Clinical trial NCT02052999: Study to Evaluate the Efficacy and Safety of PAC-14028 Cream in Rosacea Patients
Official title: An Open Label Pilot Study to Evaluate the Efficacy of PAC-14028 in the Treatment of Erythematotelangiectatic Rosacea and Papulopustular Rosacea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Erythematotelangiectatic Rosacea
Papulopustular Rosacea
Lead sponsor: Amorepacific Corporation
Sponsor class: INDUSTRY
First posted: 2014-02-03
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Change in Investigator Global Assessment (IGA)
timeFrame: Baseline through Study Week 8
Secondary outcomes:
measure: Erythema severity
timeFrame: Baseline through Study Week 8
measure: Telangiectasia severity
timeFrame: Baseline through Study Week 8
measure: Inflammatory lesion counts
timeFrame: Baseline through Study Week 8
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
Study officials:
affiliation: Department of Dermatology, Chungang University Hospital
name: BeomJoon Kim, Professor
role: PRINCIPAL_INVESTIGATOR
References: