Topical ASC-J9 Cream for Acne

Acne Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01289574
• Other study ID #: ASC-J9-202
• Status: Completed
• Phase: Phase 2
• First received: February 2, 2011
• Last updated: July 29, 2014
• Start date: February 2011
• Est. completion date: August 2012

Study information

• Verified date: July 2014
• Source: AndroScience Corp
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: August 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne

Intervention

Drug:
• ASC-J9
Cream for twice daily topical application to the face

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital - Linkou Branch	Gueishan Township	Taoyuan County
Taiwan	Chang Gung Memorial Hospital	NiaoSong District	Kaohsiung City
Taiwan	Wan Fang Hospital	Taipei
Taiwan	Shih Kong Wu Ho-Su Memorial Hospital	Taipei City	Taipei
Taiwan	Taipei Medical University Hospital	Taipei City	Taipei
Taiwan	Tri-Service General Hospital	Taipei City	Taipei
United States	TKL Research, Inc	Paramus	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
AndroScience Corp	Orient Europharma Co., Ltd.

Countries where clinical trial is conducted

United States,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change in Inflammatory Acne Lesion Counts	Percent change from Baseline	12 weeks	No
Secondary	Success on Investigator Global Assessment (IGA) at Week 12	Overall acne rated as clear, almost clear, mild, moderate, severe, very severe.; Success = Week 12 rating of clear or almost clear and at least a 2-grade improvement from baseline	12 weeks	No
Secondary	Percent Change in Noninflammatory Acne Lesion Counts	Percent change from Baseline	12 weeks	No