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

Amorepacific

Status and phase: Completed; Phase 2

Conditions: Erythematotelangiectatic Rosacea; Papulopustular Rosacea

Treatments: Other: Vehicle; Drug: PAC-14028 cream 1%; Drug: Rozex gel 0.75%

Study type: Interventional

Funder types: Industry

Identifiers

NCT02052999

TRPV1-ROSACEA_IIT

Details and patient eligibility

About

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

Enrollment: 80 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 3 patient groups, including a placebo group

PAC-14028 cream 1%

Experimental group

Description:

PAC-14028 cream 1%, twice daily for 8 weeks

Treatment:

Drug: PAC-14028 cream 1%

Rozex gel 0.75%

Active Comparator group

Description:

Rozex gel 0.75%, twice daily for 8 weeks

Treatment:

Drug: Rozex gel 0.75%

Vehicle

Placebo Comparator group

Description:

Vehicle, twice daily for 8 weeks

Treatment:

Other: Vehicle