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Study to Evaluate the Efficacy and Safety of PAC-14028 Cream in Rosacea Patients

Phase 2
Completed
Conditions
Erythematotelangiectatic Rosacea
Papulopustular Rosacea
Interventions
Other: Vehicle
Drug: Rozex gel 0.75%
Registration Number
NCT02052999
Lead Sponsor
Amorepacific Corporation
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

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
80
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PAC-14028 cream 1%PAC-14028 cream 1%PAC-14028 cream 1%, twice daily for 8 weeks
VehicleVehicleVehicle, twice daily for 8 weeks
Rozex gel 0.75%Rozex gel 0.75%Rozex gel 0.75%, twice daily for 8 weeks
Primary Outcome Measures
NameTimeMethod
Change in Investigator Global Assessment (IGA)Baseline through Study Week 8
Secondary Outcome Measures
NameTimeMethod
Erythema severityBaseline through Study Week 8
Telangiectasia severityBaseline through Study Week 8
Inflammatory lesion countsBaseline through Study Week 8

Trial Locations

Locations (1)

Chung-Ang University Hospital

🇰🇷

Seoul, Korea, Republic of

Chung-Ang University Hospital
🇰🇷Seoul, Korea, Republic of

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