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

Further Study Details: 

Primary Outcomes: Change in total inflammatory lesion count
Secondary Outcomes: 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
Expected Total Enrollment:  528

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Study ID Numbers:  COL-101-ROSE-301+302
Last Updated:  August 18, 2005
Record first received:  August 2, 2005
ClinicalTrials.gov Identifier:  NCT00126399
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-23