Clinical Trial to Assess the Effects of Topical Lotions on Changes in the Skin Microbiome and Associations With Itch
Condition: Microbiota
Study type: Interventional

Summary: 
      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.
    

Detailed 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.
    

Intervention name(s): OTC Eczema Moisturizer Regimen; Cosmetic Moisturizer Regimen
Intervention type(s): Drug; Other
Intervention description(s): Subjects were assigned to use an OTC, oatmeal-containing eczema therapy moisturizing cream twice daily on their face and entire body for the 14-day treatment period of the study, in place of any other moisturizers/emollients. Subjects were also provided with a mild cleanser to use in place of their normal body wash and/or soap (same cleanser as used by Group B) per their usual cleansing routine. After the 14-day treatment period, subjects discontinued use of the moisturizer for the 7-day regression period.; Subjects were assigned to use a non-fragranced, dry skin daily moisturizer twice daily on their face and entire body for the 14-day treatment period of the study, in place of any other moisturizers/emollients. Subjects were also provided with a mild cleanser to use in place of their normal body wash and/or soap (same cleanser as used by Group A) per their usual cleansing routine. After the 14-day treatment period, subjects discontinued use of the moisturizer for the 7-day regression period.
Other intervention name(s): Group A; Group B
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects were randomly assigned to two groups. One group was supplied with a test product containing an OTC drug monographed ingredient for treatment of eczema and 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. There was a 7-day regression period following the 14 days of product use.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Microbiome; Eczema; Itching; Quality of life; Moisturization