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NCT03992261 · ClinicalTrials.gov registry record · Phase 4
Adrenal Suppression and Absorption Study of Halobetasol Propionate Foam in Subjects 12-17 With Plaque Psoriasis
A Phase 4 study of Plaque Psoriasis, sponsored by Mayne Pharma International Pty.
- Completed
- Registry status
- Phase 4
- Development phase
- 24
- Enrollment target
- 11
- Study locations
NCT03992261: Completed Phase 4 study of Plaque Psoriasis, sponsored by Mayne Pharma International Pty.
NCT03992261 is a Phase 4 study of Plaque Psoriasis that has completed, run by Mayne Pharma International Pty. The registered enrollment target is 24 participants, below the 415-participant average among 45 other Plaque Psoriasis trials with a reported enrollment target (94% lower). The trial reports 11 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03992261, a Phase 4 study of Plaque Psoriasis, has completed, sponsored by Mayne Pharma International Pty.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 24 participants
- Enrollment target
- 11
- Study locations
Study Summary
The purpose of this study is to evaluate Halobetasol Propionate (HBP) foam, 0.05% in subjects aged 12 through less than 18 years with plaque psoriasis in order to check the safety, the potential to suppress the adrenal glands and the degree to which the drug is absorbed into the bloodstream.
Primary Outcome
A subject is considered to have adrenal suppression evidence if post cosyntropin stimulation lab draw result is less than or equal to 18.0 mcg/100 mL. HPA axis responses to cosyntropin were dichotomized to normal and abnormal. Cosyntropin stimulation testing was performed at Screening and Day 15 and approximately 4 weeks post-treatment if a subject's laboratory results at Day 15 showed an abnormal hypothalamic pituitary adrenal (HPA) axis response (HPA axis suppression). An abnormal HPA axis re
Conditions Studied
Interventions
- DRUG Halobetasol Topical Foam
Study Locations (11)
Other
- Investigative Site 9 - Batumi
- Investigative Site 10 - Tbilisi
- Investigative Site 11 - Tbilisi
- Investigative Site 3 - Krakow
- Investigative Site 5 - Tarnów
- Investigative Site 4 - Warsaw
- Investigative Site 8 - Rivne
- Investigative Site 6 - Uzhhorod
- Investigative Site 7 - Zaporizhzhya
Florida
- Investigative Site 2 - Hialeah
Missouri
- Investigative Site 1 - Saint Joseph
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2019-06-14 |
| Est. Completion | 2019-12-30 |
| Phase | Phase 4 |
What the finished NCT03992261 record still lists
NCT03992261 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 415-participant average among 45 other Plaque Psoriasis trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Plaque Psoriasis appearing as the primary indexed condition, and to 1 intervention - of which Halobetasol Topical Foam is the first listed.
NCT03992261 lists 11 locations in 3 states (Other, Florida, Missouri).
Frequently Asked Questions
What is clinical trial NCT03992261 about?
NCT03992261 is a clinical study titled "Adrenal Suppression and Absorption Study of Halobetasol Propionate Foam in Subjects 12-17 With Plaque Psoriasis". The purpose of this study is to evaluate Halobetasol Propionate (HBP) foam, 0.05% in subjects aged 12 through less than 18 years with plaque psoriasis in order to check the safety, the potential to suppress the adrenal glands and the degree to which the drug is absorbed into the bloodstream.
What is the current status of trial NCT03992261?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 24 participants. The study started on 2019-06-14. Estimated completion is 2019-12-30.
What conditions does trial NCT03992261 study?
This clinical trial studies the following conditions: Plaque Psoriasis.
What interventions are being tested in trial NCT03992261?
The interventions under investigation include: Halobetasol Topical Foam (DRUG).
Who is sponsoring clinical trial NCT03992261?
This trial is sponsored by Mayne Pharma International Pty, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03992261 being conducted?
This trial has 11 study locations across Florida, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Plaque Psoriasis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03992261's enrollment target sits among peer trials
24 43rd of 45 higher than 2 of 45 other Plaque Psoriasis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Plaque Psoriasis 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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