Rosacea
Conditions
Keywords
rosacea, acne rosacea
Brief summary
The objective of this study is to evaluate the safety and efficacy of 40 mg doxycycline controlled-release capsules administered once daily for the treatment of rosacea compared with a placebo.
Interventions
DRUGdoxycycline
Sponsors
CollaGenex Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: * Healthy patients with rosacea * Males and females ≥18 years of age * 10 to 40 papules and pustules and ≤2 nodules * Score of 2 to 4 on the IGA * Presence of telangiectasia * Moderate to severe erythema Main
Exclusion criteria
* Use of topical acne treatments or topical or systemic antibiotics * Use of systemic retinoids within 90 days of baseline * Use of an investigational drug within 90 days of baseline * Pregnant or nursing women * Women of childbearing potential not using an adequate form of contraception * Change in method of contraception within 4 months of baseline * Known hypersensitivity to tetracyclines * Surgeries that bypass or exclude the duodenum or achlorhydria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in total inflammatory lesion count | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in erythema scale scores | — |
| change from baseline in the investigator's global assessment (IGA) score | — |
| proportion of patients being clear or near-clear at endpoint | — |
Outcome results
None listed