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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01289574
Other study ID # ASC-J9-202
Secondary ID
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


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
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