NCT02052999CompletedPhase 2
An Open Label Pilot Study to Evaluate the Efficacy of PAC-14028 in the Treatment of Erythematotelangiectatic Rosacea and Papulopustular Rosacea
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Amorepacific Corporation
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Change in Investigator Global Assessment (IGA)
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
PAC-14028 cream 1%
Experimental
PAC-14028 cream 1%, twice daily for 8 weeks
Intervention: PAC-14028 cream 1% (Drug)
Rozex gel 0.75%
Active Comparator
Rozex gel 0.75%, twice daily for 8 weeks
Intervention: Rozex gel 0.75% (Drug)
Vehicle
Placebo Comparator
Vehicle, twice daily for 8 weeks
Intervention: Vehicle (Other)
Outcomes
Primary Outcomes
Change in Investigator Global Assessment (IGA)
Time Frame: Baseline through Study Week 8
Secondary Outcomes
- Erythema severity(Baseline through Study Week 8)
- Telangiectasia severity(Baseline through Study Week 8)
- Inflammatory lesion counts(Baseline through Study Week 8)
Investigators
Study Sites (1)
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