NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

CompletedNA

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

Conditions: Microbiota

Interventions: OTC Eczema Moisturizer Regimen, Cosmetic Moisturizer Regimen

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 16 Years to 50 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (2)

Colorado Springs, Colorado, United States
Richardson, Texas, United States