Clinical trial NCT01289574: Topical ASC-J9 Cream for Acne
Official title: Phase 2, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled Clinical Study to Evaluate the Safety and Efficacy of 0.1% and 0.025% ASC-J9 Creams Applied Topically Twice Daily for 12 Weeks for the Treatment of Facial Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acne
Keywords: androgen receptor degradation enhancer
Lead sponsor: AndroScience Corp
Sponsor class: INDUSTRY
Collaborators: name: Orient Europharma Co., Ltd.
First posted: 2011-02-03
Enrollment: 181
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Key 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.

Key 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.

Primary outcomes:
measure: Percent Change in Inflammatory Acne Lesion Counts
timeFrame: 12 weeks
Secondary outcomes:
measure: Success on Investigator Global Assessment (IGA) at Week 12
timeFrame: 12 weeks
measure: Percent Change in Noninflammatory Acne Lesion Counts
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Paramus
country: United States
facility: TKL Research, Inc
state: New Jersey
city: NiaoSong District
country: Taiwan
facility: Chang Gung Memorial Hospital
state: Kaohsiung City
city: Taipei City
country: Taiwan
facility: Shih Kong Wu Ho-Su Memorial Hospital
state: Taipei
city: Taipei City
country: Taiwan
facility: Tri-Service General Hospital
state: Taipei
city: Taipei City
country: Taiwan
facility: Taipei Medical University Hospital
state: Taipei
city: Gueishan Township
country: Taiwan
facility: Chang Gung Memorial Hospital - Linkou Branch
state: Taoyuan County
city: Taipei
country: Taiwan
facility: Wan Fang Hospital
Study officials:
affiliation: TKL Research
name: Jonathan S Dosik, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shih Kong Wu Ho-Su Memorial Hospital
name: Chieh-Chen Huang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chang Gung Memorial Hospital
name: Chih-Hsun Yang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wan Fang Hospital
name: Ting-Jui Chen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tri-Service General Hospital
name: Wei-Ming Wang, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Taipei Medical University Hospital
name: Kuo-Hsien Wang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chang Gung Memorial Hospital Kaohsiung Branch
name: Ji-Chen Ho, MD
role: PRINCIPAL_INVESTIGATOR
References: