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

Phase 2

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: CTX-4430; Drug: Placebo

• Registration Number: NCT02385760
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-05
• Study First Submitted QC: 2015-03-05
• Study First Posted: 2015-03-11
• Study Start: 2015-04
• Primary Completion: 2016-05
• Status Verified: 2016-08
• Study Completion: 2016-08
• Last Update Submitted: 2016-08-01
• Last Update Posted: 2016-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active	CTX-4430	CTX-4430 oral capsule, 100 mg, once-daily for 12 weeks
Placebo	Placebo	Placebo: identical oral capsule, without active ingredient, once-daily for 12 weeks

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (10)

Central Sydney Dermatology; 🇦🇺 Sydney, New South Wales, Australia

Fremantle Dermatology; 🇦🇺 Fremantle, Western Australia, Australia

Optimal Clinical Trials; 🇳🇿 Auckland, New Zealand

Siller Medical; 🇦🇺 Brisbane, Queensland, Australia

The Skin Centre; 🇦🇺 Benowa, Queensland, Australia

Veracity Clinical Research; 🇦🇺 Woolloongabba, Queensland, Australia

Clinical Trials New Zealand; 🇳🇿 Hamilton, New Zealand

Clinical Trials Woden Dermatology; 🇦🇺 Phillip, Australian Capital Territory, Australia

Skin and Cancer Foundation; 🇦🇺 Carlton, Victoria, Australia

St George Dermatology; 🇦🇺 Kogarah, New South Wales, Australia