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OpenTrials
Completed

NCT Number: NCT02052999

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

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

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Key information

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chung-Ang University Hospital

Seoul, 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 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

Treatment and study plan

PAC-14028 cream 1%

Drug

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

Other names: PAC-14028

Vehicle

Other

Participants received topical Vehicle twice daily for 8 weeks

Other names: Vehicle of PAC-14028 Cream

Rozex gel 0.75%

Drug

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

Primary outcomes

  1. Change in Investigator Global Assessment (IGA)

    Time frame: Baseline through Study Week 8

Secondary outcomes

  1. Erythema severity

    Time frame: Baseline through Study Week 8

  2. Telangiectasia severity

    Time frame: Baseline through Study Week 8

  3. Inflammatory lesion counts

    Time frame: Baseline through Study Week 8

Sponsors and collaborators

Lead sponsor

Amorepacific Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Feb 3, 2014
Registry last updated
Feb 3, 2014

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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