Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

TSN2898-201 Safety and Efficacy of TSN2898 in the Treatment of Acne Vulgaris

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02796066
Recruitment Status : Withdrawn (Protocol not approved)
First Posted : June 10, 2016
Last Update Posted : April 26, 2017
Sponsor:
Information provided by (Responsible Party):
Thesan Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE May 26, 2016
First Posted Date  ICMJE June 10, 2016
Last Update Posted Date April 26, 2017
Study Start Date  ICMJE June 2016
Estimated Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2016)
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02796066 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2016)
  • Non-inflammatory lesion counts [ Time Frame: 12 weeks ]
    Absolute change from Baseline
  • Absolute change from Baseline for inflammatory plus non-inflammatory lesions [ Time Frame: 12 weeks ]
  • Percent change from Baseline for inflammatory and non-inflammatory lesions [ Time Frame: 12 weeks ]
  • Investigator's Global Assessment of Acne Severity Score (IGA) [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE TSN2898-201 Safety and Efficacy of TSN2898 in the Treatment of Acne Vulgaris
Official Title  ICMJE A Phase 2, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of TSN2898 Topical Gel for the Treatment of Acne Vulgaris
Brief Summary The purpose of this study is to determine the safety and effectiveness of TSN 2898 topical gel in the treatment of moderate to severe acne.
Detailed Description TSN2898 is an inhibitor of stearoyl-CoA desaturase-1 (SCD-1), an enzyme present in sebaceous glands and a key regulatory enzyme in lipogenesis. This study will assess the safety and efficacy of TSN2898 topical gel and matched gel vehicle, applied daily on the face for the treatment of moderate to severe acne vulgaris.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • Drug: Vehicle
    Applied once a day
    Other Name: Topical gel
  • Drug: TSN2898
    Applied once a day
    Other Name: Topical gel
Study Arms  ICMJE
  • Placebo Comparator: Vehicle
    Vehicle gel
    Intervention: Drug: Vehicle
  • Experimental: Low Dose Active
    Low Dose of TSN2898
    Intervention: Drug: TSN2898
  • Experimental: Mid Dose Active
    Mid Dose of TSN2898
    Intervention: Drug: TSN2898
  • Experimental: High Dose Active
    High Dose of TSN2898
    Intervention: Drug: TSN2898
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: April 24, 2017)
0
Original Estimated Enrollment  ICMJE
 (submitted: June 6, 2016)
260
Estimated Study Completion Date  ICMJE February 2017
Estimated Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy males or females, 16 to 55 years of age
  • Must be diagnosed as having moderate or severe acne vulgaris
  • ≥ 20 inflammatory lesions on the face
  • ≥ 20 non-inflammatory lesions on the face
  • ≤ 3 nodule/cyst acne lesions
  • Medically healthy
  • Females must be of non-childbearing potential

Exclusion Criteria:

  • Systemic therapy with retinoids within six (6) months prior to study start
  • Topical use of prescription retinoids within four (4) weeks prior to study start
  • Oral antibiotics within four (4) weeks prior to study start
  • Topical dapsone, sulfacetamide, benzoyl peroxide, α-hydroxy/glycolic acid and retinol/retinaldehyde-containing products, and topical antibiotics, anti-inflammatory medications and corticosteroids on the face within two (2) weeks prior to study start
  • Facial procedures, including lasers, peels, and dermabrasion, within two (2) months prior to study start
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 55 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Dominican Republic,   Honduras,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02796066
Other Study ID Numbers  ICMJE TSN2898-201
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Thesan Pharmaceuticals, Inc.
Study Sponsor  ICMJE Thesan Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Howard Welgus, MD Thesan Pharmaceuticals
PRS Account Thesan Pharmaceuticals, Inc.
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP