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

NCT03673059 | Completed

• 1 other identifier: PS-141014142040-THCT
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 2

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.

Conditions

Microbiota

Keywords

Microbiome; Eczema; Itching; Quality of life; Moisturization

Outcome Measures

Primary Outcomes (1)

• Microbiome Composition Changes in Lesion Skin - Baseline to Day 14

  Changes in the composition (abundance and diversity) of the microbiome communities present on the lesional skin from Baseline to Day 14. The microbiome of the skin of interest was sampled using a sterile swab, sequenced to amplify genomic regions, and analyzed using standard protocols to determine associated organisms, both known and novel, between the two time points.

  2 weeks

Secondary Outcomes (29)

• Microbiome Composition Changes in Lesion Skin - Baseline to Day 7

  1 week

• Microbiome Composition Changes in Lesion Skin - Baseline to Day 3

  3 days

• Microbiome Composition Changes in Lesion Skin - Baseline to Day 1

  1 day

• Microbiome Composition Changes in Lesion Skin - Regression Baseline to Day Regression Day 7

  1 week

• Skin pH - Change - Baseline to Day 14

  2 weeks

Study Arms (2)

OTC Eczema Moisturizer Regimen

EXPERIMENTAL

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.

Drug: OTC Eczema Moisturizer Regimen

Cosmetic Moisturizer Regimen

EXPERIMENTAL

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

Other: Cosmetic Moisturizer Regimen

Interventions

OTC Eczema Moisturizer Regimen DRUG

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.

Also known as: Group A

OTC Eczema Moisturizer Regimen

Cosmetic Moisturizer Regimen OTHER

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.

Also known as: Group B

Cosmetic Moisturizer Regimen

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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.

Sponsors & Collaborators

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

Study Sites (2)

Thomas J. Stephens & Associates, Inc.

Colorado Springs, Colorado, 80915, United States

Location

Thomas J. Stephens and Associates, Inc.

Richardson, Texas, 75081, United States

Location

Related Publications (7)

• Phan NQ, Blome C, Fritz F, Gerss J, Reich A, Ebata T, Augustin M, Szepietowski JC, Stander S. Assessment of pruritus intensity: prospective study on validity and reliability of the visual analogue scale, numerical rating scale and verbal rating scale in 471 patients with chronic pruritus. Acta Derm Venereol. 2012 Sep;92(5):502-7. doi: 10.2340/00015555-1246.

  PMID: 22170091 BACKGROUND

• 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.

  PMID: 18550210 BACKGROUND

• 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.

  PMID: 17903619 BACKGROUND

• 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.

  PMID: 19995367 BACKGROUND

• 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.

  PMID: 22310478 BACKGROUND

• Rajka G, Langeland T. Grading of the severity of atopic dermatitis. Acta Derm Venereol Suppl (Stockh). 1989;144:13-4. doi: 10.2340/000155551441314.

  PMID: 2800895 BACKGROUND

• 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.

  PMID: 11168575 BACKGROUND

MeSH Terms

Conditions

Eczema; Pruritus

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lily Jiang, Ph.D.

  Thomas J. Stephens & Associates, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 17, 2018
• First Posted: September 17, 2018
• Study Start: March 27, 2015
• Primary Completion: June 13, 2016
• Study Completion: June 13, 2016
• Last Updated: September 17, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)