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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02385760




Registration number
NCT02385760
Ethics application status
Date submitted
5/03/2015
Date registered
11/03/2015
Date last updated
2/08/2016

Titles & IDs
Public title
CTX-4430 for the Treatment of Moderate to Severe Facial Acne Vulgaris
Scientific 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
Secondary ID [1] 0 0
CTX-4430-AV-201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acne Vulgaris 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CTX-4430
Treatment: Drugs - Placebo

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

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


Treatment: Drugs: CTX-4430


Treatment: Drugs: Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Efficacy as measured by inflammatory lesion counts
Timepoint [1] 0 0
12 weeks
Primary outcome [2] 0 0
Safety as measured by the incidence of treatment emergent adverse events
Timepoint [2] 0 0
12 weeks
Secondary outcome [1] 0 0
Efficacy as measured by Investigator Global Assessment (IGA)
Timepoint [1] 0 0
12 weeks
Secondary outcome [2] 0 0
Efficacy as measured by non-inflammatory lesion counts
Timepoint [2] 0 0
12 weeks

Eligibility
Key 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.
Minimum age
16 Years
Maximum age
44 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2016
Sample size
Target
Accrual to date
Final
124
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Clinical Trials Woden Dermatology - Phillip
Recruitment hospital [2] 0 0
St George Dermatology - Kogarah
Recruitment hospital [3] 0 0
Central Sydney Dermatology - Sydney
Recruitment hospital [4] 0 0
The Skin Centre - Benowa
Recruitment hospital [5] 0 0
Siller Medical - Brisbane
Recruitment hospital [6] 0 0
Veracity Clinical Research - Woolloongabba
Recruitment hospital [7] 0 0
Skin and Cancer Foundation - Carlton
Recruitment hospital [8] 0 0
Fremantle Dermatology - Fremantle
Recruitment postcode(s) [1] 0 0
2606 - Phillip
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2000 - Sydney
Recruitment postcode(s) [4] 0 0
4217 - Benowa
Recruitment postcode(s) [5] 0 0
4000 - Brisbane
Recruitment postcode(s) [6] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [7] 0 0
3053 - Carlton
Recruitment postcode(s) [8] 0 0
6160 - Fremantle
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Hamilton

Funding & Sponsors
Primary sponsor type
Other
Name
Celtaxsys, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Clinical Network Services (CNS) Pty Ltd
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
Celtaxsys Aus Pty Limited
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02385760
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Lynda J Spelman, MB BS, FACD
Address 0 0
Veracity Clinical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries