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A Phase 2 Study of ASC-J9 Cream in Acne Vulgaris

NCT ID: NCT00525499

Last Updated: 2011-11-23

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

186 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2008-07-31

Brief Summary

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The purpose of this study is to evaluate if topical ASC-J9 cream is effective in treating acne.

Detailed Description

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Subjects with acne were randomized to one of four treatment groups for twice daily topical dosing to the face for 12 weeks. Assessments of acne status were performed at Baseline, Weeks 2, 4, 8 and 12 and then 4 weeks after the last dose of study drug.

Conditions

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Acne Vulgaris

Keywords

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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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1

Vehicle control cream applied topically to the face twice daily for 12 weeks

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

vehicle control applied topically twice daily for 12 weeks

2

0.001% ASC-J9 cream applied topically to the face twice daily for 12 weeks

Group Type EXPERIMENTAL

ASC-J9 cream

Intervention Type DRUG

Topical application to the face twice daily for 12 weeks.

3

0.005% ASC-J9 cream applied topically to the face twice daily for 12 weeks

Group Type EXPERIMENTAL

ASC-J9 cream

Intervention Type DRUG

Topical application to the face twice daily for 12 weeks.

4

0.025% ASC-J9 cream applied topically to the face twice daily for 12 weeks

Group Type EXPERIMENTAL

ASC-J9 cream

Intervention Type DRUG

Topical application to the face twice daily for 12 weeks.

Interventions

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ASC-J9 cream

Topical application to the face twice daily for 12 weeks.

Intervention Type DRUG

placebo

vehicle control applied topically twice daily for 12 weeks

Intervention Type DRUG

Other Intervention Names

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Androgen receptor degradation enhancer

Eligibility Criteria

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Inclusion Criteria

* At least 12 years of age.
* Facial acne, with:

20 -100 inflammatory facial lesions 20 -100 noninflammatory facial lesions No more than 2 nodules/cysts on the face

Exclusion Criteria

* Women who are pregnant or breastfeeding
* Skin diseases other than acne vulgaris
* Use of oral retinoids within 6 months of Baseline Visit
* Unwilling to discontinue all other treatments for facial acne
* Unwilling to avoid excessive swimming/sun exposure and use of cosmetics
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AndroScience Corp

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Charles CY Shih, PhD

Role: STUDY_CHAIR

AndroScience Corp

Locations

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East Bay Dermatology Medical Group

Fremont, California, United States

Site Status

Therapeutics Clinical Research

San Diego, California, United States

Site Status

Northwest Clinical Trial

Boise, Idaho, United States

Site Status

TKL Research, Inc

Paramus, New Jersey, United States

Site Status

Academic Dermatology Associates

Albuquerque, New Mexico, United States

Site Status

Dermatology Associates

Knoxville, Tennessee, United States

Site Status

DermResearch, Inc

Austin, Texas, United States

Site Status

J&S Studies, Inc

Bryan, Texas, United States

Site Status

Dermatology Research Center, Inc

Salt Lake City, Utah, United States

Site Status

Education and Research Foundation

Lynchburg, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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ASC-J9-201

Identifier Type: -

Identifier Source: org_study_id