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

Rosacea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05014906
• Other study ID #: ROS001
• Status: Completed
• Phase: Phase 4
• Start date: May 2010
• Est. completion date: September 2011

Study information

• Verified date: August 2021
• Source: Dermatology Specialists Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rosacea

Intervention

Drug:
• Minocycline 45 MG
45 mg oral minocyclineonce daily vs 45mg oral minocycline once daily in combination with use of 15% azelaic acid
• Azelaic acid
45 mg oral minocyclineonce daily vs 45mg oral minocycline once daily in combination with use of 15% azelaic acid

Locations

Country	Name	City	State
United States	Dermatology Specialists	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Dermatology Specialists Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Tolerability of treatment per group	Summary of adverse events suspected as related to study medication per treatment group	12 Week
Primary	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	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
Secondary	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