Treatment of Moderate to Severe Facial Acne Vulgaris

Acne Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00612573
• Other study ID #: PR-07907
• Secondary ID: WC2055
• Status: Completed
• Phase: Phase 2
• First received: January 25, 2008
• Last updated: April 15, 2013
• Start date: February 2008
• Est. completion date: December 2008

Study information

• Verified date: April 2013
• Source: Warner Chilcott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 257
• Est. completion date: December 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• Doxycycline 0.6 mg/kg/day
doxycycline 40 mg/day, oral, 12 weeks
• Doxycycline 1.2 mg/kg/day
doxycycline 80 mg/day, 12 weeks
• Doxycycline 2.4 mg/kg/day
doxycycline 160 mg/day, 12 weeks
• Placebo
Placebo, 12 weeks

Locations

Country	Name	City	State
United States	Warner Chilcott Investigational Site	Albuquerque	New Mexico
United States	Warner Chilcott Investigational Site	Austin	Texas
United States	Warner Chilcott Investigational Site	Broomall	Pennsylvania
United States	Warner Chilcott Investigational Site	Cincinnati	Ohio
United States	Warner Chilcott Investigational Site	Clinton Township	Michigan
United States	Warner Chilcott Investigational Site	College Station	Texas
United States	Warner Chilcott Investigational Site	Dallas	Texas
United States	Warner Chilcott Investigational Site	Denver	Colorado
United States	Warner Chilcott Investigational Site	Encino	California
United States	Warner Chilcott Investigational Site	Fort Washington	Pennsylvania
United States	Warner Chilcott Investigational Site	Fremont	California
United States	Warner Chilcott Investigational Site	Houston	Texas
United States	Warner Chilcott Investigational Site	Los Angeles	California
United States	Warner Chilcott Investigational Site	Louisville	Kentucky
United States	Warner Chilcott Investigational Site	Miami	Florida
United States	Warner Chilcott Investigational Site	Newnan	Georgia
United States	Warner Chilcott Investigational Site	Portland	Oregon
United States	Warner Chilcott Investigational Site	Rochester	New York
United States	Warner Chilcott Investigational Site	Sacramento	California
United States	Warner Chilcott Investigational Site	San Antonio	Texas
United States	Warner Chilcott Investigational Site	Snellville	Georgia
United States	Warner Chilcott Investigational Site	Spokane	Washington
United States	Warner Chilcott Investigational Site	Winston Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Warner Chilcott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage Patients With Successful Outcome Investigator's Global Assessment (IGA) Score at Week 12, Intent to Treat (ITT) Population	IGA: 0/clear (clear skin no lesions, inflammatory or non-inflammatory), 1/almost clear (rare non-inflammatory lesion w/no more than 1 small inflammatory lesion), 2/mild (some non-inflammatory lesions with no more than a few inflammatory lesions, papules/pustules only, no nodular lesions), 3/moderate (up to many non-inflammatory lesions, some inflammatory lesions, no more than 1 small nodular lesion), 4/severe (many non-inflammatory & inflammatory lesions, no more than a few nodular lesions. Lower score improvement in score. Success=IGA decrease of at least 2 grades from baseline score.	Week 12	No
Primary	Absolute Change in Inflammatory Lesion Count From Baseline to Week 12, ITT Population	Change derived as Baseline evaluation minus the Week 12 evaluation. Thus a positive change reflects a reduction in lesion count. Inflammatory Lesion Count includes nodules, papules and pustules.	Baseline to Week 12	No
Secondary	Absolute Change From Baseline to Week 12 in NonInflammatory Lesion Count, ITT Population	Noninflammatory Lesion Count includes open and closed comedones.	Baseline to Week 12	No
Secondary	Absolute Change From Baseline to Week 12 in Total Lesion Count, ITT Population	Total Lesion Count is the sum of inflammatory and noninflammatory lesions.	Baseline to Week 12	No