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: Doxycycline hyclate (Doryx) Drug: Doxycycline hyclate	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Randomized, Open-label Study to Evaluate the Efficacy and Safety of Doryx Tablets Compared 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:

Successful Outcome According to Investigator's Global Assessment (IGA) [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
The Investigator's Global Assessment (IGA) was performed at baseline and at 12 weeks. The IGA score is based on a 5-point acne severity scale from zero (clear) to 4 (severe). Successful outcome is at least a 2-point reduction in IGA score from baseline to 12 weeks.
Change From Baseline in Inflammatory Acne Lesion Count on the Face at 12 Weeks [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
Acne lesions fall into 2 groups: inflammatory and non-inflammatory. The number of inflammatory acne lesions on the face was measured at baseline and after 12 weeks. The difference (change) was calculated.

Secondary Outcome Measures:

Change From Baseline in Non-inflammatory Acne Lesion Count on the Face at 12 Weeks [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
Acne lesions fall into 2 groups: inflammatory and non-inflammatory. The number of non-inflammatory acne lesions on the face was measured at baseline and after 12 weeks. The difference (change) was calculated.

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
Experimental: Doxycycline hyclate (Doryx)	Drug: Doxycycline hyclate (Doryx) 150mg/day, oral, delayed release tablets Other Name: Doryx
Active Comparator: Doxycycline hyclate	Drug: Doxycycline hyclate 100 mg/day, oral, tablets, immediate release

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 to 12 weeks in inflammatory lesion count in patients with moderate to severe facial acne vulgaris. Additionally, the absolute change from baseline to 12 weeks 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, 33175
United States, Kentucky
Warner Chilcott Investigational Site
Louisville, Kentucky, United States, 40217
United States, New York
Warner Chilcott Investigational Site
Rochester, New York, United States, 14623

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:	NCT00635609 History of Changes
Other Study ID Numbers:	PR-08607
Study First Received:	March 7, 2008
Results First Received:	September 23, 2009
Last Updated:	December 22, 2010
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

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

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

ClinicalTrials.gov processed this record on February 09, 2012