Double-Blind, Placebo-Controlled Study to Evaluate 3 Doses of a Novel Tetracycline in the Treatment of Facial Acne Vulgaris

Summary

To evaluate the safety and effectiveness of 3 strengths of P005672-HCl compared to placebo for the treatment of moderate to severe facial acne vulgaris.

Timeline

Start

2012-06-30

Primary completion

2012-11-16

Completion

2013-01-31

Outcome

Mixed primary results

registry analysis (superiority test); Placebo vs P005672-HCl Approximately 1.5 mg/kg/Day; p = 0.0266; Difference in Least Squares Means 4.46 (95% CI 0.52 to 8.40); ANCOVA NCT01628549 ↗

registry analysis (superiority test); Placebo vs P005672-HCl Approximately 3.0 mg/kg/Day; p = 0.4834; Difference vs placebo in success rate 4.1 (95% CI -7.44 to 15.87); Cochran-Mantel-Haenszel NCT01628549 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	P005672-HCl	Small molecule	50 mg	Oral
Subject	P005672-HCl	Small molecule	100 mg	Oral

Indications