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NCT03212963 · ClinicalTrials.gov registry record · Phase 4
Evaluation of Adrenal Suppression Potential and Pharmacokinetics of Halobetasol Lotion 0.05%
A Phase 4 study, sponsored by Sun Pharmaceutical Industries Limited.
- Terminated
- Registry status
- Phase 4
- Development phase
- 16
- Enrollment target
NCT03212963: Clinical Trial Phase 4 study, sponsored by Sun Pharmaceutical Industries Limited.
NCT03212963 is a Phase 4 study that was terminated before completion, run by Sun Pharmaceutical Industries Limited. The registered enrollment target is 16 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03212963, a Phase 4 study, was terminated before completion, sponsored by Sun Pharmaceutical Industries Limited.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 16 participants
- Enrollment target
Study Summary
The objective of this open-label multicentric study is to determine the adrenal suppression potential and the pharmacokinetic (PK) properties of halobetasol lotion (HBP) applied twice daily for up to two weeks in subjects aged 12 to 16 years 11 months with stable plaque psoriasis. Subject enrollment will continue until at least 20 subjects with both screening and end of study (EOS) serum cortisol data (pre- and pos-tcosyntropin stimulation) have completed the study without any significant protocol violations (evaluable subjects). This may require the enrollment of approximately 25 subjects.
Primary Outcome
The IGA score (5-point scale of 0 to 4: 0\[clear\]; 1\[almost clear\]; 2\[mild\]; 3\[moderate\]; 4\[severe\]) is an evaluation of the overall severity of a subject's psoriasis in the Treatment Area and takes into consideration the 3 individual characteristics of psoriasis (scaling, erythema, and plaque elevation).
Interventions
- DRUG Halobetasol Topical Lotion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2017-03-21 |
| Est. Completion | 2019-08-12 |
| Phase | Phase 4 |
Why NCT03212963 stopped before completion
NCT03212963 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Halobetasol Topical Lotion is the first listed.
NCT03212963 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03212963 about?
NCT03212963 is a clinical study titled "Evaluation of Adrenal Suppression Potential and Pharmacokinetics of Halobetasol Lotion 0.05%". The objective of this open-label multicentric study is to determine the adrenal suppression potential and the pharmacokinetic (PK) properties of halobetasol lotion (HBP) applied twice daily for up to two weeks in subjects aged 12 to 16 years 11 months with stable plaque psoriasis. Subject enrollment...
What is the current status of trial NCT03212963?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 16 participants. The study started on 2017-03-21. Estimated completion is 2019-08-12.
What interventions are being tested in trial NCT03212963?
The interventions under investigation include: Halobetasol Topical Lotion (DRUG).
Who is sponsoring clinical trial NCT03212963?
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 NCT03212963's enrollment target sits among peer trials
16 1869th of 2000 higher than 121 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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