MicrobiotaNCT03673059
Clinical Trial to Assess the Effects of Topical Lotions on Changes in the Skin Microbiome and Associations With Itch
A study testing OTC Eczema Moisturizer Regimen and Cosmetic Moisturizer Regimen in people with Microbiota, run by Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 50 years
- Conditions the study is for
- Microbiota
- What is being tested?
- OTC Eczema Moisturizer Regimen and Cosmetic Moisturizer Regimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Mar 2015to 13 Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Thomas J. Stephens & Associates, Inc.
Colorado Springs, Colorado, 80915
Thomas J. Stephens and Associates, Inc.
Richardson, Texas, 75081
About this study
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
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.
Read the 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
- Being tested
- OTC Eczema Moisturizer Regimen, Cosmetic Moisturizer Regimen
- Keywords
- Microbiome, Eczema, Itching, Quality of life, Moisturization
- Medical subject headings
- Eczema, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OTC Eczema Moisturizer RegimenDrug
Also called Group A
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 RegimenOther
Also called Group B
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Other: Cosmetic Moisturizer Regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks
Secondary outcomes (29)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 week
Skin pH - Change - Baseline to Day 14
Change from baseline in pH of lesional skin at Day 14.
Measured: 2 weeks
Skin pH - Change - Baseline to Day 7
Change from baseline in pH of lesional skin at Day 7.
Measured: 1 week
Skin pH - Change - Baseline to Day 3
Change from baseline in pH of lesional skin at Day 3.
Measured: 3 days
Skin pH - Change - Baseline to Day 1
Change from baseline in pH of lesional skin at Day 1.
Measured: 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).
Measured: 1 week
Skin Transepidermal Water Loss (TEWL) - Change - Baseline to Day 14
Change from baseline in TEWL of lesional skin at Day 14.
Measured: 2 weeks
Skin Transepidermal Water Loss (TEWL) - Change - Baseline to Day 7
Change from baseline in TEWL of lesional skin at Day 7.
Measured: 1 week
Skin Transepidermal Water Loss (TEWL) - Change - Baseline to Day 3
Change from baseline in TEWL of lesional skin at Day 3.
Measured: 3 days
Skin Transepidermal Water Loss (TEWL) - Change - Baseline to Day 1
Change from baseline in TEWL of lesional skin at Day 1.
Measured: 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).
Measured: 1 week
Skin Hydration - Change - Baseline to Day 14
Change from baseline in Skin Hydration via conductance of lesional skin at Day 14.
Measured: 2 weeks
Skin Hydration - Change - Baseline to Day 7
Change from baseline in Skin Hydration via conductance of lesional skin at Day 7.
Measured: 1 week
Skin Hydration - Change - Baseline to Day 3
Change from baseline in Skin Hydration via conductance of lesional skin at Day 3.
Measured: 3 days
Skin Hydration - Change - Baseline to Day 1
Change from baseline in Skin Hydration via conductance of lesional skin at Day 1.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start27 Mar 2015
- Primary completion13 Jun 2016
- Study completion13 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for MicrobiotaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lily Jiang, Ph.D., Principal investigator, Thomas J. Stephens & Associates, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03673059
- Sponsor's protocol ID
- PS-141014142040-THCT
- Status last verified
- Sep 2018
- First submitted
- 17 Aug 2018
- Last updated
- 17 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22170091Desai 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.
PubMed 18550210Lipozencic 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.
PubMed 17903619Elman 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.
PubMed 19995367Kong 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.
PubMed 22310478Rajka G, Langeland T. Grading of the severity of atopic dermatitis. Acta Derm Venereol Suppl (Stockh). 1989;144:13-4. doi: 10.2340/000155551441314.
PubMed 2800895Hanifin 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.
PubMed 11168575
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03673059
- Acronym / sponsor ID
- PS-141014142040-THCT
- Conditions
- Microbiota
- Keywords
- Microbiome, Eczema, Itching, Quality of life, Moisturization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Mar 2015 (actual)
- Primary completion
- 13 Jun 2016 (actual)
- Study completion
- 13 Jun 2016 (actual)
- First posted
- 17 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| OTC Eczema Moisturizer Regimen | Experimental | Drug: OTC Eczema Moisturizer RegimenSubjects 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. |
| Cosmetic Moisturizer Regimen | Experimental | Other: Cosmetic Moisturizer RegimenSubjects who were assigned to use a non-fragranced, dry skin daily moisturizer classified as a cosmetic (i.e. non-OTC). |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OTC Eczema Moisturizer RegimenAlso: Group ASubjects 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. | Drug | OTC Eczema Moisturizer Regimen |
| Cosmetic Moisturizer RegimenAlso: Group BSubjects 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 | Cosmetic Moisturizer Regimen |
Primary outcome
Microbiome Composition Changes in Lesion Skin - Baseline to Day 14
Time frame: 2 weeks
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.
29 secondary outcomes
Microbiome Composition Changes in Lesion Skin - Baseline to Day 7
Time frame: 1 week
Microbiome Composition Changes in Lesion Skin - Baseline to Day 3
Time frame: 3 days
Microbiome Composition Changes in Lesion Skin - Baseline to Day 1
Time frame: 1 day
Microbiome Composition Changes in Lesion Skin - Regression Baseline to Day Regression Day 7
Time frame: 1 week
Skin pH - Change - Baseline to Day 14
Time frame: 2 weeks
Skin pH - Change - Baseline to Day 7
Time frame: 1 week
Skin pH - Change - Baseline to Day 3
Time frame: 3 days
Skin pH - Change - Baseline to Day 1
Time frame: 1 day
Skin pH - Change - Regression Baseline to Regression Day 7
Time frame: 1 week
Skin Transepidermal Water Loss (TEWL) - Change - Baseline to Day 14
Time frame: 2 weeks
Skin Transepidermal Water Loss (TEWL) - Change - Baseline to Day 7
Time frame: 1 week
Skin Transepidermal Water Loss (TEWL) - Change - Baseline to Day 3
Time frame: 3 days
Skin Transepidermal Water Loss (TEWL) - Change - Baseline to Day 1
Time frame: 1 day
Skin Transepidermal Water Loss (TEWL) - Change - Regression Baseline to Regression Day 7
Time frame: 1 week
Skin Hydration - Change - Baseline to Day 14
Time frame: 2 weeks
Skin Hydration - Change - Baseline to Day 7
Time frame: 1 week
Skin Hydration - Change - Baseline to Day 3
Time frame: 3 days
Skin Hydration - Change - Baseline to Day 1
Time frame: 1 day
Skin Hydration - Change - Regression Baseline (Day 14) to Regression Day 7 (Day 21)
Time frame: 1 week
Eczema Area Severity Index (EASI) - Change - Baseline to Day 14
Time frame: 2 weeks
Eczema Area Severity Index (EASI) - Change - Baseline to Day 7
Time frame: 1 week
Eczema Area Severity Index (EASI) - Change - Baseline to Day 3
Time frame: 3 days
Eczema Area Severity Index (EASI) - Change - Baseline to Day 1
Time frame: 1 day
Eczema Area Severity Index (EASI) - Change - Regression Baseline to Regression Day 7
Time frame: 1 week
Atopic Dermatitis Severity Index (ADSI) - Change - Baseline to Day 14
Time frame: 2 weeks
Atopic Dermatitis Severity Index (ADSI) - Change - Baseline to Day 7
Time frame: 1 week
Atopic Dermatitis Severity Index (ADSI) - Change - Baseline to Day 3
Time frame: 3 days
Atopic Dermatitis Severity Index (ADSI) - Change - Baseline to Day 1
Time frame: 1 day
Atopic Dermatitis Severity Index (ADSI) - Change - Regression Baseline to Regression Day 7
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2018.
- Background: PubMed 22170091Phan 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.
- Background: PubMed 18550210Desai 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.
- Background: PubMed 17903619Lipozencic 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.
- Background: PubMed 19995367Elman 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.
- Background: PubMed 22310478Kong 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.
- Background: PubMed 2800895Rajka G, Langeland T. Grading of the severity of atopic dermatitis. Acta Derm Venereol Suppl (Stockh). 1989;144:13-4. doi: 10.2340/000155551441314.
- Background: PubMed 11168575Hanifin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lily Jiang, Ph.D. principal investigator
Thomas J. Stephens & Associates, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OTC Eczema Moisturizer Regimen and Cosmetic Moisturizer Regimen in people with Microbiota, run by Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiome Composition Changes in Lesion Skin - Baseline to Day 14 (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03673059, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2018.