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CTX-4430 for the Treatment of Moderate to Severe Facial Acne Vulgaris

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ClinicalTrials.gov Identifier: NCT02385760
Recruitment Status : Completed
First Posted : March 11, 2015
Last Update Posted : August 2, 2016
Sponsor:
Collaborators:
Clinical Network Services (CNS) Pty Ltd
Celtaxsys Aus Pty Limited
Information provided by (Responsible Party):
Celtaxsys, Inc.

Brief Summary:
A multi-centre, double-blind, randomized, parallel group, placebo controlled efficacy and safety study of oral CTX-4430 for the treatment of moderate to severe facial acne vulgaris.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: CTX-4430 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-centre, Double-blind, Randomized, Parallel Group, Placebo Controlled Efficacy and Safety Study of Oral CTX-4430 for the Treatment of Moderate to Severe Facial Acne Vulgaris
Study Start Date : April 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: Active
CTX-4430 oral capsule, 100 mg, once-daily for 12 weeks
Drug: CTX-4430
Placebo Comparator: Placebo
Placebo: identical oral capsule, without active ingredient, once-daily for 12 weeks
Drug: Placebo



Primary Outcome Measures :
  1. Efficacy as measured by inflammatory lesion counts [ Time Frame: 12 weeks ]
    Change from baseline in inflammatory lesion count after 12 weeks of treatment as compared to placebo.

  2. Safety as measured by the incidence of treatment emergent adverse events [ Time Frame: 12 weeks ]
    Incidence of treatment emergent adverse events as compared to placebo.


Secondary Outcome Measures :
  1. Efficacy as measured by Investigator Global Assessment (IGA) [ Time Frame: 12 weeks ]
    The proportion of participants achieving Grade 0 or 1 with a two grade improvement in the IGA from baseline to the end of the 12 weeks of treatment as compared to placebo.

  2. Efficacy as measured by non-inflammatory lesion counts [ Time Frame: 12 weeks ]
    Change from baseline in non-inflammatory lesion counts after 12 weeks of treatment as compared to placebo.



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Ages Eligible for Study:   16 Years to 44 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Must provide Informed consent.
  2. Male or female aged 16 to 44 inclusive.
  3. Moderate to severe facial acne vulgaris as defined in the protocol.

Exclusion Criteria:

  1. Positive testing for HIV, HBsAg, or hepatitis C virus (HCV).
  2. Females who are pregnant, lactating, or planning to become pregnant during the study.
  3. Any systemic medical condition which, in the opinion of the investigator, would put the participant at risk by participation in the study.
  4. Any systemic or dermatologic disorder that, in the opinion of the investigator will interfere with the assessment of the study endpoints (e.g. psoriasis).
  5. Concurrent or previous use of an investigational drug or device within 30 days prior to screening.
  6. The presence of acne conglobata, acne fulminans, secondary acne, or nodulocystic acne.
  7. The presence of known or suspicious unresolved dermatological cancerous or pre-cancerous lesions.
  8. Hypersensitivity or idiosyncratic reaction to compounds related to CTX-4430 or any of its components.

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): NCT02385760


Locations
Australia, Australian Capital Territory
Clinical Trials Woden Dermatology
Phillip, Australian Capital Territory, Australia, 2606
Australia, New South Wales
St George Dermatology
Kogarah, New South Wales, Australia, 2217
Central Sydney Dermatology
Sydney, New South Wales, Australia, 2000
Australia, Queensland
The Skin Centre
Benowa, Queensland, Australia, 4217
Siller Medical
Brisbane, Queensland, Australia, 4000
Veracity Clinical Research
Woolloongabba, Queensland, Australia, 4102
Australia, Victoria
Skin and Cancer Foundation
Carlton, Victoria, Australia, 3053
Australia, Western Australia
Fremantle Dermatology
Fremantle, Western Australia, Australia, 6160
New Zealand
Optimal Clinical Trials
Auckland, New Zealand
Clinical Trials New Zealand
Hamilton, New Zealand, 3210
Sponsors and Collaborators
Celtaxsys, Inc.
Clinical Network Services (CNS) Pty Ltd
Celtaxsys Aus Pty Limited
Investigators
Principal Investigator: Lynda J Spelman, MB BS, FACD Veracity Clinical Research

Responsible Party: Celtaxsys, Inc.
ClinicalTrials.gov Identifier: NCT02385760     History of Changes
Other Study ID Numbers: CTX-4430-AV-201
First Posted: March 11, 2015    Key Record Dates
Last Update Posted: August 2, 2016
Last Verified: August 2016

Keywords provided by Celtaxsys, Inc.:
Facial Acne

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