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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Recruitment Status : Withdrawn (Protocol not approved)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.

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.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: Vehicle Drug: TSN2898 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2016
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Placebo Comparator: Vehicle
Vehicle gel
Drug: Vehicle
Applied once a day
Other Name: Topical gel

Experimental: Low Dose Active
Low Dose of TSN2898
Drug: TSN2898
Applied once a day
Other Name: Topical gel

Experimental: Mid Dose Active
Mid Dose of TSN2898
Drug: TSN2898
Applied once a day
Other Name: Topical gel

Experimental: High Dose Active
High Dose of TSN2898
Drug: TSN2898
Applied once a day
Other Name: Topical gel




Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Non-inflammatory lesion counts [ Time Frame: 12 weeks ]
    Absolute change from Baseline

  2. Absolute change from Baseline for inflammatory plus non-inflammatory lesions [ Time Frame: 12 weeks ]
  3. Percent change from Baseline for inflammatory and non-inflammatory lesions [ Time Frame: 12 weeks ]
  4. Investigator's Global Assessment of Acne Severity Score (IGA) [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02796066


Locations
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United States, California
Thesan Site 4
San Diego, California, United States, 92123
United States, Florida
Thesan Site 3
Miami, Florida, United States, 33144
United States, North Carolina
Thesan Site 6
High Point, North Carolina, United States, 27626
United States, Rhode Island
Thesan Site 5
Johnston, Rhode Island, United States, 02919
Dominican Republic
Thesan Site 2
Santo Domingo, Dominican Republic
Honduras
Thesan Site 1
San Pedro Sula, Honduras
Sponsors and Collaborators
Thesan Pharmaceuticals, Inc.
Investigators
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Study Director: Howard Welgus, MD Thesan Pharmaceuticals

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Responsible Party: Thesan Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02796066     History of Changes
Other Study ID Numbers: TSN2898-201
First Posted: June 10, 2016    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Thesan Pharmaceuticals, Inc.:
Acne, topical, SCD-1 inhibitor, moderate, severe

Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases