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

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

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 Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: Placebo; Drug: CTX-4430

• Study Type: Interventional
• Enrollment (Actual): 124
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Australian Capital Territory
    • Phillip, Australian Capital Territory, Australia, 2606
      • Clinical Trials Woden Dermatology
  • New South Wales
    • Kogarah, New South Wales, Australia, 2217
      • St George Dermatology
    • Sydney, New South Wales, Australia, 2000
      • Central Sydney Dermatology
  • Queensland
    • Benowa, Queensland, Australia, 4217
      • The Skin Centre
    • Brisbane, Queensland, Australia, 4000
      • Siller Medical
    • Woolloongabba, Queensland, Australia, 4102
      • Veracity Clinical Research
  • Victoria
    • Carlton, Victoria, Australia, 3053
      • Skin and Cancer Foundation
  • Western Australia
    • Fremantle, Western Australia, Australia, 6160
      • Fremantle Dermatology
• New Zealand
  • Auckland, New Zealand
    • Optimal Clinical Trials
  • Hamilton, New Zealand, 3210
    • Clinical Trials New Zealand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 42 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy as measured by inflammatory lesion counts	Change from baseline in inflammatory lesion count after 12 weeks of treatment as compared to placebo.	12 weeks
Safety as measured by the incidence of treatment emergent adverse events	Incidence of treatment emergent adverse events as compared to placebo.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy as measured by Investigator Global Assessment (IGA)	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.	12 weeks
Efficacy as measured by non-inflammatory lesion counts	Change from baseline in non-inflammatory lesion counts after 12 weeks of treatment as compared to placebo.	12 weeks

Collaborators and Investigators

• Sponsor: Celtaxsys, Inc.
• Collaborators: Clinical Network Services (CNS) Pty Ltd; Celtaxsys Aus Pty Limited
• Investigators: Principal Investigator: Lynda J Spelman, MB BS, FACD, Veracity Clinical Research

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: March 5, 2015
• First Submitted That Met QC Criteria: March 5, 2015
• First Posted (Estimate): March 11, 2015

Study Record Updates

• Last Update Posted (Estimate): August 2, 2016
• Last Update Submitted That Met QC Criteria: August 1, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Facial Acne
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: CTX-4430-AV-201