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

Tracking Information

First Received Date ^ICMJE

March 7, 2008

Last Updated Date

January 27, 2009

Start Date ^ICMJE

March 2008

Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00635609 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Treatment of Acne Vulgaris With Doryx Tablets Compared to Doxycyline Hyclate

Official Title ^ICMJE

Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Doryx Tablets to Doxycycline Hyclate in the Treatment of Acne Vulgaris.

Brief Summary

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.

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.

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Acne Vulgaris

Intervention ^ICMJE

Drug: Doxycylcine hyclate
Drug: Doxycycline hyclate

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2008

Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

12 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00635609

Responsible Party

Dr. Angelo Secci, Warner Chilcott

Study ID Numbers ^ICMJE

PR-08607

Study Sponsor ^ICMJE

Warner Chilcott

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Angelo Secci, MD

Warner Chilcott

Information Provided By

Warner Chilcott

Verification Date

January 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP