NCT01289574

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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
181

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2011

Shorter than P25 for phase_2

Geographic Reach
2 countries

7 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

February 1, 2011

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 2, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 3, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
2 years until next milestone

Results Posted

Study results publicly available

July 25, 2014

Completed
Last Updated

August 1, 2014

Status Verified

July 1, 2014

Enrollment Period

1.4 years

First QC Date

February 2, 2011

Results QC Date

June 27, 2014

Last Update Submit

July 29, 2014

Conditions

Acne

Keywords

androgen receptor degradation enhancer

Outcome Measures

Primary Outcomes (1)

  • Percent Change in Inflammatory Acne Lesion Counts

    Percent change from Baseline

    12 weeks

Secondary Outcomes (2)

  • Success on Investigator Global Assessment (IGA) at Week 12

    12 weeks

  • Percent Change in Noninflammatory Acne Lesion Counts

    12 weeks

Study Arms (3)

Vehicle control cream

PLACEBO COMPARATOR
Drug: ASC-J9

0.025% ASC-J9 cream

EXPERIMENTAL
Drug: ASC-J9

0.1% ASC-J9 cream

EXPERIMENTAL
Drug: ASC-J9

Interventions

ASC-J9DRUG

Cream for twice daily topical application to the face

0.025% ASC-J9 cream0.1% ASC-J9 creamVehicle control cream

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 at the time of enrollment
  • Facial acne, with:
  • inflammatory facial lesions (papules/pustules/nodules/cysts);
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

TKL Research, Inc

Paramus, New Jersey, 07652, United States

Location

Chang Gung Memorial Hospital

NiaoSong District, Kaohsiung City, Taiwan

Location

Shih Kong Wu Ho-Su Memorial Hospital

Taipei City, Taipei, 11160, Taiwan

Location

Tri-Service General Hospital

Taipei City, Taipei, 11490, Taiwan

Location

Taipei Medical University Hospital

Taipei City, Taipei, Taiwan

Location

Wan Fang Hospital

Taipei, Taipei, 11696, Taiwan

Location

Chang Gung Memorial Hospital - Linkou Branch

Gueishan Township, Taoyuan County, 33305, Taiwan

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

1,7-bis(4-hydroxy-3-methoxyphenyl)-1,4,6-heptatrien-3-one

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

  • Jonathan S Dosik, MD

    TKL Research

    PRINCIPAL INVESTIGATOR

  • Chieh-Chen Huang, MD

    Shih Kong Wu Ho-Su Memorial Hospital

    PRINCIPAL INVESTIGATOR

  • Chih-Hsun Yang, MD

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

  • Ting-Jui Chen, MD

    Wan Fang Hospital

    PRINCIPAL INVESTIGATOR

  • Wei-Ming Wang, MD PhD

    Tri-Service General Hospital

    PRINCIPAL INVESTIGATOR

  • Kuo-Hsien Wang, MD

    Taipei Medical University Hospital

    PRINCIPAL INVESTIGATOR

  • Ji-Chen Ho, MD

    Chang Gung Memorial Hospital Kaohsiung Branch

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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

February 2, 2011

First Posted

February 3, 2011

Study Start

February 1, 2011

Primary Completion

July 1, 2012

Study Completion

August 1, 2012

Last Updated

August 1, 2014

Results First Posted

July 25, 2014

Record last verified: 2014-07

Locations

TW(6)US(1)