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

Study Overview
=================
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.

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

Conditions
-----------------
Rosacea

Intervention / Treatment
-----------------
* Drug: Minocycline 45 MG
* Drug: Azelaic acid


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rosacea