Clinical trial NCT02385760: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acne Vulgaris
Keywords: Facial Acne
Lead sponsor: Celtaxsys, Inc.
Sponsor class: OTHER
Collaborators: name: Clinical Network Services (CNS) Pty Ltd
name: Celtaxsys Aus Pty Limited
First posted: 2015-03-11
Enrollment: 124
Sex: ALL
Minimum age (years): 16
Maximum age (years): 44
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Efficacy as measured by inflammatory lesion counts
timeFrame: 12 weeks
measure: Safety as measured by the incidence of treatment emergent adverse events
timeFrame: 12 weeks
Secondary outcomes:
measure: Efficacy as measured by Investigator Global Assessment (IGA)
timeFrame: 12 weeks
measure: Efficacy as measured by non-inflammatory lesion counts
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Phillip
country: Australia
facility: Clinical Trials Woden Dermatology
state: Australian Capital Territory
city: Kogarah
country: Australia
facility: St George Dermatology
state: New South Wales
city: Sydney
country: Australia
facility: Central Sydney Dermatology
state: New South Wales
city: Benowa
country: Australia
facility: The Skin Centre
state: Queensland
city: Brisbane
country: Australia
facility: Siller Medical
state: Queensland
city: Woolloongabba
country: Australia
facility: Veracity Clinical Research
state: Queensland
city: Carlton
country: Australia
facility: Skin and Cancer Foundation
state: Victoria
city: Fremantle
country: Australia
facility: Fremantle Dermatology
state: Western Australia
city: Auckland
country: New Zealand
facility: Optimal Clinical Trials
city: Hamilton
country: New Zealand
facility: Clinical Trials New Zealand
Study officials:
affiliation: Veracity Clinical Research
name: Lynda J Spelman, MB BS, FACD
role: PRINCIPAL_INVESTIGATOR
References: