search
Back to results

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

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CTX-4430
Placebo
Sponsored by
Celtaxsys, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring Facial Acne

Eligibility Criteria

16 Years - 44 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Clinical Trials Woden Dermatology
  • St George Dermatology
  • Central Sydney Dermatology
  • The Skin Centre
  • Siller Medical
  • Veracity Clinical Research
  • Skin and Cancer Foundation
  • Fremantle Dermatology
  • Optimal Clinical Trials
  • Clinical Trials New Zealand

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active

Placebo

Arm Description

CTX-4430 oral capsule, 100 mg, once-daily for 12 weeks

Placebo: identical oral capsule, without active ingredient, once-daily for 12 weeks

Outcomes

Primary Outcome Measures

Efficacy as measured by inflammatory lesion counts
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
Incidence of treatment emergent adverse events as compared to placebo.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
March 5, 2015
Last Updated
August 1, 2016
Sponsor
Celtaxsys, Inc.
Collaborators
Clinical Network Services (CNS) Pty Ltd, Celtaxsys Aus Pty Limited
search

1. Study Identification

Unique Protocol Identification Number
NCT02385760
Brief Title
CTX-4430 for the Treatment of Moderate to Severe Facial Acne Vulgaris
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 Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celtaxsys, Inc.
Collaborators
Clinical Network Services (CNS) Pty Ltd, Celtaxsys Aus Pty Limited

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
Facial Acne

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Experimental
Arm Description
CTX-4430 oral capsule, 100 mg, once-daily for 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo: identical oral capsule, without active ingredient, once-daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
CTX-4430
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Efficacy as measured by inflammatory lesion counts
Description
Change from baseline in inflammatory lesion count after 12 weeks of treatment as compared to placebo.
Time Frame
12 weeks
Title
Safety as measured by the incidence of treatment emergent adverse events
Description
Incidence of treatment emergent adverse events as compared to placebo.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Efficacy as measured by Investigator Global Assessment (IGA)
Description
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.
Time Frame
12 weeks
Title
Efficacy as measured by non-inflammatory lesion counts
Description
Change from baseline in non-inflammatory lesion counts after 12 weeks of treatment as compared to placebo.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Must provide Informed consent. Male or female aged 16 to 44 inclusive. Moderate to severe facial acne vulgaris as defined in the protocol. Exclusion Criteria: Positive testing for HIV, HBsAg, or hepatitis C virus (HCV). Females who are pregnant, lactating, or planning to become pregnant during the study. Any systemic medical condition which, in the opinion of the investigator, would put the participant at risk by participation in the study. Any systemic or dermatologic disorder that, in the opinion of the investigator will interfere with the assessment of the study endpoints (e.g. psoriasis). Concurrent or previous use of an investigational drug or device within 30 days prior to screening. The presence of acne conglobata, acne fulminans, secondary acne, or nodulocystic acne. The presence of known or suspicious unresolved dermatological cancerous or pre-cancerous lesions. Hypersensitivity or idiosyncratic reaction to compounds related to CTX-4430 or any of its components.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lynda J Spelman, MB BS, FACD
Organizational Affiliation
Veracity Clinical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Trials Woden Dermatology
City
Phillip
State/Province
Australian Capital Territory
ZIP/Postal Code
2606
Country
Australia
Facility Name
St George Dermatology
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Central Sydney Dermatology
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2000
Country
Australia
Facility Name
The Skin Centre
City
Benowa
State/Province
Queensland
ZIP/Postal Code
4217
Country
Australia
Facility Name
Siller Medical
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4000
Country
Australia
Facility Name
Veracity Clinical Research
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Skin and Cancer Foundation
City
Carlton
State/Province
Victoria
ZIP/Postal Code
3053
Country
Australia
Facility Name
Fremantle Dermatology
City
Fremantle
State/Province
Western Australia
ZIP/Postal Code
6160
Country
Australia
Facility Name
Optimal Clinical Trials
City
Auckland
Country
New Zealand
Facility Name
Clinical Trials New Zealand
City
Hamilton
ZIP/Postal Code
3210
Country
New Zealand

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs