A Clinical Trial to Determine the Effects of 40 Mg Doxycycline Versus a Placebo Control for the Treatment of Rosacea

August 18, 2005 updated by: CollaGenex Pharmaceuticals
The objective of this study is to evaluate the safety and efficacy of 40 mg doxycycline controlled-release capsules administered once daily for the treatment of rosacea compared with a placebo.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

528

Phase

  • Phase 3

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

No

Genders Eligible for Study

All

Description

Main Inclusion Criteria:

  • Healthy patients with rosacea
  • Males and females ≥18 years of age
  • 10 to 40 papules and pustules and ≤2 nodules
  • Score of 2 to 4 on the IGA
  • Presence of telangiectasia
  • Moderate to severe erythema

Main Exclusion Criteria:

  • Use of topical acne treatments or topical or systemic antibiotics
  • Use of systemic retinoids within 90 days of baseline
  • Use of an investigational drug within 90 days of baseline
  • Pregnant or nursing women
  • Women of childbearing potential not using an adequate form of contraception
  • Change in method of contraception within 4 months of baseline
  • Known hypersensitivity to tetracyclines
  • Surgeries that bypass or exclude the duodenum or achlorhydria

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
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change in total inflammatory lesion count

Secondary Outcome Measures

Outcome Measure
Change from baseline in erythema scale scores
change from baseline in the investigator's global assessment (IGA) score
proportion of patients being clear or near-clear at endpoint

Collaborators and Investigators

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

Sponsor

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

June 1, 2004

Study Completion

April 1, 2005

Study Registration Dates

First Submitted

August 2, 2005

First Submitted That Met QC Criteria

August 2, 2005

First Posted (ESTIMATE)

August 4, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

August 19, 2005

Last Update Submitted That Met QC Criteria

August 18, 2005

Last Verified

August 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COL-101-ROSE-301+302

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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