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

Phase 4

Completed

• Conditions: Rosacea
• Interventions: Drug: Minocycline 45 MG; Drug: Azelaic acid

• Registration Number: NCT05014906
• Lead Sponsor: Dermatology Specialists Research

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2010-05
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Study First Submitted: 2013-11-22
• Status Verified: 2021-08
• Study First Submitted QC: 2021-08-13
• Last Update Submitted: 2021-08-13
• Study First Posted: 2021-08-20
• Last Update Posted: 2021-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
azelaic acid	Minocycline 45 MG	45 mg oral minocycline vs 45 mg oral minocycline plus 15% azelaic acid in the treatment of facial rosacea
minocycline, azelaic acid	Minocycline 45 MG	minocycline vs minocycline in comination with 15% azelaic acid for treatment of rosacea
azelaic acid	Azelaic acid	45 mg oral minocycline vs 45 mg oral minocycline plus 15% azelaic acid in the treatment of facial rosacea
minocycline, azelaic acid	Azelaic acid	minocycline vs minocycline in comination with 15% azelaic acid for treatment of rosacea

Primary Outcome Measures

Name	Time	Method
Efficacy analysis of the 12-week reduction in total lesion count	12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Efficacy analysis of the12 week reduction in IGA (Investigators Global Assessment) per treatment group	12 Weeks	Summary of the 12-week reduction in IGA for the full sample, by treatment group
Efficacy analysis of the 12-week reduction in CEA (Clinical Erythema Assessment) per treatment group	12 Weeks	Summary of the 12 week reduction in CEA for the full sample, by treatment group

Trial Locations

Locations (1)

Dermatology Specialists; 🇺🇸 Louisville, Kentucky, United States