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NCT00865605 · ClinicalTrials.gov registry record · Phase 1

Pivotal Bioequivalence Study of Topically Delivered Halobetasol Propionate Ointment in Normal Skin in Healthy Adult Subjects

A Phase 1 study, sponsored by Actavis.

Completed
Registry status
Phase 1
Development phase
71
Enrollment target

NCT00865605: Completed Phase 1 study, sponsored by Actavis.

NCT00865605 is a Phase 1 study that has completed, run by Actavis. The registered enrollment target is 71 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (18% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00865605, a Phase 1 study, has completed, sponsored by Actavis.

COMPLETED
Registry status
Phase 1
Development phase
71 participants
Enrollment target

Study Summary

The purpose of this study is to compare the vasoconstriction response profile and bioequivalence between one innovator lot of Ultravate® 0.05% ointment and one test/generic lot of Halobetasol propionate 0.05% ointment (Alpharma USPD, Inc.).

Interventions

  • DRUG Ultravate® 0.05% ointment, single exposure
  • DRUG Halobetasol Propionate 0.05% Ointment, single exposure

Trial Details

FieldValue
Enrollment Target 71 participants
Start Date 2003-12
Est. Completion 2004-07
Phase Phase 1
Actavis

79 total trials

What the finished NCT00865605 record still lists

NCT00865605 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (18% higher).

The record links to 0 conditions, and to 2 interventions - of which Ultravate® 0.05% ointment, single exposure is the first listed.

NCT00865605 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00865605 about?

NCT00865605 is a clinical study titled "Pivotal Bioequivalence Study of Topically Delivered Halobetasol Propionate Ointment in Normal Skin in Healthy Adult Subjects". The purpose of this study is to compare the vasoconstriction response profile and bioequivalence between one innovator lot of Ultravate® 0.05% ointment and one test/generic lot of Halobetasol propionate 0.05% ointment (Alpharma USPD, Inc.).

What is the current status of trial NCT00865605?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 71 participants. The study started on 2003-12. Estimated completion is 2004-07.

What interventions are being tested in trial NCT00865605?

The interventions under investigation include: Ultravate® 0.05% ointment, single exposure (DRUG), Halobetasol Propionate 0.05% Ointment, single exposure (DRUG).

Who is sponsoring clinical trial NCT00865605?

This trial is sponsored by Actavis, which has 79 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00865605's enrollment target sits among peer trials

71 747th of 2000 higher than 1,252 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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Source: ClinicalTrials.gov NCT00865605, the US trial registry maintained by the National Library of Medicine. NCT00865605 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.