Treatment of Moderate to Severe Facial Acne Vulgaris - Full Text View

Sponsor:	Warner Chilcott
Information provided by:	Warner Chilcott
ClinicalTrials.gov Identifier:	NCT00612573

Purpose

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.

Condition	Intervention	Phase
Acne Vulgaris	Drug: Doxycycline 0.6 mg/kg/day Drug: Doxycycline 1.2 mg/kg/day Drug: Doxycycline 2.4 mg/kg/day Drug: Placebo	Phase II

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

Resource links provided by NLM:

MedlinePlus related topics: Acne

Drug Information available for: Doxycycline Doxycycline hyclate Doxycycline calcium

U.S. FDA Resources

Further study details as provided by Warner Chilcott:

Primary Outcome Measures:

Percentage Patients With Successful Outcome Investigator's Global Assessment (IGA) Score at Week 12, Intent to Treat (ITT) Population [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
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.
Absolute Change in Inflammatory Lesion Count From Baseline to Week 12, ITT Population [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Absolute Change From Baseline to Week 12 in NonInflammatory Lesion Count, ITT Population [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
Noninflammatory Lesion Count includes open and closed comedones.
Absolute Change From Baseline to Week 12 in Total Lesion Count, ITT Population [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
Total Lesion Count is the sum of inflammatory and noninflammatory lesions.

Enrollment:	257
Study Start Date:	February 2008
Study Completion Date:	December 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Doxycyline 0.6 mg/kg/day Doxycycline dosed at 40 mg/day to subjects of appropriate weights	Drug: Doxycycline 0.6 mg/kg/day doxycycline 40 mg/day, oral, 12 weeks
Experimental: Doxycycline 1.2 mg/kg/day Doxycycline dosed at 80 mg/day to subjects of appropriate weights	Drug: Doxycycline 1.2 mg/kg/day doxycycline 80 mg/day, 12 weeks
Experimental: Doxycycline 2.4 mg/kg/day Doxycycline dosed at 160 mg/day to subjects of appropriate weights	Drug: Doxycycline 2.4 mg/kg/day doxycycline 160 mg/day, 12 weeks
Placebo Comparator: Placebo	Drug: Placebo Placebo, 12 weeks

Eligibility

Ages Eligible for Study:	12 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00612573

Show 23 Study Locations

Sponsors and Collaborators

Warner Chilcott

Investigators

Study Director:

Angelo Secci, MD

Warner Chilcott

More Information

No publications provided

Responsible Party:	Dr. Angelo Secci, Warner Chilcott
ClinicalTrials.gov Identifier:	NCT00612573 History of Changes
Other Study ID Numbers:	PR-07907, WC2055
Study First Received:	January 25, 2008
Results First Received:	February 14, 2011
Last Updated:	March 18, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Doxycycline
Doxycycline hyclate

Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on February 09, 2012