Treatment of Moderate to Severe Facial Acne Vulgaris - Tabular View

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Treatment of Moderate to Severe Facial Acne Vulgaris

This study is ongoing, but not recruiting participants.

Study NCT00612573. Last updated on August 20, 2008. Information provided by Warner Chilcott

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Treatment of Moderate to Severe Facial Acne Vulgaris

Official Title ^†

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 ^†

Interventional

Study Design ^†

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

Primary Outcome Measure ^†

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 ]

Secondary Outcome Measure ^†

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 ]

Condition ^†

Acne Vulgaris

Intervention ^†

Drug: doxycycline
Drug: Placebo

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

280

Start Date ^†

February 2008

Completion Date

Eligibility Criteria ^†

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 ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00612573

Organization ID

PR-07907

Secondary IDs ^††

WC2055

Study Sponsor ^†

Warner Chilcott

Collaborators ^††

Investigators ^†

Study Director:

Angelo Secci, MD

Warner Chilcott

Information Provided By

Warner Chilcott

Verification Date

August 2008

First Received Date ^†

January 25, 2008

Last Updated Date

August 20, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.