An interventional study of OTC Eczema Moisturizer Regimen and Cosmetic Moisturizer Regimen in Microbiota, sponsored by Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.. Completed at 2 sites in United States. Open to participants aged 16 Years to 50 Years. Per ClinicalTrials.gov, last updated 2018-09-17.
Sponsored by Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc. (formerly part of Johnson & Johnson) · Not applicable, Interventional, and Basic science
Among 251 studies in Eczema with a site in United States — 34 open to participants now, 47 under way, 9 of them phase 3. Eczema · United States.
Among the 251 studies in Eczema with a site in United States, this one is the 114th largest by enrollment of the 216 interventional ones that give a count, is one of 11 that started in 2015, is one of 45 with no phase, and was the 106th registered.
503 studies on the registry are indexed under Eczema; 89 are open to participants now.
This study's enrollment of 91 is close to the median of 91 across 401 interventional studies indexed under Eczema.
Browse Eczema studies →34 of the 251 studies in Eczema with a site in United States are open now.
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 67 Eczema studies recruiting now, 31 (46%) set no upper age limit and 28 (42%) stop at 75 or younger; 35 take children under 18; 22 take healthy volunteers.
This study: 16 Years to 50 Years · all sexes · no healthy volunteers.
The full table on the hub →251 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 23 · Phase 2 83 · Phase 3 56 · Phase 4 17
First in 2003; this study’s year is marked. 11 started in 2015.
Median enrollment 102 across the 216 interventional studies, 243 across the 34 observational. Of the 182 that completed or were terminated, 111 (61%) have results posted.
164 of 251 have an industry lead sponsor. The 10 most frequent:
Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc. is the lead sponsor of 5 studies on the registry; none are open to participants now.
Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc. has 2 studies filed under Eczema — fewer than ten, so there is no comparison to draw.
15 of the studies in Eczema with a site in United States that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07355075Phase 3Turn TherapeuticsA Double-Blind, Randomized, Vehicle-Controlled Phase 2 Study to Assess the Efficacy and Safety of GX-03 in Adult Subjects With Moderate to Severe Atopic Dermatitis (Eczema) | 2027-01-20 |
| NCT06807268Phase 3PfizerA Study of the Medicine Called Abrocitinib in Children 6 to Less Than 12 Years of Age With Moderate-to-Severe Eczema | 2027-05-02 |
| NCT07265479Phase 3Organon and CoA Study to Investigate Safety and Efficacy of Tapinarof Cream, 1% in Participants Ages 3 Months to < 24 Months With Atopic Dermatitis | 2027-08 |
| NCT05995964PfizerA Study To Learn About Two Study Medicines (PF-07275315 And PF-07264660) In People Who Have Moderate To Severe Atopic Dermatitis | 2026-11-12 |
| NCT06928246Daniel KaplanThe Impact of Botox on Neuroimmune Interactions in Atopic Dermatitis | 2026-12-15 |
Among the 251 studies in Eczema with a site in United States, from their registry updates:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
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.
Time frame: 2 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1 week
Skin pH - Change - Baseline to Day 14
Change from baseline in pH of lesional skin at Day 14.
Time frame: 2 weeks
Skin pH - Change - Baseline to Day 7
Change from baseline in pH of lesional skin at Day 7.
Time frame: 1 week
Skin pH - Change - Baseline to Day 3
Change from baseline in pH of lesional skin at Day 3.
Time frame: 3 days
Skin pH - Change - Baseline to Day 1
Change from baseline in pH of lesional skin at Day 1.
Time frame: 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).
Time frame: 1 week
Skin Transepidermal Water Loss (TEWL) - Change - Baseline to Day 14
Change from baseline in TEWL of lesional skin at Day 14.
Time frame: 2 weeks
Skin Transepidermal Water Loss (TEWL) - Change - Baseline to Day 7
Change from baseline in TEWL of lesional skin at Day 7.
Time frame: 1 week
Skin Transepidermal Water Loss (TEWL) - Change - Baseline to Day 3
Change from baseline in TEWL of lesional skin at Day 3.
Time frame: 3 days
Skin Transepidermal Water Loss (TEWL) - Change - Baseline to Day 1
Change from baseline in TEWL of lesional skin at Day 1.
Time frame: 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).
Time frame: 1 week
Skin Hydration - Change - Baseline to Day 14
Change from baseline in Skin Hydration via conductance of lesional skin at Day 14.
Time frame: 2 weeks
Skin Hydration - Change - Baseline to Day 7
Change from baseline in Skin Hydration via conductance of lesional skin at Day 7.
Time frame: 1 week
Skin Hydration - Change - Baseline to Day 3
Change from baseline in Skin Hydration via conductance of lesional skin at Day 3.
Time frame: 3 days
Skin Hydration - Change - Baseline to Day 1
Change from baseline in Skin Hydration via conductance of lesional skin at Day 1.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 1 week
Plan to share: No
Ran from Mar 2015 to primary completion in Jun 2016, 14 months.
Of 33 industry-sponsored interventional studies with no phase under Eczema, half reached primary completion within 4 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 11. This study's 14 months is above that.
Counting every sponsor, half of 78 studies reached it within 11 months; a quarter within 4 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc. →