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NCT03245385 · ClinicalTrials.gov registry record · Phase 2
Multiple-Dose Pharmacokinetics and Potential for Adrenal Suppression Following Treatment With Halobetasol Spray in Patients With Atopic Dermatitis
A Phase 2 study, sponsored by Sun Pharmaceutical Industries Limited.
- Terminated
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT03245385: Clinical Trial Phase 2 study, sponsored by Sun Pharmaceutical Industries Limited.
NCT03245385 is a Phase 2 study that was terminated before completion, run by Sun Pharmaceutical Industries Limited. The registered enrollment target is 20 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03245385, a Phase 2 study, was terminated before completion, sponsored by Sun Pharmaceutical Industries Limited.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study Summary
This is an open-label, safety study designed to assess the multiple-dose pharmacokinetics and potential for adrenal suppression following topical treatment with halobetasol propionate 0.05% spray applied twice-daily in adult patients with moderate to severe atopic dermatitis. At least 40 eligible patients with atopic dermatitis that satisfy all eligibility criteria will be enrolled into the study
Primary Outcome
Patients will be considered to have shown improvement in disease severity if the IGA score decreases by at least one unit from the baseline score, and will be considered a treatment success if the IGA score is either 0 (clear) or 1 (almost clear).
Interventions
- DRUG Treatment with Halobetasol propionate 0.05% topical spray
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2017-07-24 |
| Est. Completion | 2018-02-05 |
| Phase | Phase 2 |
Why NCT03245385 stopped before completion
NCT03245385 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 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 1 intervention - of which Treatment with Halobetasol propionate 0.05% topical spray is the first listed.
NCT03245385 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03245385 about?
NCT03245385 is a clinical study titled "Multiple-Dose Pharmacokinetics and Potential for Adrenal Suppression Following Treatment With Halobetasol Spray in Patients With Atopic Dermatitis". This is an open-label, safety study designed to assess the multiple-dose pharmacokinetics and potential for adrenal suppression following topical treatment with halobetasol propionate 0.05% spray applied twice-daily in adult patients with moderate to severe atopic dermatitis. At least 40 eligible pa...
What is the current status of trial NCT03245385?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2017-07-24. Estimated completion is 2018-02-05.
What interventions are being tested in trial NCT03245385?
The interventions under investigation include: Treatment with Halobetasol propionate 0.05% topical spray (DRUG).
Who is sponsoring clinical trial NCT03245385?
This trial is sponsored by Sun Pharmaceutical Industries Limited, which has 38 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03245385's enrollment target sits among peer trials
20 1805th of 2000 higher than 107 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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