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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| minocycline, azelaic acid | Active Comparator | minocycline vs minocycline in comination with 15% azelaic acid for treatment of rosacea |
|
| azelaic acid | Experimental | 45 mg oral minocycline vs 45 mg oral minocycline plus 15% azelaic acid in the treatment of facial rosacea |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minocycline 45 MG | Drug | 45 mg oral minocyclineonce daily vs 45mg oral minocycline once daily in combination with use of 15% azelaic acid |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability of treatment per group | Summary of adverse events suspected as related to study medication per treatment group | 12 Week |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James M Jackson, MD | Dermatology Specialists | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology Specialists | Louisville | Kentucky | 40202 | United States |
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| ID | Term |
|---|---|
| D012393 | Rosacea |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D008911 | Minocycline |
| C010038 | azelaic acid |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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|
| Azelaic acid | Drug | 45 mg oral minocyclineonce daily vs 45mg oral minocycline once daily in combination with use of 15% azelaic acid |
|
|
Summary of the 12 week reduction in CEA for the full sample, by treatment group |
| 12 Weeks |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |