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Treatment of Moderate to Severe Facial Acne Vulgaris

NCT00612573 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 257

Last updated 2013-04-22

Study results available
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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.

Conditions

  • Acne Vulgaris

Interventions

DRUG

Doxycycline 0.6 mg/kg/day

doxycycline 40 mg/day, oral, 12 weeks

DRUG

Doxycycline 1.2 mg/kg/day

doxycycline 80 mg/day, 12 weeks

DRUG

Doxycycline 2.4 mg/kg/day

doxycycline 160 mg/day, 12 weeks

DRUG

Placebo

Placebo, 12 weeks

Sponsors & Collaborators

  • Warner Chilcott

    lead INDUSTRY

Principal Investigators

  • Angelo Secci, MD · Warner Chilcott

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2008-11-30
Completion
2008-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00612573 on ClinicalTrials.gov