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

Acne Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02385760
• Other study ID #: CTX-4430-AV-201
• Status: Completed
• Phase: Phase 2
• First received: March 5, 2015
• Last updated: August 1, 2016
• Start date: April 2015
• Est. completion date: August 2016

Study information

• Verified date: August 2016
• Source: Celtaxsys, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationNew Zealand: Medsafe
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: August 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 44 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• CTX-4430

• Placebo

Locations

Country	Name	City	State
Australia	The Skin Centre	Benowa	Queensland
Australia	Siller Medical	Brisbane	Queensland
Australia	Skin and Cancer Foundation	Carlton	Victoria
Australia	Fremantle Dermatology	Fremantle	Western Australia
Australia	St George Dermatology	Kogarah	New South Wales
Australia	Clinical Trials Woden Dermatology	Phillip	Australian Capital Territory
Australia	Central Sydney Dermatology	Sydney	New South Wales
Australia	Veracity Clinical Research	Woolloongabba	Queensland
New Zealand	Optimal Clinical Trials	Auckland
New Zealand	Clinical Trials New Zealand	Hamilton

Sponsors (3)

Lead Sponsor	Collaborator
Celtaxsys, Inc.	Celtaxsys Aus Pty Limited, Clinical Network Services (CNS) Pty Ltd

Countries where clinical trial is conducted

Australia,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Safety as measured by the incidence of treatment emergent adverse events	Incidence of treatment emergent adverse events as compared to placebo.	12 weeks	Yes
Secondary	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	No
Secondary	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	No