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

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ClinicalTrials.gov Identifier: NCT00126399
Recruitment Status : Completed
First Posted : August 4, 2005
Last Update Posted : August 19, 2005
Information provided by:
CollaGenex Pharmaceuticals

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Rosacea Drug: doxycycline Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 528 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : June 2004
Estimated Study Completion Date : April 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rosacea
U.S. FDA Resources

Primary Outcome Measures :
  1. Change in total inflammatory lesion count

Secondary Outcome Measures :
  1. Change from baseline in erythema scale scores
  2. change from baseline in the investigator's global assessment (IGA) score
  3. proportion of patients being clear or near-clear at endpoint

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

ClinicalTrials.gov Identifier: NCT00126399     History of Changes
Other Study ID Numbers: COL-101-ROSE-301+302
First Posted: August 4, 2005    Key Record Dates
Last Update Posted: August 19, 2005
Last Verified: August 2005

Keywords provided by CollaGenex Pharmaceuticals:
acne rosacea

Additional relevant MeSH terms:
Skin Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents