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NCT03847389 · ClinicalTrials.gov registry record · Phase 1
Clobetasol Topical Oil for Children With Moderate to Severe Atopic Dermatitis
A Phase 1 study, sponsored by Hill Dermaceuticals.
- Terminated
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT03847389: Clinical Trial Phase 1 study, sponsored by Hill Dermaceuticals.
NCT03847389 is a Phase 1 study that was terminated before completion, run by Hill Dermaceuticals. The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03847389, a Phase 1 study, was terminated before completion, sponsored by Hill Dermaceuticals.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
Open-Label Study designed to evaluate the HPA axis suppression potential of Clobetasol Topical Oil and pharmacokinetic safety / systemic exposure to clobetasol when Clobetasol Topical Oil is applied to pediatric subjects with moderate to severe atopic dermatitis (AD) under maximal use conditions. The study duration for each subject will be up to 54 days (up to 38 days for Screening assessments, followed by up to 16 days of treatment and follow-up). Additional time will be required for subjects requiring additional hypothalamic-pituitary-adrenal \[HPA\] axis function testing due to an abnormal result at End of Treatment.
Primary Outcome
30-minute Post-stimulation cortisol level ≤18 µg/100 mL at Day 0 means subject is not enrolled; 30-minute Post-stimulation cortisol level ≤18 µg/100 mL at end of treatment (Day 15) means subject had suppression.
Interventions
- DRUG Clobetasol propionate 0.05% Topical Oil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2019-09-09 |
| Est. Completion | 2020-07-28 |
| Phase | Phase 1 |
Why NCT03847389 stopped before completion
NCT03847389 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 1 intervention - of which Clobetasol propionate 0.05% Topical Oil is the first listed.
NCT03847389 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03847389 about?
NCT03847389 is a clinical study titled "Clobetasol Topical Oil for Children With Moderate to Severe Atopic Dermatitis". Open-Label Study designed to evaluate the HPA axis suppression potential of Clobetasol Topical Oil and pharmacokinetic safety / systemic exposure to clobetasol when Clobetasol Topical Oil is applied to pediatric subjects with moderate to severe atopic dermatitis (AD) under maximal use conditions. T...
What is the current status of trial NCT03847389?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2019-09-09. Estimated completion is 2020-07-28.
What interventions are being tested in trial NCT03847389?
The interventions under investigation include: Clobetasol propionate 0.05% Topical Oil (DRUG).
Who is sponsoring clinical trial NCT03847389?
This trial is sponsored by Hill Dermaceuticals, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03847389's enrollment target sits among peer trials
8 1959th of 2000 higher than 29 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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