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

Papulopustular Rosacea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02052999
• Other study ID #: TRPV1-ROSACEA_IIT
• Status: Completed
• Phase: Phase 2
• First received: January 31, 2014
• Last updated: January 31, 2014
• Start date: February 2013
• Est. completion date: August 2013

Study information

• Verified date: January 2014
• Source: Amorepacific Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erythematotelangiectatic Rosacea
• Papulopustular Rosacea
• Rosacea

Intervention

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

Other:
• Vehicle
Participants received topical Vehicle twice daily for 8 weeks

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

Locations

Country	Name	City	State
Korea, Republic of	Chung-Ang University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Amorepacific Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Investigator Global Assessment (IGA)		Baseline through Study Week 8	No
Secondary	Erythema severity		Baseline through Study Week 8	No
Secondary	Telangiectasia severity		Baseline through Study Week 8	No
Secondary	Inflammatory lesion counts		Baseline through Study Week 8	No