Rosacea
Conditions
Keywords
rosacea
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.
Interventions
DRUGMinocycline 45 MG
45 mg oral minocyclineonce daily vs 45mg oral minocycline once daily in combination with use of 15% azelaic acid
DRUGAzelaic acid
45 mg oral minocyclineonce daily vs 45mg oral minocycline once daily in combination with use of 15% azelaic acid
Sponsors
Dermatology Specialists Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy analysis of the 12-week reduction in total lesion count | 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy analysis of the12 week reduction in IGA (Investigators Global Assessment) per treatment group | 12 Weeks | Summary of the 12-week reduction in IGA for the full sample, by treatment group |
| Efficacy analysis of the 12-week reduction in CEA (Clinical Erythema Assessment) per treatment group | 12 Weeks | Summary of the 12 week reduction in CEA for the full sample, by treatment group |
Other
| Measure | Time frame | Description |
|---|---|---|
| Tolerability of treatment per group | 12 Week | Summary of adverse events suspected as related to study medication per treatment group |
Countries
United States
Outcome results
None listed