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Completed

NCT Number: NCT01289574

Topical ASC-J9 Cream for Acne

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.

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Key information

Conditions

Acne Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chang Gung Memorial Hospital, NiaoSong District, Kaohsiung City, Taiwan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ASC-J9

Drug

Cream for twice daily topical application to the face

Primary outcomes

  1. Percent Change in Inflammatory Acne Lesion Counts

    Time frame: 12 weeks

    Percent change from Baseline

Secondary outcomes

  1. Success on Investigator Global Assessment (IGA) at Week 12

    Time frame: 12 weeks

    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

  2. Percent Change in Noninflammatory Acne Lesion Counts

    Time frame: 12 weeks

    Percent change from Baseline

Sponsors and collaborators

Lead sponsor

AndroScience Corp

Industry

Collaborators

  • Orient Europharma Co., Ltd.

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 3, 2011
Registry last updated
Aug 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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