Treatment of Acne Vulgaris With Doryx Tablets Compared to Doxycyline Hyclate - Full Text View

Sponsor:	Warner Chilcott
Information provided by:	Warner Chilcott
ClinicalTrials.gov Identifier:	NCT00635609

Purpose

Randomized, multi-center, open label, active-comparator study to compare the efficacy and tolerability of Doryx Delayed Release Tablets to doxycycline hyclate in patients with moderate to severe acne vulgaris.

Condition	Intervention	Phase
Acne Vulgaris	Drug: Doxycylcine hyclate Drug: Doxycycline hyclate	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Doryx Tablets to Doxycycline Hyclate in the Treatment of 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:

Primary efficacy variables will be both the dichotomized IGA score; where "success" is defined as at least a two grade decrease from baseline on the rating scale at Week 12; and the absolute change from baseline for inflammatory lesions count at Week 12. [ Time Frame: Evaluations will be made at weeks 0, 1, 4, 8 and 12. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The secondary efficacy variable will be the percent change in inflammatory lesion count and the absolute change from baseline for non-inflammatory lesion count at Week 12. [ Time Frame: Evaluations will be made at weeks 0, 1, 4, 8 and 12 ] [ Designated as safety issue: No ]
Tolerability [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]

Enrollment:	93
Study Start Date:	March 2008
Study Completion Date:	September 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Doxycylcine hyclate 150mg/day, oral, delayed release tablets
2: Active Comparator	Drug: Doxycycline hyclate 100 mg/day, oral, tablets

Detailed Description:

Efficacy of Doryx Delayed Release Tablets to doxycycline hyclate will be assessed using an 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 lesions count of Doryx Delayed Release Tablets compared to doxycycline hyclate will be evaluated.

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Must be 12 years of age or older.
Has a diagnosis of 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: NCT00635609

Locations

United States, California
Warner Chilcott Investigational Site
Vista, California, United States, 92083
United States, Florida
Warner Chilcott Investigational Site
Miami, Florida, United States
United States, Kentucky
Warner Chilcott Investigational Site
Louisville, Kentucky, United States
United States, New York
Warner Chilcott Investigational Site
Rochester, New York, United States

Sponsors and Collaborators

Warner Chilcott

Investigators

Study Director:

Angelo Secci, MD

Warner Chilcott

More Information

No publications provided

Responsible Party:	Warner Chilcott ( Dr. Angelo Secci )
Study ID Numbers:	PR-08607
Study First Received:	March 7, 2008
Last Updated:	January 27, 2009
ClinicalTrials.gov Identifier:	NCT00635609 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Anti-Infective Agents
Antiprotozoal Agents
Facial Dermatoses
Skin Diseases
Sebaceous Gland Diseases
Acne Vulgaris
Pharmacologic Actions

Anti-Bacterial Agents
Antimalarials
Antiparasitic Agents
Acneiform Eruptions
Therapeutic Uses
Doxycycline

ClinicalTrials.gov processed this record on November 27, 2009