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

Completed · Not applicable

Conditions studied: Microbiota

In brief

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.

Key facts

Study ID

NCT03673059

Run by

Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.

People needed

91

Starts

2015-03-27

Expected to finish

2016-06-13

Last updated by the study team

2018-09-17

Who can join

Age: 16 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Thomas J. Stephens & Associates, Inc. — Colorado Springs, Colorado, United States
• Thomas J. Stephens and Associates, Inc. — Richardson, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.