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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
History of Changes
  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:

MedlinePlus related topics: Rosacea
U.S. FDA Resources

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
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
Doxycycline hyclate
Anti-Bacterial Agents
Anti-Infective Agents
 Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on May 23, 2013