CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 257 enrolled
Drug / intervention
Doxycycline 0.6 mg/kg/day +3 moredrug
Likely dose
Doxycycline 0.6 mg/kg/dayfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00612573
NCT00612573Phase 2Completed
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Phase 2 Study Randomized, Double-blind Study to Evaluate the Safety and Efficacy of 3 Doses of Doxycycline as Compared to Placebo in the Treatment of Moderate to Severe Facial Acne Vulgaris

Warner Chilcott·interventional·Posted Feb 11, 2008·Updated Apr 22, 2013

In Brief

A Phase 2 clinical trial evaluating Doxycycline 0.6 mg/kg/day, Doxycycline 1.2 mg/kg/day, and 2 other interventions for Acne Vulgaris. Completed, enrolled 257 participants across 23 sites.

Detailed Summary

Randomized, multi-center, double-blind, placebo-controlled 12-week study to assess the safety and efficacy of 3 doses of an oral formulation of Doxycycline oral tablets using the Investigator's Global Assessment (IGA) score and the absolute change from baseline in inflammatory lesion count in patients with moderate to severe facial acne vulgaris. Additionally, the absolute change from baseline in non-inflammatory and total lesions of the active study medication to placebo will be evaluated.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcne Vulgaris
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 11, 2008
Enrollment StartFeb 1, 2008
Primary CompletionNov 1, 2008
Study CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 18.4 years ago

Interventions

Doxycycline 0.6 mg/kg/daydrug

doxycycline 40 mg/day, oral, 12 weeks

Doxycycline 1.2 mg/kg/daydrug

doxycycline 80 mg/day, 12 weeks

Doxycycline 2.4 mg/kg/daydrug

doxycycline 160 mg/day, 12 weeks

Placebodrug

Placebo, 12 weeks