An interventional study of Colloidal Oatmeal and Topical Cream in Atopic Dermatitis, 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 6 Months to 18 Years. Per ClinicalTrials.gov, last updated 2012-08-03.
Sponsored by Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc. (formerly part of Johnson & Johnson) · Not applicable, Interventional, and Treatment
Among 639 studies in Dermatitis, Atopic with a site in United States — 78 open to participants now, 117 under way, 18 of them phase 3. Dermatitis, Atopic · United States.
Among the 639 studies in Dermatitis, Atopic with a site in United States, this one is the 277th largest by enrollment of the 544 interventional ones that give a count, is one of 11 that started in 2011, is one of 68 with no phase, and was the 98th registered.
1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.
This study's enrollment of 90 is close to the median of 82 across 1,246 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →78 of the 639 studies in Dermatitis, Atopic 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 193 Dermatitis, Atopic studies recruiting now, 83 (43%) set no upper age limit and 94 (49%) stop at 75 or younger; 93 take children under 18; 51 take healthy volunteers.
This study: 6 Months to 18 Years · all sexes · no healthy volunteers.
The full table on the hub →639 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 97 · Phase 2 221 · Phase 3 107 · Phase 4 70
First in 1996; this study’s year is marked. 11 started in 2011.
Median enrollment 96 across the 544 interventional studies, 155 across the 94 observational. Of the 491 that completed or were terminated, 265 (54%) have results posted.
429 of 639 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 1 study filed under Dermatitis, Atopic — fewer than ten, so there is no comparison to draw.
44 of the studies in Dermatitis, Atopic with a site in United States that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06389136Phase 3AbbVieA Study of Upadacitinib in Adult Participants With Moderate-to-Severe Atopic Dermatitis and Inadequate Response to Dupilumab | 2026-11 |
| 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 |
| 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 |
| NCT06241118Phase 3SanofiA Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab on Background Topical Corticosteroids Therapy in Participants Aged 12 Years and Older With Moderate-to-severe AD Who Have Had an Inadequate Response to Prior Biologic Therapy or an Oral JAK Inhibitor | 2027-09-30 |
| NCT06395948Apogee Therapeutics, Inc.A Study Evaluating APG777 in Atopic Dermatitis | 2026-11 |
Among the 639 studies in Dermatitis, Atopic with a site in United States, from their registry updates:
This three week study will be conducted to determine the safety and efficacy of an over-the-counter (OTC) cream in children with mild to moderate atopic dermatitis.
The objective of this trial is to evaluate the efficacy and safety of an OTC colloidal oatmeal skin protectant cream in children with mild to moderate AD in comparison to that of EpiCeram®
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.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
Experimental Topical cream applied twice daily (or as needed)
Drug: Colloidal Oatmeal
Marketed Topical cream applied twice daily (or as needed)
Device: Topical Cream
Topical cream applied twice daily (or as needed)
Also known as: Not yet marketed
Topical cream applied twice daily (or as needed)
Also known as: EpiCeram
Eczema Area and Severity Index (EASI)
A regional body surface area tabulation based on severity ranging from 0 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72
Time frame: 3 weeks
Interim Eczema Area and Severity Index (EASI)
Number of subjects improved at Week 2 compared to Baseline in EASI. Improved is defined as post baseline EASI score smaller than baseline score.
Time frame: Week 2
Assessment of Itch
Subject's or caregiver's assessment of itch, on a 10-cm Visual Analogue Scale (VAS), where 0-no itch, 10-worst itch imaginable
Time frame: through Week 3
Investigator's Global Atopic Dermatitis Assessment (IGADA)
An assessment of Atopic Dermatitis based on a 4 point scale where 0 (none) and 3 (severe) are used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating will be 0-clear, 1-almost clear, 2-mild, 3-moderate, 4-severe, or 5-very severe.
