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

CollaGenex

Status and phase: Completed; Phase 3

Conditions: Rosacea

Treatments: Drug: doxycycline

Study type: Interventional

Funder types: Industry

Identifiers

NCT00126399

COL-101-ROSE-301+302

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind