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

Dermatology Specialists Research

Status and phase: Completed; Phase 4

Conditions: Rosacea

Treatments: Drug: Azelaic acid; Drug: Minocycline 45 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT05014906

ROS001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

minocycline, azelaic acid

Active Comparator group

Description:

minocycline vs minocycline in comination with 15% azelaic acid for treatment of rosacea

Treatment:

Drug: Minocycline 45 MG

Drug: Azelaic acid

azelaic acid

Experimental group

Description:

45 mg oral minocycline vs 45 mg oral minocycline plus 15% azelaic acid in the treatment of facial rosacea

Treatment:

Drug: Minocycline 45 MG

Drug: Azelaic acid