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

Efficacy of 45mg Oral Minocycline (Solodyn) and 45mg Oral Minocycline (Solodyn) Plus 15% Azelaic Acid (Finacea) in the Treatment of Acne Rosacea

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.

Study Overview

• Status: Completed
• Conditions: Rosacea
• Intervention / Treatment: Drug: Minocycline 45 MG; Drug: Azelaic acid

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Dermatology Specialists

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: minocycline, azelaic acid; minocycline vs minocycline in comination with 15% azelaic acid for treatment of rosacea	Drug: Minocycline 45 MG; 45 mg oral minocyclineonce daily vs 45mg oral minocycline once daily in combination with use of 15% azelaic acid; Other Names: Solodyn; Drug: Azelaic acid; 45 mg oral minocyclineonce daily vs 45mg oral minocycline once daily in combination with use of 15% azelaic acid; Other Names: finacea
Experimental: azelaic acid; 45 mg oral minocycline vs 45 mg oral minocycline plus 15% azelaic acid in the treatment of facial rosacea	Drug: Minocycline 45 MG; 45 mg oral minocyclineonce daily vs 45mg oral minocycline once daily in combination with use of 15% azelaic acid; Other Names: Solodyn; Drug: Azelaic acid; 45 mg oral minocyclineonce daily vs 45mg oral minocycline once daily in combination with use of 15% azelaic acid; Other Names: finacea

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	12 Weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tolerability of treatment per group	Summary of adverse events suspected as related to study medication per treatment group	12 Week

Collaborators and Investigators

• Sponsor: Dermatology Specialists Research
• Investigators: Principal Investigator: James M Jackson, MD, Dermatology Specialists

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: November 22, 2013
• First Submitted That Met QC Criteria: August 13, 2021
• First Posted (Actual): August 20, 2021

Study Record Updates

• Last Update Posted (Actual): August 20, 2021
• Last Update Submitted That Met QC Criteria: August 13, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: rosacea
• Additional Relevant MeSH Terms: Skin Diseases; Rosacea; Anti-Infective Agents; Antineoplastic Agents; Dermatologic Agents; Anti-Bacterial Agents; Azelaic acid; Minocycline
• Other Study ID Numbers: ROS001