Treatment of Moderate to Severe Facial Acne Vulgaris - Tabular View

Tracking Information

First Received Date ^ICMJE

January 25, 2008

Last Updated Date

January 27, 2009

Start Date ^ICMJE

February 2008

Primary Completion Date

November 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Primary efficacy variables will be both the IGA and the absolute change from baseline for inflammatory lesions count at Week 12. [ Time Frame: Evaluations will be made at days 0, 7, 14, 42, 56, 70, 84 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00612573 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Secondary efficacy variables will be the percent change in inflammatory lesion count and the absolute change from baseline for non-inflammatory and total lesions count at Week 12. [ Time Frame: Evaluations will be made at days 0, 7, 14, 42, 56, 70, 84 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Treatment of Moderate to Severe Facial Acne Vulgaris

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Acne Vulgaris

Intervention ^ICMJE

Drug: doxycycline
Drug: Placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

257

Completion Date

December 2008

Primary Completion Date

November 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Must be between 12 and 45 years of age.
Has a diagnosis of moderate to severe facial acne vulgaris with no more than two nodules on the face

Exclusion Criteria:

Is allergic to tetracycline-class antibiotics or to any ingredient in the study medication.
Has a history of pseudomembranous colitis or antibiotic-associated colitis.
Has a history of hepatitis or liver damage or renal impairment.

Gender

Both

Ages

12 Years to 45 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00612573

Responsible Party

Dr. Angelo Secci, Warner Chilcott

Study ID Numbers ^ICMJE

PR-07907, WC2055

Study Sponsor ^ICMJE

Warner Chilcott

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Angelo Secci, MD

Warner Chilcott

Information Provided By

Warner Chilcott

Verification Date

January 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP