Treatment of Acne Vulgaris With Doryx Tablets Compared to Doxycyline Hyclate

April 18, 2012 updated by: Warner Chilcott

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

93

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Vista, California, United States, 92083
        • Warner Chilcott Investigational Site
    • Florida
      • Miami, Florida, United States, 33175
        • Warner Chilcott Investigational Site
    • Kentucky
      • Louisville, Kentucky, United States, 40217
        • Warner Chilcott Investigational Site
    • New York
      • Rochester, New York, United States, 14623
        • Warner Chilcott Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Doxycycline hyclate (Doryx)
Drug: Doxycycline hyclate (Doryx)
150mg/day, oral, delayed release tablets
Other Names:
  • Doryx
Active Comparator: Doxycycline hyclate
Drug: Doxycycline hyclate
100 mg/day, oral, tablets, immediate release

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful Outcome According to Investigator's Global Assessment (IGA)
Time Frame: baseline and 12 weeks
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.
baseline and 12 weeks
Change From Baseline in Inflammatory Acne Lesion Count on the Face at 12 Weeks
Time Frame: baseline and 12 weeks
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.
baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Non-inflammatory Acne Lesion Count on the Face at 12 Weeks
Time Frame: baseline and 12 weeks
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.
baseline and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Warner Chilcott

Investigators

  • Study Director: Angelo Secci, MD, Warner Chilcott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

March 7, 2008

First Submitted That Met QC Criteria

March 13, 2008

First Posted (Estimate)

March 14, 2008

Study Record Updates

Last Update Posted (Estimate)

April 20, 2012

Last Update Submitted That Met QC Criteria

April 18, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR-08607

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acne Vulgaris

Clinical Trials on Doxycycline hyclate (Doryx)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Croatia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe