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.

First Received on August 2, 2005. Last Updated on August 18, 2005 History of Changes

Sponsor:	CollaGenex Pharmaceuticals
Information provided by:	CollaGenex Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00126399

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 III

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

Drug Information available for: Doxycycline Doxycycline hyclate Doxycycline calcium

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 February 12, 2012