Efficacy of Oral Minocycline (Solodyn) and Oral Minocycline (Solodyn) Plus Azelaic Acid (Finacea) for Acne Rosacea

Dermatology Specialists Research60 enrolled

Overview

Rosacea is one of the most commonly occurring dermatoses treated by dermatologist today. Rosacea is an inflammatory condition of the skin presenting as flushing and or blushing along with redness, swelling, telangiectasia, and acne lesions. Minocycline has shown beneficial in the treatment of inflammatory acne lesions in patients with rosacea. This study is to evaluate the efficacy and tolerability of minocycline (Solodyn) alone versus minocycline (Solodyn) in combination with azelaic acid 15%(Finacea) in the treatment of rosacea.

This is a multicenter, randomized, outpatient, Investigator-blind study of minocycline 45 mg and minocycline 45 mg plus 15% azelaic acid for the treatment of rosacea.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

Conditions

Rosacea

Interventions

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * age 18 or older with clinical diagnosis of rosacea * must have 10-40 facial inflammatory lesions and less than 2 nodules * women of child bearing potential must be non lactating * must have negative urine pregnancy test * must use effective form of birth control Exclusion Criteria: * The use of systemic antibiotics within 30 days of study start * the use of topical medications within 14 - 30 days of study start depending on type of topical medication * Patients with known sensitivity to tetracyclines * Patients who have had gastric bypass surgery or are considered achlorhydric * Patients taking drugs known as photosensitizers

Outcomes

Primary Outcomes

Efficacy analysis of the 12-week reduction in total lesion count

The goal of analysis is to assess evidence of overall effect of 45mg minocycline and overall effect of 45 mg minocycline plus 15% azelaic acid in therapy of patients with acne rosacea.

Time frame: 12 weeks

Secondary Outcomes

Efficacy analysis of the12 week reduction in IGA (Investigators Global Assessment) per treatment group

Summary of the 12-week reduction in IGA for the full sample, by treatment group

Time frame: 12 Weeks

Efficacy analysis of the 12-week reduction in CEA (Clinical Erythema Assessment) per treatment group

Summary of the 12 week reduction in CEA for the full sample, by treatment group