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

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 Drug: Placebo	Phase II

MedlinePlus related topics:

Acne

Drug Information available for:

Doxycycline Doxycycline calcium Doxycycline hyclate

U.S. FDA Resources

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

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

Further study details as provided by Warner Chilcott:

Primary Outcome Measures:

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 Measures:

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 ]

Estimated Enrollment:	280
Study Start Date:	February 2008
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: doxycycline doxycycline 40 mg/day, oral
2: Experimental	Drug: doxycycline doxycycline 80 mg/day
3: Experimental	Drug: doxycycline doxycycline 160 mg/day
4: Placebo Comparator	Drug: Placebo Placebo

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

Responsible Party:	Warner Chilcott ( Dr. Angelo Secci )
Study ID Numbers:	PR-07907, WC2055
First Received:	January 25, 2008
Last Updated:	August 20, 2008
ClinicalTrials.gov Identifier:	NCT00612573
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Exanthema

Facial Dermatoses

Skin Diseases

Facies

Sebaceous Gland Diseases

Doxycycline

Acne Vulgaris

Additional relevant MeSH terms:

Antimalarials

Anti-Infective Agents

Anti-Bacterial Agents

Antiparasitic Agents

Antiprotozoal Agents

Acneiform Eruptions

Therapeutic Uses

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 23, 2008

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