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

This study has been completed.
Sponsor:
Information provided by:
CollaGenex Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00126399
First received: August 2, 2005
Last updated: August 18, 2005
Last verified: August 2005
  Purpose

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 Intervention Phase
Rosacea
Drug: doxycycline
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by CollaGenex Pharmaceuticals:

Primary Outcome Measures:
  • Change in total inflammatory lesion count

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 528
Study Start Date: June 2004
Estimated Study Completion Date: April 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00126399     History of Changes
Other Study ID Numbers: COL-101-ROSE-301+302
Study First Received: August 2, 2005
Last Updated: August 18, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by CollaGenex Pharmaceuticals:
rosacea
acne rosacea

Additional relevant MeSH terms:
Rosacea
Skin Diseases
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014