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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 is a Phase 4 study that was terminated before completion, run by Sun Pharmaceutical Industries Limited. The registered enrollment target is 16 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03212963
The ClinicalTrials.gov registry entry for NCT03212963 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sun Pharmaceutical Industries Limited, which has 38 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Halobetasol Topical Lotion is the first listed.
NCT03212963 reports 0 study locations.
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.
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