NCT02385760

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 Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2015

Shorter than P25 for phase_2

Geographic Reach
2 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 11, 2015

Completed
21 days until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

August 2, 2016

Status Verified

August 1, 2016

Enrollment Period

1.1 years

First QC Date

March 5, 2015

Last Update Submit

August 1, 2016

Conditions

Acne Vulgaris

Keywords

Facial Acne

Outcome Measures

Primary Outcomes (2)

  • 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

  • Safety as measured by the incidence of treatment emergent adverse events

    Incidence of treatment emergent adverse events as compared to placebo.

    12 weeks

Secondary Outcomes (2)

  • Efficacy as measured by Investigator Global Assessment (IGA)

    12 weeks

  • Efficacy as measured by non-inflammatory lesion counts

    12 weeks

Study Arms (2)

Active

EXPERIMENTAL

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

Drug: CTX-4430

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

CTX-4430DRUG
Active
PlaceboDRUG
Placebo

Eligibility Criteria

Age16 Years - 44 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Must provide Informed consent.
  • Male or female aged 16 to 44 inclusive.
  • Moderate to severe facial acne vulgaris as defined in the protocol.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Clinical Trials Woden Dermatology

Phillip, Australian Capital Territory, 2606, Australia

Location

St George Dermatology

Kogarah, New South Wales, 2217, Australia

Location

Central Sydney Dermatology

Sydney, New South Wales, 2000, Australia

Location

The Skin Centre

Benowa, Queensland, 4217, Australia

Location

Siller Medical

Brisbane, Queensland, 4000, Australia

Location

Veracity Clinical Research

Woolloongabba, Queensland, 4102, Australia

Location

Skin and Cancer Foundation

Carlton, Victoria, 3053, Australia

Location

Fremantle Dermatology

Fremantle, Western Australia, 6160, Australia

Location

Optimal Clinical Trials

Auckland, New Zealand

Location

Clinical Trials New Zealand

Hamilton, 3210, New Zealand

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

acebilustat

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Study Officials

  • Lynda J Spelman, MB BS, FACD

    Veracity Clinical Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2015

First Posted

March 11, 2015

Study Start

April 1, 2015

Primary Completion

May 1, 2016

Study Completion

August 1, 2016

Last Updated

August 2, 2016

Record last verified: 2016-08

Locations

AU(8)NZ(2)