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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Multi-Center, Controlled Clinical Trial to Assess the Effects of Topical Lotions on Changes in the Skin Microbiome and Associations With Itch

Conditions
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Microbiota

Intervention / Treatment
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* Drug: OTC Eczema Moisturizer Regimen
* Other: Cosmetic Moisturizer Regimen


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OTC Eczema Moisturizer Regimen<br>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<br>* 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.<br>* Other names: Group A;|
| Experimental: Cosmetic Moisturizer Regimen<br>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<br>* 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.<br>* Other names: Group B;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiome Composition Changes in Lesion Skin - Baseline to Day 7 | Changes in the composition (abundance and diversity) of the microbiome communities present on the lesional skin from Baseline to Day 7. 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. | 1 week | 
| Microbiome Composition Changes in Lesion Skin - Baseline to Day 3 | Changes in the composition (abundance and diversity) of the microbiome communities present on the lesional skin from Baseline to Day 3. 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. | 3 days | 
| Microbiome Composition Changes in Lesion Skin - Baseline to Day 1 | Changes in the composition (abundance and diversity) of the microbiome communities present on the lesional skin from Baseline to Day 1. 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. | 1 day | 
| Microbiome Composition Changes in Lesion Skin - Regression Baseline to Day Regression Day 7 | Changes in the composition (abundance and diversity) of the microbiome communities present on the lesional skin from Regression Baseline (Study Day 14) to Regression Day 7 (Study Day 21). 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. | 1 week | 
| Skin pH - Change - Baseline to Day 14 | Change from baseline in pH of lesional skin at Day 14. | 2 weeks | 
| Skin pH - Change - Baseline to Day 7 | Change from baseline in pH of lesional skin at Day 7. | 1 week | 
| Skin pH - Change - Baseline to Day 3 | Change from baseline in pH of lesional skin at Day 3. | 3 days | 
| Skin pH - Change - Baseline to Day 1 | Change from baseline in pH of lesional skin at Day 1. | 1 day | 
| Skin pH - Change - Regression Baseline to Regression Day 7 | Change from regression baseline (Study Day 14) in pH of lesion skin at Regression Day 7 (Study Day 21). | 1 week | 
| Skin Transepidermal Water Loss (TEWL) - Change - Baseline to Day 14 | Change from baseline in TEWL of lesional skin at Day 14. | 2 weeks | 
| Skin Transepidermal Water Loss (TEWL) - Change - Baseline to Day 7 | Change from baseline in TEWL of lesional skin at Day 7. | 1 week | 
| Skin Transepidermal Water Loss (TEWL) - Change - Baseline to Day 3 | Change from baseline in TEWL of lesional skin at Day 3. | 3 days | 
| Skin Transepidermal Water Loss (TEWL) - Change - Baseline to Day 1 | Change from baseline in TEWL of lesional skin at Day 1. | 1 day | 
| Skin Transepidermal Water Loss (TEWL) - Change - Regression Baseline to Regression Day 7 | Change from regression baseline (Study Day 14) in TEWL of lesional skin at Regression Day 7 (Study Day 21). | 1 week | 
| Skin Hydration - Change - Baseline to Day 14 | Change from baseline in Skin Hydration via conductance of lesional skin at Day 14. | 2 weeks | 
| Skin Hydration - Change - Baseline to Day 7 | Change from baseline in Skin Hydration via conductance of lesional skin at Day 7. | 1 week | 
| Skin Hydration - Change - Baseline to Day 3 | Change from baseline in Skin Hydration via conductance of lesional skin at Day 3. | 3 days | 
| Skin Hydration - Change - Baseline to Day 1 | Change from baseline in Skin Hydration via conductance of lesional skin at Day 1. | 1 day | 
| Skin Hydration - Change - Regression Baseline (Day 14) to Regression Day 7 (Day 21) | Change from regression baseline (Day 14) in Skin Hydration via conductance of lesional skin at Regression Day 7 (Day 21). | 1 week | 
| Eczema Area Severity Index (EASI) - Change - Baseline to Day 14 | Change from baseline in total EASI score at Day 14. Group A only. The EASI scoring system provides a score that reflects the severity of clinical signs of eczema based on the percentage of affected area in each of 4 body regions - the head/neck, trunk, upper extremities, and lower extremities. Each body region is scored for 4 parameters: erythema, edema, excoriations, and lichenification on a 0 (none) to 3 (severe) scale. The score for these parameters is summed and then multiplied by a constant that reflects the relative body area of that body region (head/neck = 0.10; trunk = 0.30; upper extremities = 0.20, lower extremities = 0.40). The total EASI score is calculated as a sum of the scores for the 4 individual body regions. The total possible score ranges from 0 (no eczema anywhere on the body) to 72 (severest eczema symptoms on all body areas). | 2 weeks | 
| Eczema Area Severity Index (EASI) - Change - Baseline to Day 7 | Change from baseline in total EASI score at Day 7. Group A only. The EASI scoring system provides a score that reflects the severity of clinical signs of eczema based on the percentage of affected area in each of 4 body regions - the head/neck, trunk, upper extremities, and lower extremities. Each body region is scored for 4 parameters: erythema, edema, excoriations, and lichenification on a 0 (none) to 3 (severe) scale. The score for these parameters is summed and then multiplied by a constant that reflects the relative body area of that body region (head/neck = 0.10; trunk = 0.30; upper extremities = 0.20, lower extremities = 0.40). The total EASI score is calculated as a sum of the scores for the 4 individual body regions. The total possible score ranges from 0 (no eczema anywhere on the body) to 72 (severest eczema symptoms on all body areas). | 1 week | 
| Eczema Area Severity Index (EASI) - Change - Baseline to Day 3 | Change from baseline in total EASI score at Day 3. Group A only. The EASI scoring system provides a score that reflects the severity of clinical signs of eczema based on the percentage of affected area in each of 4 body regions - the head/neck, trunk, upper extremities, and lower extremities. Each body region is scored for 4 parameters: erythema, edema, excoriations, and lichenification on a 0 (none) to 3 (severe) scale. The score for these parameters is summed and then multiplied by a constant that reflects the relative body area of that body region (head/neck = 0.10; trunk = 0.30; upper extremities = 0.20, lower extremities = 0.40). The total EASI score is calculated as a sum of the scores for the 4 individual body regions. The total possible score ranges from 0 (no eczema anywhere on the body) to 72 (severest eczema symptoms on all body areas). | 3 days | 
| Eczema Area Severity Index (EASI) - Change - Baseline to Day 1 | Change from baseline in total EASI score at Day 1. Group A only. The EASI scoring system provides a score that reflects the severity of clinical signs of eczema based on the percentage of affected area in each of 4 body regions - the head/neck, trunk, upper extremities, and lower extremities. Each body region is scored for 4 parameters: erythema, edema, excoriations, and lichenification on a 0 (none) to 3 (severe) scale. The score for these parameters is summed and then multiplied by a constant that reflects the relative body area of that body region (head/neck = 0.10; trunk = 0.30; upper extremities = 0.20, lower extremities = 0.40). The total EASI score is calculated as a sum of the scores for the 4 individual body regions. The total possible score ranges from 0 (no eczema anywhere on the body) to 72 (severest eczema symptoms on all body areas). | 1 day | 
| Eczema Area Severity Index (EASI) - Change - Regression Baseline to Regression Day 7 | Change from regression baseline (Study Day 14) in total EASI score at Regression Day 7 (Study Day 21). Group A only. The EASI scoring system provides a score that reflects the severity of clinical signs of eczema based on the percentage of affected area in each of 4 body regions - the head/neck, trunk, upper extremities, and lower extremities. Each body region is scored for 4 parameters: erythema, edema, excoriations, and lichenification on a 0 (none) to 3 (severe) scale. The score for these parameters is summed and then multiplied by a constant that reflects the relative body area of that body region (head/neck = 0.10; trunk = 0.30; upper extremities = 0.20, lower extremities = 0.40). The total EASI score is calculated as a sum of the scores for the 4 individual body regions. The total possible score ranges from 0 (no eczema anywhere on the body) to 72 (severest eczema symptoms on all body areas). | 1 week | 
| Atopic Dermatitis Severity Index (ADSI) - Change - Baseline to Day 14 | Change from baseline in total ADSI score at Day 14. Group A only. ADSI is a scoring system that reflects the severity of a target eczema lesion. The ADSI score is a sum of scores for 5 different parameters - erythema, itching, exudation, excoriation, lichenification - which are each measured on a 0 (none) to 3 (scale). The total score can range from 0 (no eczema signs) to 15 (very severe eczema lesion). | 2 weeks | 
| Atopic Dermatitis Severity Index (ADSI) - Change - Baseline to Day 7 | Change from baseline in total ADSI score at Day 7. Group A only. ADSI is a scoring system that reflects the severity of a target eczema lesion. The ADSI score is a sum of scores for 5 different parameters - erythema, itching, exudation, excoriation, lichenification - which are each measured on a 0 (none) to 3 (scale). The total score can range from 0 (no eczema signs) to 15 (very severe eczema lesion). | 1 week | 
| Atopic Dermatitis Severity Index (ADSI) - Change - Baseline to Day 3 | Change from baseline in total ADSI score at Day 3. Group A only. ADSI is a scoring system that reflects the severity of a target eczema lesion. The ADSI score is a sum of scores for 5 different parameters - erythema, itching, exudation, excoriation, lichenification - which are each measured on a 0 (none) to 3 (scale). The total score can range from 0 (no eczema signs) to 15 (very severe eczema lesion). | 3 days | 
| Atopic Dermatitis Severity Index (ADSI) - Change - Baseline to Day 1 | Change from baseline in total ADSI score at Day 1. Group A only. ADSI is a scoring system that reflects the severity of a target eczema lesion. The ADSI score is a sum of scores for 5 different parameters - erythema, itching, exudation, excoriation, lichenification - which are each measured on a 0 (none) to 3 (scale). The total score can range from 0 (no eczema signs) to 15 (very severe eczema lesion). | 1 day | 
| Atopic Dermatitis Severity Index (ADSI) - Change - Regression Baseline to Regression Day 7 | Change from regression baseline (Study Day 14) in total ADSI score at Regression Day 7 (Study Day 21). Group A only. ADSI is a scoring system that reflects the severity of a target eczema lesion. The ADSI score is a sum of scores for 5 different parameters - erythema, itching, exudation, excoriation, lichenification - which are each measured on a 0 (none) to 3 (scale). The total score can range from 0 (no eczema signs) to 15 (very severe eczema lesion). | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Microbiome, Eczema, Itching, Quality of life, Moisturization