NCT00525499

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
186

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 31, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 5, 2007

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

April 18, 2011

Completed
Last Updated

November 23, 2011

Status Verified

November 1, 2011

Enrollment Period

8 months

First QC Date

August 31, 2007

Results QC Date

January 31, 2011

Last Update Submit

November 16, 2011

Conditions

Acne Vulgaris

Keywords

acne

Outcome Measures

Primary Outcomes (1)

  • Percent Change in Inflammatory Acne Lesion Counts From Baseline to Week 12

    Percent change in inflammatory lesion counts from Baseline to Week 12. It is calculated by taking the Week 12 count minus the Baseline count and then dividing by the Baseline count. Thus, a negative percent change will reflect a reduction in lesion counts.

    Baseline to Week 12

Secondary Outcomes (1)

  • Number of Participants With Improvement in Investigator Global Assessment by at Least One Grade From Baseline to Week 12

    Baseline to Week 12

Study Arms (4)

1

PLACEBO COMPARATOR

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

Drug: placebo

2

EXPERIMENTAL

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

Drug: ASC-J9 cream

3

EXPERIMENTAL

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

Drug: ASC-J9 cream

4

EXPERIMENTAL

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

Drug: ASC-J9 cream

Interventions

ASC-J9 creamDRUG

Topical application to the face twice daily for 12 weeks.

234
placeboDRUG

vehicle control applied topically twice daily for 12 weeks

Also known as: Androgen receptor degradation enhancer
1

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • At least 12 years of age.
  • Facial acne, with:
  • inflammatory facial lesions 20 -100 noninflammatory facial lesions No more than 2 nodules/cysts on the face

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

East Bay Dermatology Medical Group

Fremont, California, 94538, United States

Location

Therapeutics Clinical Research

San Diego, California, 92123, United States

Location

Northwest Clinical Trial

Boise, Idaho, 83704, United States

Location

TKL Research, Inc

Paramus, New Jersey, 07652, United States

Location

Academic Dermatology Associates

Albuquerque, New Mexico, 87106, United States

Location

Dermatology Associates

Knoxville, Tennessee, 37934, United States

Location

DermResearch, Inc

Austin, Texas, 78759, United States

Location

J&S Studies, Inc

Bryan, Texas, 77802, United States

Location

Dermatology Research Center, Inc

Salt Lake City, Utah, 84124, United States

Location

Education and Research Foundation

Lynchburg, Virginia, 24501, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Results Point of Contact

Title
Charles CY Shih, PhD
Organization
AndroScience Corp
cyshih@androscience.com
(858) 638-7230

Study Officials

  • Charles CY Shih, PhD

    AndroScience Corp

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2007

First Posted

September 5, 2007

Study Start

August 1, 2007

Primary Completion

April 1, 2008

Study Completion

July 1, 2008

Last Updated

November 23, 2011

Results First Posted

April 18, 2011

Record last verified: 2011-11

Locations

US(10)