Topical ASC-J9 Cream for Acne

NCT ID: NCT01289574

Last Updated: 2014-08-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

181 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2012-08-31

Brief Summary

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To evaluate the safety and efficacy of topical 0.1% and 0.025% ASC-J9 creams applied twice daily for facial acne compared to vehicle control.

Detailed Description

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Approximately 180 patients at least 12 years of age with facial acne will be randomized to twice daily topical treatment with 0.1% or 0.025% ASC-J9 cream or vehicle control for 12 weeks. Patients will return to the clinic at Weeks 2, 4, 8 and 12 and again 4 weeks after the last dose of study drug for evaluation of acne status and safety parameters.

Conditions

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Acne

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vehicle control cream

Group Type PLACEBO_COMPARATOR

ASC-J9

Intervention Type DRUG

Cream for twice daily topical application to the face

0.025% ASC-J9 cream

Group Type EXPERIMENTAL

ASC-J9

Intervention Type DRUG

Cream for twice daily topical application to the face

0.1% ASC-J9 cream

Group Type EXPERIMENTAL

ASC-J9

Intervention Type DRUG

Cream for twice daily topical application to the face

Interventions

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ASC-J9

Cream for twice daily topical application to the face

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* At least 12 years of age at the time of enrollment
* Facial acne, with:

1. 20-60 inflammatory facial lesions (papules/pustules/nodules/cysts);
2. 20-100 noninflammatory facial lesions (open and closed comedones);
3. No more than 2 nodules/cysts on the face (defined as an inflammatory lesion greater than or equal to 5 mm in diameter);
4. Investigator's Global Assessment (IGA) acne score of 3 or 4.

Exclusion Criteria

* Females who are pregnant or breast-feeding
* Skin diseases other than acne vulgaris
* Use of other topical or systemic treatments for acne
* Other significant medical conditions or clinically significant abnormal laboratory test results.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Orient Europharma Co., Ltd.

INDUSTRY

Sponsor Role collaborator

AndroScience Corp

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jonathan S Dosik, MD

Role: PRINCIPAL_INVESTIGATOR

TKL Research

Chieh-Chen Huang, MD

Role: PRINCIPAL_INVESTIGATOR

Shih Kong Wu Ho-Su Memorial Hospital

Chih-Hsun Yang, MD

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Ting-Jui Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Wan Fang Hospital

Wei-Ming Wang, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Tri-Service General Hospital

Kuo-Hsien Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Taipei Medical University Hospital

Ji-Chen Ho, MD

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital Kaohsiung Branch

Locations

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TKL Research, Inc

Paramus, New Jersey, United States

Site Status

Chang Gung Memorial Hospital

NiaoSong District, Kaohsiung City, Taiwan

Site Status

Shih Kong Wu Ho-Su Memorial Hospital

Taipei City, Taipei, Taiwan

Site Status

Tri-Service General Hospital

Taipei City, Taipei, Taiwan

Site Status

Taipei Medical University Hospital

Taipei City, Taipei, Taiwan

Site Status

Wan Fang Hospital

Taipei, Taipei, Taiwan

Site Status

Chang Gung Memorial Hospital - Linkou Branch

Gueishan Township, Taoyuan County, Taiwan

Site Status

Countries

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United States Taiwan

Other Identifiers

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ASC-J9-202

Identifier Type: -

Identifier Source: org_study_id

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