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

CollaGenex Pharmaceuticals528 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

528

Conditions

Rosacea

Interventions

doxycyclineDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

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

Data from ClinicalTrials.gov

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