Safety and Efficacy Study to Compare Two Rosacea Treatment Regimens

December 11, 2008 updated by: CollaGenex Pharmaceuticals

Determine the Effects of COL-101 Administered Once Daily With Metronidazole Topical Gel, 1% Versus Doxycycline Hyclate 100 mg Administered Once Daily With Metronidazole Topical Gel, 1% in Patients With Moderate to Severe Rosacea

To compare the safety and efficacy of two treatment regimens: 1) COL-101 and metronidazole gel 1%; 2) Doxycycline hyclate 100 mg and metronidazole gel 1%

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Compare the safety and efficacy of two treatment regimens: 1) COL-101 and metronidazole gel 1%; 2) Doxycycline hyclate 100 mg and metronidazole gel 1%

Study Type

Interventional

Enrollment (Actual)

91

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
    • Nebraska
      • Omaha, Nebraska, United States, 68144
        • Joel Schlessinger
    • Nevada
      • Las Vegas, Nevada, United States, 89052
        • James Del Rosso
    • Texas
      • Arlington, Texas, United States, 76011
        • Angela Moore
      • Dallas, Texas, United States, 75230
        • William Abramovits
    • Utah
      • West Jordan, Utah, United States, 84088
        • Douglas Forsha
    • Washington
      • Seattle, Washington, United States, 98101
        • Bernard Goffe
      • Spokane, Washington, United States, 99204
        • William Werschler

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 8-40 total lesions
  • erythema
  • telangiectasia

Exclusion Criteria:

  • non-pregnant, non-lactating
  • achlorhydric
  • gastric by-pass surgery
  • allergy to study medications
  • drug/alcohol abuse
  • use of proton pump inhibitors

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cohort 1: doxycycline
Vibramycin plus metronidazole
Drug: doxycycline
COL-101, QD plus metronidazole
Other Names:
  • Vibramycin, 100 mg, QD plus metornidazole
Drug: doxycycline
40 mg with metronidazole QD
Other Names:
  • Oracea® 40 mg plus metronidazole
Active Comparator: Cohort 2
Oracea® delayed release plus metronidazole
Drug: doxycycline
COL-101, QD plus metronidazole
Other Names:
  • Vibramycin, 100 mg, QD plus metornidazole
Drug: doxycycline
40 mg with metronidazole QD
Other Names:
  • Oracea® 40 mg plus metronidazole

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in total lesion count from Baseline at the study endpoint
Time Frame: 16 weeks
16 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Investigator's Global Assessment from Baseline at the study endpoint
Time Frame: 16 weeks
16 weeks
Change in Clinician's Erythema Assessment score from Baseline at the study endpoint
Time Frame: 16 weeks
16 weeks
Change in total lesion count (papules + pustules + nodules) from Baseline at each visit
Time Frame: 4 weeks, 8 weeks, 12 weeks
4 weeks, 8 weeks, 12 weeks

Collaborators and Investigators

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

Sponsor

CollaGenex Pharmaceuticals

Investigators

  • Study Chair: Christopher V Powala, JD, CollaGenex Pharmaceuticals

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, 2007

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

June 29, 2007

First Submitted That Met QC Criteria

June 29, 2007

First Posted (Estimate)

July 3, 2007

Study Record Updates

Last Update Posted (Estimate)

December 16, 2008

Last Update Submitted That Met QC Criteria

December 11, 2008

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COL101-ROSE-401

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.

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