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

NCT ID: NCT05014906

Last Updated: 2021-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2011-09-30

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.

Conditions

Rosacea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

minocycline, azelaic acid

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

Group Type: ACTIVE_COMPARATOR

Minocycline 45 MG

Intervention Type: DRUG

45 mg oral minocyclineonce daily vs 45mg oral minocycline once daily in combination with use of 15% azelaic acid

Azelaic acid

Intervention Type: DRUG

45 mg oral minocyclineonce daily vs 45mg oral minocycline once daily in combination with use of 15% azelaic acid

azelaic acid

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

Group Type: EXPERIMENTAL

Minocycline 45 MG

Intervention Type: DRUG

45 mg oral minocyclineonce daily vs 45mg oral minocycline once daily in combination with use of 15% azelaic acid

Azelaic acid

Intervention Type: DRUG

45 mg oral minocyclineonce daily vs 45mg oral minocycline once daily in combination with use of 15% azelaic acid

Interventions

Minocycline 45 MG

45 mg oral minocyclineonce daily vs 45mg oral minocycline once daily in combination with use of 15% azelaic acid

Intervention Type: DRUG

Azelaic acid

45 mg oral minocyclineonce daily vs 45mg oral minocycline once daily in combination with use of 15% azelaic acid

Intervention Type: DRUG

Other Intervention Names

Solodyn; finacea

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dermatology Specialists Research

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James M Jackson, MD

Role: PRINCIPAL_INVESTIGATOR

Dermatology Specialists

Locations

Dermatology Specialists

Louisville, Kentucky, United States

Countries

United States

Other Identifiers

ROS001

Identifier Type: -

Identifier Source: org_study_id