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

NCT ID: NCT03673059

Last Updated: 2018-09-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-27
• Study Completion Date: 2016-06-13

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.

Conditions

Microbiota

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

OTC Eczema Moisturizer Regimen

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.

Group Type: EXPERIMENTAL

OTC Eczema Moisturizer Regimen

Intervention Type: 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.

Cosmetic Moisturizer Regimen

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

Group Type: EXPERIMENTAL

Cosmetic Moisturizer Regimen

Intervention Type: 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.

Interventions

OTC Eczema Moisturizer Regimen

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.

Intervention Type: DRUG

Cosmetic Moisturizer Regimen

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.

Intervention Type: OTHER

Other Intervention Names

Group A; Group B

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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lily Jiang, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Thomas J. Stephens & Associates, Inc.

Locations

Thomas J. Stephens & Associates, Inc.

Colorado Springs, Colorado, United States

Thomas J. Stephens and Associates, Inc.

Richardson, Texas, United States

Countries

United States

References

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Reference Type: BACKGROUND

PMID: 22170091 (View on PubMed)

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.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 17903619 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19995367 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 22310478 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 2800895 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11168575 (View on PubMed)

Other Identifiers

PS-141014142040-THCT

Identifier Type: -

Identifier Source: org_study_id