 on Atopic Dermatitis Severity Index (ADSI) and sub-score of at least 2 on erythema and pruritus).
• • Experienced a recent itch flare up and is experiencing pre-flare up symptoms at screening.
• • Did not use moisturizer on the face and body for 3 days prior to screening.
• • Has a score of at least 4.0 on Visual Analog Scale (VAS) Itch Assessment scale at baseline.
• • Generally in good health.
• • Willing to stop using all topical emollients, moisturizers, and/or other skin barrier creams and/or emulsion treatments for the eczema condition during the test period.
• • Willing and able to follow all study directions, including avoiding excessive sun exposure (including tanning beds), and to commit to all follow up visits for the duration of the study.
• • Completed informed consent/assent process and signed photograph release.
• • Must agree to practice a medically acceptable form of birth control.
• Exclusion Criteria:
• • Known allergies or sensitivities to test product ingredients.
• • Severe eczema.
• • Using a therapeutic (over the counter or prescription) body wash that contains an active ingredient for eczema.
• • Has a health condition or skin condition that the study investigator thinks could increase risk to the subject or confuse study results (e.g. immune deficiency disorders).
• • Has been using that the study investigator thinks could increase risk to the subject or confuse study results (e.g. corticosteroids, immunosuppressive medications).
• • Currently participating in another study.
• • Subjects who have clinically active bacterial, fungal, or viral skin infections or those who are susceptible to cutaneous infections.
• • Has any planned surgery and/or invasive medical procedures scheduled during the course of the study.