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Completed

NCT Number: NCT02583009

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

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.

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Key information

Conditions

Rosacea Skin Diseases Skin and Connective Tissue Diseases

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Korea University Ansan Hospital

Ansan-si, Gyeonggi-do, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

PAC-14028 cream 0.1%

Drug

Topical application

PAC-14028 cream 0.3%

Drug

Topical application

PAC-14028 cream 1.0%

Drug

Topical application

PAC-14028 cream vehicle

Drug

Topical application

Primary outcomes

  1. Change in Investigator Global Assessment (IGA)

    Time frame: Week 4 from the baseline

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

Secondary outcomes

  1. Improvement rate in Investigator Global Assessment (IGA)

    Time frame: Week 4 from the baseline

  2. Change in the erythema severity score

    Time frame: Week 4 from the baseline

  3. Rate of change in inflammatory lesion counts

    Time frame: Week 4 from the baseline

  4. Change in erythema index

    Time frame: Week 4 from the baseline

  5. Change in the telangiectasia severity score

    Time frame: Week 4 from the baseline

Sponsors and collaborators

Lead sponsor

Amorepacific Corporation

Industry

Registry information

Official study title

Multicenter, Randomized, Double-blind, Placebo-controlled Parallel-group, Dose Finding Phase II Clinical Trial to Evaluate Anti Rosacea Effect and Safety of PAC-14028 Cream (0.1%, 0.3%, 1.0%) in Rosacea Patients

Important dates

Study start
2014
Primary completion
2016
First posted
Oct 21, 2015
Registry last updated
Sep 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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