Time frame: through Week 3
| Milestone | 19306-127 | 19306-137 |
|---|---|---|
| Started | 45 | 45 |
| Completed | 41 | 42 |
| Not completed | 4 | 3 |
| Withdrew: Withdrawal by subject | 3 | 2 |
| Withdrew: Protocol violation | 1 | 1 |
A regional body surface area tabulation based on severity ranging from 0 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72
| units on a scale | 19306-127 | 19306-137 |
|---|---|---|
| Day 0, Baseline | 3.014 ± 1.9473 | 3.359 ± 3.6925 |
| Day 7, Week 1 | 1.286 ± 1.0137 | 1.621 ± 1.9275 |
| Day 14, Week 2 | 1.310 ± 2.0153 | 1.298 ± 1.5811 |
| Day 21, Week 3 | 1.154 ± 1.1570 | 1.064 ± 1.1320 |
Number of subjects improved at Week 2 compared to Baseline in EASI. Improved is defined as post baseline EASI score smaller than baseline score.
| participants | 19306-127 | 19306-137 |
|---|---|---|
| Improved | 38 ± 1.8789 | 38 ± 2.8447 |
| Not Improved | 3 | 4 |
Subject's or caregiver's assessment of itch, on a 10-cm Visual Analogue Scale (VAS), where 0-no itch, 10-worst itch imaginable
| units on a scale | 19306-127 | 19306-137 |
|---|---|---|
| Day 0, Baseline | 1.557 ± 2.2526 | 1.208 ± 2.4939 |
| Day 7, Week 1 | 1.840 ± 2.2876 | 1.537 ± 2.2051 |
| Day 14, Week 2 | 2.199 ± 2.4595 | 1.480 ± 2.1464 |
| Day 21, Week 3 | 1.972 ± 2.7890 | 1.685 ± 2.5902 |
An assessment of Atopic Dermatitis based on a 4 point scale where 0 (none) and 3 (severe) are used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating will be 0-clear, 1-almost clear, 2-mild, 3-moderate, 4-severe, or 5-very severe.
| units on a scale | 19306-127 | 19306-137 |
|---|---|---|
| Day 0, Baseline | 2.159 ± 0.6078 | 2.182 ± 0.6567 |
| Day 7, Week 1 | 1.690 ± 0.6803 | 1.667 ± 0.7861 |
| Day 14, Week 2 | 1.585 ± 0.7062 | 1.548 ± 0.8025 |
| Day 21, Week 3 | 1.585 ± 0.8055 | 1.381 ± 0.7949 |
Collected over Three Weeks plus 30 days for Serious Adverse Events. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 19306-127 | — | 0/45 (0%) | 6/45 (13.3%) |
| 19306-137 | — | 0/45 (0%) | 2/45 (4.4%) |
| Event | 19306-127 | 19306-137 |
|---|---|---|
| PRURITUSSkin and subcutaneous tissue disorders | 2/45 | 1/45 |
| PYREXIAGeneral disorders | 2/45 | 0/45 |
| RASH PRURITICSkin and subcutaneous tissue disorders | 1/45 | 0/45 |
| SEASONAL ALLERGYImmune system disorders | 1/45 | 0/45 |
| EAR INFECTIONInfections and infestations | 0/45 | 1/45 |
| Age Continuous(years) | 19306-127 | 19306-137 | Total |
|---|---|---|---|
| Mean | 6.9 ± 3.26 | 9.3 ± 4.26 | 8.1 ± 3.96 |
| Sex: Female, Male(Participants) | 19306-127 | 19306-137 | Total |
|---|---|---|---|
| Female | 23 | 26 | 49 |
| Male | 22 | 19 | 41 |
| Region of Enrollment(participants) | 19306-127 | 19306-137 | Total |
|---|---|---|---|
| United States | 45 | 45 | 90 |
The record gives a start of Mar 2011, a primary completion of May 2011 and a completion of Jun 2011. It does not say whether these dates are actual or estimated.
Results were first posted in Aug 2012, 1 year 3 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Oatmeal
Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc. →