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

Johnson & Johnson (J&J)

Status: Completed

Conditions: Microbiota

Treatments: Drug: OTC Eczema Moisturizer Regimen; Other: Cosmetic Moisturizer Regimen

Study type: Interventional

Funder types: Industry

Identifiers

NCT03673059

PS-141014142040-THCT

Details and patient eligibility

About

This was a multi-center, 14-day clinical use study with a 7-day regression period, being conducted to assess the changes in the skin microbiome with two moisturizers in female and male subjects 16-50 years of age with mild to moderate eczema that experienced a recent itch flare up.

Full description

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 assessed again 7 days after stopping product use. Only the group provided with the test product containing the monograph ingredient for treatment of eczema were assessed for eczema endpoints after the Baseline visit.

Enrollment: 91 patients

Sex: All

Ages: 16 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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91 participants in 2 patient groups

OTC Eczema Moisturizer Regimen

Experimental group

Description:

Subjects who were assigned to use an over-the-counter (OTC), oatmeal-containing eczema therapy moisturizing cream. The product is classified as an OTC monograph drug.

Treatment:

Drug: OTC Eczema Moisturizer Regimen

Cosmetic Moisturizer Regimen

Experimental group

Description:

Subjects who were assigned to use a non-fragranced, dry skin daily moisturizer classified as a cosmetic (i.e. non-OTC).

Treatment:

Other: Cosmetic Moisturizer Regimen