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NCT04800185 · ClinicalTrials.gov registry record · Early Phase 1
Characterizing Skin Microbiome Change in Atopic Dermatitis
A Early Phase 1 study, sponsored by University of California, Irvine.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 20
- Enrollment target
NCT04800185: Completed Early Phase 1 study, sponsored by University of California, Irvine.
NCT04800185 is a Early Phase 1 study that has completed, run by University of California, Irvine. The registered enrollment target is 20 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04800185, a Early Phase 1 study, has completed, sponsored by University of California, Irvine.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
Atopic dermatitis (AD), also known as eczema, is an inflammatory disease of the skin affecting a large proportion of the pediatric and adult patient population. Chronic itching and eczematous lesions lead to a high burden of disease and associated patient morbidity with higher infection rates, emotional stress and associated psychological disease. The microbiome community contributes to human health through several mechanisms. Current research suggests that derangements in the normal microbiota may lead to inflammatory bowel disease, allergy, and metabolic syndromes. Specific to dermatology, new literature has demonstrated that changes in the microbiome may play a role in the development of atopic dermatitis. With this study, the investigators hope to characterize the baseline atopic dermatitis skin microbiome and monitor the evolution of the participants skin microbiome during and after treatment with anti-inflammatory topical medications, specifically the Food and Drug Administration (FDA)-approved phosphodiesterase inhibitor, crisaborole ointment 2% (Eucrisa).
Primary Outcome
To analyze the atopic dermatitis microbiome using advanced genomic techniques after treatment with topical PDE4 inhibitors. Using 16S library preparation, sequencing, merging of MiSeq paired-end sequence reads, and identification of operational taxonomic units, the investigators hope to identify the bacterial and fungal content of skin microbiome samples from 20 AD participants before and after treatment with crisaborole at a total of 6 visits over 16 weeks.
Interventions
- DRUG Crisaborole 2% Top Oint
- GENETIC Skin Microbiome Swabs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2021-03-23 |
| Est. Completion | 2022-04-30 |
| Phase | Early Phase 1 |
What the finished NCT04800185 record still lists
NCT04800185 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 2 interventions - of which Crisaborole 2% Top Oint is the first listed.
NCT04800185 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04800185 about?
NCT04800185 is a clinical study titled "Characterizing Skin Microbiome Change in Atopic Dermatitis". Atopic dermatitis (AD), also known as eczema, is an inflammatory disease of the skin affecting a large proportion of the pediatric and adult patient population. Chronic itching and eczematous lesions lead to a high burden of disease and associated patient morbidity with higher infection rates, emoti...
What is the current status of trial NCT04800185?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 20 participants. The study started on 2021-03-23. Estimated completion is 2022-04-30.
What interventions are being tested in trial NCT04800185?
The interventions under investigation include: Crisaborole 2% Top Oint (DRUG), Skin Microbiome Swabs (GENETIC).
Who is sponsoring clinical trial NCT04800185?
This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04800185's enrollment target sits among peer trials
20 1157th of 2000 higher than 710 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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