NCT00865605: Topical halobetasol bioequivalence in healthy adults

This was a topical halobetasol-propionate bioequivalence study in normal adult skin. The inspected record specifies 0.05% ointment, comparing a generic/test lot with Ultravate ointment; it should not be silently called a cream trial when reproducing this version of the record. 1 2

The phase 1, single-blind, single-exposure study reports 71 actual participants. Its principal measurement was skin vasoconstrictor response—the blanching response used to characterize topical corticosteroid activity. The historical record is marked completed and was updated in August 2010. 1 2

I did not verify the numerical bioequivalence confidence interval or acceptance result. The protocol therefore establishes the formulation comparison, but not a documented pass/fail conclusion here. It was not a psoriasis treatment trial and does not establish comparative disease clearance, long-term safety, or a recommended duration of steroid use. 1 2

Sources

1. ClinicalTrials.gov — ClinicalTrials.gov — NCT00865605. Original study registration: sponsor, design, population, endpoints and dated history.Original study registration · Original record checked against the registry API. Checked 2026-10-10. Registration and current registry fields do not by themselves establish efficacy. Historical details in the article retain their stated date. Supplied note: ClinicalTrials.gov — NCT00865605. Original study registration: sponsor, design, population, endpoints and dated history.