Back to results

Topical ASC-J9 Cream for Acne

Primary Purpose

Acne

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

ASC-J9

About this trial

This is an interventional treatment trial for Acne focused on measuring androgen receptor degradation enhancer

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

TKL Research, Inc
Chang Gung Memorial Hospital
Shih Kong Wu Ho-Su Memorial Hospital
Tri-Service General Hospital
Taipei Medical University Hospital
Chang Gung Memorial Hospital - Linkou Branch
Wan Fang Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

Vehicle control cream

0.025% ASC-J9 cream

0.1% ASC-J9 cream

Arm Description

Outcomes

Primary Outcome Measures

Percent Change in Inflammatory Acne Lesion Counts

Percent change from Baseline

Secondary Outcome Measures

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

Percent Change in Noninflammatory Acne Lesion Counts

Percent change from Baseline

Full Information

NCT ID

NCT01289574

First Posted

February 2, 2011

Last Updated

July 29, 2014

Sponsor

AndroScience Corp

Collaborators

Orient Europharma Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01289574

Brief Title

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

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Completed

Study Start Date

February 2011 (undefined)

Primary Completion Date

July 2012 (Actual)

Study Completion Date

August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AndroScience Corp

Collaborators

Orient Europharma Co., Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acne

Keywords

androgen receptor degradation enhancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

181 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vehicle control cream

Arm Type

Placebo Comparator

Arm Title

0.025% ASC-J9 cream

Arm Type

Experimental

Arm Title

0.1% ASC-J9 cream

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

ASC-J9

Intervention Description

Cream for twice daily topical application to the face

Primary Outcome Measure Information:

Title

Percent Change in Inflammatory Acne Lesion Counts

Description

Percent change from Baseline

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Success on Investigator Global Assessment (IGA) at Week 12

Description

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

Time Frame

12 weeks

Title

Percent Change in Noninflammatory Acne Lesion Counts

Description

Percent change from Baseline

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: At least 12 years of age at the time of enrollment Facial acne, with: 20-60 inflammatory facial lesions (papules/pustules/nodules/cysts); 20-100 noninflammatory facial lesions (open and closed comedones); No more than 2 nodules/cysts on the face (defined as an inflammatory lesion greater than or equal to 5 mm in diameter); 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.

Overall Study Officials: