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

An Open Label Pilot Study to Evaluate the Efficacy of PAC-14028 in the Treatment of Erythematotelangiectatic Rosacea and Papulopustular Rosacea

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 Overview

• Status: Completed
• Conditions: Papulopustular Rosacea; Erythematotelangiectatic Rosacea
• Intervention / Treatment: Drug: PAC-14028 cream 1%; Drug: Rozex gel 0.75%; Other: Vehicle

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Chung-Ang University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: PAC-14028 cream 1%; PAC-14028 cream 1%, twice daily for 8 weeks	Drug: PAC-14028 cream 1%; Participants received topical PAC-14028 cream 1% twice daily for 8 weeks; Other Names: PAC-14028
ACTIVE_COMPARATOR: Rozex gel 0.75%; Rozex gel 0.75%, twice daily for 8 weeks	Drug: Rozex gel 0.75%; Participants received topical Rozex gel 0.75% twice daily for 8 weeks
PLACEBO_COMPARATOR: Vehicle; Vehicle, twice daily for 8 weeks	Other: Vehicle; Participants received topical Vehicle twice daily for 8 weeks; Other Names: Vehicle of PAC-14028 Cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Investigator Global Assessment (IGA)	Baseline through Study Week 8

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Amorepacific Corporation

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (ACTUAL): June 1, 2013
• Study Completion (ACTUAL): August 1, 2013

Study Registration Dates

• First Submitted: January 31, 2014
• First Submitted That Met QC Criteria: January 31, 2014
• First Posted (ESTIMATE): February 3, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): February 3, 2014
• Last Update Submitted That Met QC Criteria: January 31, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Rosacea
• Other Study ID Numbers: TRPV1-ROSACEA_IIT