Erythematotelangiectatic Rosacea, Papulopustular Rosacea
Conditions
Brief summary
The objective of this study is to determine the efficacy and safety of PAC-14028 1% cream of Amorepacific Corporation in patients with erythema-telangiectatic or papulopustular rosacea
Interventions
DRUGPAC-14028 cream 1%
Participants received topical PAC-14028 cream 1% twice daily for 8 weeks
OTHERVehicle
Participants received topical Vehicle twice daily for 8 weeks
DRUGRozex gel 0.75%
Participants received topical Rozex gel 0.75% twice daily for 8 weeks
Sponsors
Amorepacific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male and female patients at the age of 20 to 65 years old * Clinical diagnosis of erythematotelangiectatic or papulopustular rosacea according to National Rosacea Committee Expert Society with * Erythema severity ≥ 1 * Telangiectasia severity ≥ 1 * At least 3 papules or pustules in facial region * IGA score ≥ 2 * Voluntarily signed written informed consent forms for study participation
Exclusion criteria
* Patients who are unable to be diagnosed or evaluated for rosacea due to tattoo or scar in the facial area * Patients who are unable to be diagnosed or evaluated for rosacea due to excess hair(e.g., mustache, beard, whiskers etc.) in the facial area * Patients who are sensitive to the drug or vehicle * Previous administration of oral retinoid or vitamin A(≥10,000 units/day) within 6 months prior to visit 1 * Previous use of estrogen or oral contraceptives within 3 months prior to visit 1 * Previous use of topical retinoids or oral antibiotics (e.g., tetracycline, tetracycline derivatives, erythromycin, erythromycin derivatives, sulfamethoxazole, trimethoprim) or oral steroid for the treatment of facial rosacea within 1 month prior to visit 1 * Previous use of topical steroid or topical antibiotics, topical treatment for rosacea(e.g., metronidazole, azelaic acid) within 2 weeks prior to visit 1 * Presently undergoing anti-coagulant therapies * History of hematologic disease * Ocular-only, Phymatous rosacea, or papulopustular rosacea patients who require systemic antibiotics * History of laser treatment for rosacea within 6 weeks prior to visit 1 * Alcoholic or drug abuse patients * Patients who are treated with prohibited concomitant drugs or considered to inevitably require treatment with prohibited concomitant drugs during the study period * Renal function impairment with creatinine level higher than twice of maximum normal range * Hepatic function impairment with AST/ALT higher than twice of maximum normal range * Pregnant and lactating woman, woman with child-birth potential(should have negative pregnancy test at the baseline visit of the study) * Participation in another clinical study within 1 month prior to screening * Patients considered ineligible for study participation by the principal investigator or sub-investigator for other reasons; rosacea due to other medical (liver disease, renal failure, etc.), psychotic, or neuropathic causes rather than as a skin disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Investigator Global Assessment (IGA) | Baseline through Study Week 8 |
Secondary
| Measure | Time frame |
|---|---|
| Erythema severity | Baseline through Study Week 8 |
| Telangiectasia severity | Baseline through Study Week 8 |
| Inflammatory lesion counts | Baseline through Study Week 8 |
Countries
South Korea
Outcome results
None listed