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

NCT02052999 | Completed Phase 2 DMC

• 1 other identifier: TRPV1-ROSACEA_IIT
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Erythematotelangiectatic Rosacea; Papulopustular Rosacea

Outcome Measures

Primary Outcomes (1)

• Change in Investigator Global Assessment (IGA)

  Baseline through Study Week 8

Secondary Outcomes (3)

• Erythema severity

  Baseline through Study Week 8

• Telangiectasia severity

  Baseline through Study Week 8

• Inflammatory lesion counts

  Baseline through Study Week 8

Study Arms (3)

PAC-14028 cream 1%

EXPERIMENTAL

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

Drug: PAC-14028 cream 1%

Rozex gel 0.75%

ACTIVE COMPARATOR

Rozex gel 0.75%, twice daily for 8 weeks

Drug: Rozex gel 0.75%

Vehicle

PLACEBO COMPARATOR

Vehicle, twice daily for 8 weeks

Other: Vehicle

Interventions

PAC-14028 cream 1% DRUG

Participants received topical PAC-14028 cream 1% twice daily for 8 weeks

Also known as: PAC-14028

PAC-14028 cream 1%

Vehicle OTHER

Participants received topical Vehicle twice daily for 8 weeks

Also known as: Vehicle of PAC-14028 Cream

Vehicle

Rozex gel 0.75% DRUG

Participants received topical Rozex gel 0.75% twice daily for 8 weeks

Rozex gel 0.75%

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amorepacific Corporation: lead

Study Sites (1)

Chung-Ang University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Rosacea

Interventions

N-(1-(3,5-difluoro-4-methanesulfonylaminophenyl)ethyl)-3-(2-propyl-6-trifluoromethylpyridine-3-yl)acrylamide

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• BeomJoon Kim, Professor

  Department of Dermatology, Chungang University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2014
• First Posted: February 3, 2014
• Study Start: February 1, 2013
• Primary Completion: June 1, 2013
• Study Completion: August 1, 2013
• Last Updated: February 3, 2014

Record last verified: 2014-01

Locations

KR (1)