Clinical trial NCT03673059: Clinical Trial to Assess the Effects of Topical Lotions on Changes in the Skin Microbiome and Associations With Itch
Official title: A Multi-Center, Controlled Clinical Trial to Assess the Effects of Topical Lotions on Changes in the Skin Microbiome and Associations With Itch
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Microbiota
Keywords: Microbiome
Eczema
Itching
Quality of life
Moisturization
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2018-09-17
Enrollment: 91
Sex: ALL
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: BASIC_SCIENCE

Brief 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.

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.

Primary outcomes:
measure: Microbiome Composition Changes in Lesion Skin - Baseline to Day 14
timeFrame: 2 weeks
Secondary outcomes:
measure: Microbiome Composition Changes in Lesion Skin - Baseline to Day 7
timeFrame: 1 week
measure: Microbiome Composition Changes in Lesion Skin - Baseline to Day 3
timeFrame: 3 days
measure: Microbiome Composition Changes in Lesion Skin - Baseline to Day 1
timeFrame: 1 day
measure: Microbiome Composition Changes in Lesion Skin - Regression Baseline to Day Regression Day 7
timeFrame: 1 week
measure: Skin pH - Change - Baseline to Day 14
timeFrame: 2 weeks
measure: Skin pH - Change - Baseline to Day 7
timeFrame: 1 week
measure: Skin pH - Change - Baseline to Day 3
timeFrame: 3 days
measure: Skin pH - Change - Baseline to Day 1
timeFrame: 1 day
measure: Skin pH - Change - Regression Baseline to Regression Day 7
timeFrame: 1 week
measure: Skin Transepidermal Water Loss (TEWL) - Change - Baseline to Day 14
timeFrame: 2 weeks
measure: Skin Transepidermal Water Loss (TEWL) - Change - Baseline to Day 7
timeFrame: 1 week
measure: Skin Transepidermal Water Loss (TEWL) - Change - Baseline to Day 3
timeFrame: 3 days
measure: Skin Transepidermal Water Loss (TEWL) - Change - Baseline to Day 1
timeFrame: 1 day
measure: Skin Transepidermal Water Loss (TEWL) - Change - Regression Baseline to Regression Day 7
timeFrame: 1 week
measure: Skin Hydration - Change - Baseline to Day 14
timeFrame: 2 weeks
measure: Skin Hydration - Change - Baseline to Day 7
timeFrame: 1 week
measure: Skin Hydration - Change - Baseline to Day 3
timeFrame: 3 days
measure: Skin Hydration - Change - Baseline to Day 1
timeFrame: 1 day
measure: Skin Hydration - Change - Regression Baseline (Day 14) to Regression Day 7 (Day 21)
timeFrame: 1 week
measure: Eczema Area Severity Index (EASI) - Change - Baseline to Day 14
timeFrame: 2 weeks
measure: Eczema Area Severity Index (EASI) - Change - Baseline to Day 7
timeFrame: 1 week
measure: Eczema Area Severity Index (EASI) - Change - Baseline to Day 3
timeFrame: 3 days
measure: Eczema Area Severity Index (EASI) - Change - Baseline to Day 1
timeFrame: 1 day
measure: Eczema Area Severity Index (EASI) - Change - Regression Baseline to Regression Day 7
timeFrame: 1 week
measure: Atopic Dermatitis Severity Index (ADSI) - Change - Baseline to Day 14
timeFrame: 2 weeks
measure: Atopic Dermatitis Severity Index (ADSI) - Change - Baseline to Day 7
timeFrame: 1 week
measure: Atopic Dermatitis Severity Index (ADSI) - Change - Baseline to Day 3
timeFrame: 3 days
measure: Atopic Dermatitis Severity Index (ADSI) - Change - Baseline to Day 1
timeFrame: 1 day
measure: Atopic Dermatitis Severity Index (ADSI) - Change - Regression Baseline to Regression Day 7
timeFrame: 1 week
Other outcomes:
Locations:
city: Colorado Springs
country: United States
facility: Thomas J. Stephens & Associates, Inc.
state: Colorado
city: Richardson
country: United States
facility: Thomas J. Stephens and Associates, Inc.
state: Texas
Study officials:
affiliation: Thomas J. Stephens & Associates, Inc.
name: Lily Jiang, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Desai NS, Poindexter GB, Monthrope YM, Bendeck SE, Swerlick RA, Chen SC. A pilot quality-of-life instrument for pruritus. J Am Acad Dermatol. 2008 Aug;59(2):234-44. doi: 10.1016/j.jaad.2008.04.006. Epub 2008 Jun 11.
citation: Lipozencic J, Wolf R. Atopic dermatitis: an update and review of the literature. Dermatol Clin. 2007 Oct;25(4):605-12, x. doi: 10.1016/j.det.2007.06.009.
citation: Elman S, Hynan LS, Gabriel V, Mayo MJ. The 5-D itch scale: a new measure of pruritus. Br J Dermatol. 2010 Mar;162(3):587-93. doi: 10.1111/j.1365-2133.2009.09586.x. Epub 2009 Dec 1.
citation: Kong HH, Oh J, Deming C, Conlan S, Grice EA, Beatson MA, Nomicos E, Polley EC, Komarow HD; NISC Comparative Sequence Program; Murray PR, Turner ML, Segre JA. Temporal shifts in the skin microbiome associated with disease flares and treatment in children with atopic dermatitis. Genome Res. 2012 May;22(5):850-9. doi: 10.1101/gr.131029.111. Epub 2012 Feb 6.
citation: Rajka G, Langeland T. Grading of the severity of atopic dermatitis. Acta Derm Venereol Suppl (Stockh). 1989;144:13-4. doi: 10.2340/000155551441314.
citation: Hanifin JM, Thurston M, Omoto M, Cherill R, Tofte SJ, Graeber M. The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. EASI Evaluator Group. Exp Dermatol. 2001 Feb;10(1):11-8. doi: 10.1034/j.1600-0625.2001.100102.x.