Clinical trial NCT00612573: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acne Vulgaris
Lead sponsor: Warner Chilcott
Sponsor class: INDUSTRY
First posted: 2008-02-11
Enrollment: 257
Sex: ALL
Minimum age (years): 12
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percentage Patients With Successful Outcome Investigator's Global Assessment (IGA) Score at Week 12, Intent to Treat (ITT) Population
timeFrame: Week 12
measure: Absolute Change in Inflammatory Lesion Count From Baseline to Week 12, ITT Population
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Absolute Change From Baseline to Week 12 in NonInflammatory Lesion Count, ITT Population
timeFrame: Baseline to Week 12
measure: Absolute Change From Baseline to Week 12 in Total Lesion Count, ITT Population
timeFrame: Baseline to Week 12
Other outcomes:
Locations:
city: Encino
country: United States
facility: Warner Chilcott Investigational Site
state: California
city: Fremont
country: United States
facility: Warner Chilcott Investigational Site
state: California
city: Los Angeles
country: United States
facility: Warner Chilcott Investigational Site
state: California
city: Sacramento
country: United States
facility: Warner Chilcott Investigational Site
state: California
city: Denver
country: United States
facility: Warner Chilcott Investigational Site
state: Colorado
city: Miami
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: Newnan
country: United States
facility: Warner Chilcott Investigational Site
state: Georgia
city: Snellville
country: United States
facility: Warner Chilcott Investigational Site
state: Georgia
city: Louisville
country: United States
facility: Warner Chilcott Investigational Site
state: Kentucky
city: Clinton Township
country: United States
facility: Warner Chilcott Investigational Site
state: Michigan
city: Albuquerque
country: United States
facility: Warner Chilcott Investigational Site
state: New Mexico
city: Rochester
country: United States
facility: Warner Chilcott Investigational Site
state: New York
city: Winston Salem
country: United States
facility: Warner Chilcott Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: Warner Chilcott Investigational Site
state: Ohio
city: Portland
country: United States
facility: Warner Chilcott Investigational Site
state: Oregon
city: Broomall
country: United States
facility: Warner Chilcott Investigational Site
state: Pennsylvania
city: Fort Washington
country: United States
facility: Warner Chilcott Investigational Site
state: Pennsylvania
city: Austin
country: United States
facility: Warner Chilcott Investigational Site
state: Texas
city: College Station
country: United States
facility: Warner Chilcott Investigational Site
state: Texas
city: Dallas
country: United States
facility: Warner Chilcott Investigational Site
state: Texas
city: Houston
country: United States
facility: Warner Chilcott Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Warner Chilcott Investigational Site
state: Texas
city: Spokane
country: United States
facility: Warner Chilcott Investigational Site
state: Washington
Study officials:
affiliation: Warner Chilcott
name: Angelo Secci, MD
role: STUDY_DIRECTOR
References: