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

NCT02583009 | Completed Phase 2 DMC

• 1 other identifier: AP-TRPV1_PII-03
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical study is to determine the optimum dose of PAC-14028 cream in a therapeutic confirmatory clinical study by evaluating the safety and therapeutic equivalence of PAC-14028 cream 0.1%, 0.3% and 1.0% in patients with rosacea.

Conditions

Rosacea

Outcome Measures

Primary Outcomes (1)

• Change in Investigator Global Assessment (IGA)

  Any intragroup and intergroup differences with respect to the IGA difference value on 28th day from the baseline.

  Week 4 from the baseline

Secondary Outcomes (5)

• Improvement rate in Investigator Global Assessment (IGA)

  Week 4 from the baseline

• Change in the erythema severity score

  Week 4 from the baseline

• Rate of change in inflammatory lesion counts

  Week 4 from the baseline

• Change in erythema index

  Week 4 from the baseline

• Change in the telangiectasia severity score

  Week 4 from the baseline

Study Arms (4)

PAC-14028 cream 0.1%

EXPERIMENTAL

PAC-14028 cream 0.1%, Twice daily for 4 weeks

Drug: PAC-14028 cream 0.1%

PAC-14028 cream 0.3%

EXPERIMENTAL

PAC-14028 cream 0.3%, Twice daily for 4 weeks

Drug: PAC-14028 cream 0.3%

PAC-14028 cream 1.0%

EXPERIMENTAL

PAC-14028 cream 1.0%, Twice daily for 4 weeks

Drug: PAC-14028 cream 1.0%

PAC-14028 cream vehicle

PLACEBO COMPARATOR

PAC-14028 cream vehicle, Twice daily for 4 weeks

Drug: PAC-14028 cream vehicle

Interventions

PAC-14028 cream 0.1% DRUG

Topical application

PAC-14028 cream 0.1%

PAC-14028 cream 0.3% DRUG

Topical application

PAC-14028 cream 0.3%

PAC-14028 cream 1.0% DRUG

Topical application

PAC-14028 cream 1.0%

PAC-14028 cream vehicle DRUG

Topical application

PAC-14028 cream vehicle

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients aged 19 - 70 years old
• Among the patients diagnosed with erythematotelangiectatic and papulopustular rosacea in accordance with the diagnostic criteria of the National Rosacea Society Expert Committee
• Subjects with rosacea scored 2 or more according to the Investigator Global Assessment (IGA) at screening

You may not qualify if:

• Those who can't be diagnosed or assessed for rosacea due to the presence of trauma, tattoo, scar, excessive hairs on the facial region
• Those who have received a facial laser treatment within 6 weeks
• Those who have been administered with oral retinoid or therapeutic vitamin A within 6 months
• Those who have received a hormonal treatment such as estrogen within 3 months
• Those who have been administered with systemic antibiotics or systemic steroid formulation within 4 weeks
• Those who have been administered with local retinoid, local steroid and local antibiotics and local medication for the treatment of rosacea on face within 4 weeks
• Those who have a history of blood disorder that can have a serious effect on the clinical study
• Women who are pregnant, lactating or who plan to be pregnant during the clinical study period or women of childbearing potential who do not use available contraceptive methods

Sponsors & Collaborators

• Amorepacific Corporation: lead

Study Sites (1)

Korea University Ansan Hospital

Ansan-si, Gyeonggi-do, South Korea

Location

MeSH Terms

Conditions

Rosacea

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Miyoung Park, PhD

  Amorepacific R&D Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2015
• First Posted: October 21, 2015
• Study Start: October 1, 2014
• Primary Completion: August 1, 2016
• Last Updated: September 20, 2016

Record last verified: 2016-09

Locations

KR (1)