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Completed

NCT Number: NCT02385760

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

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.

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

16 year–44 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Clinical Trials Woden Dermatology, Phillip, Australian Capital Territory, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CTX-4430

Drug

Placebo

Drug

Primary outcomes

  1. Efficacy as measured by inflammatory lesion counts

    Time frame: 12 weeks

    Change from baseline in inflammatory lesion count after 12 weeks of treatment as compared to placebo.

  2. Safety as measured by the incidence of treatment emergent adverse events

    Time frame: 12 weeks

    Incidence of treatment emergent adverse events as compared to placebo.

Secondary outcomes

  1. Efficacy as measured by Investigator Global Assessment (IGA)

    Time frame: 12 weeks

    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.

  2. Efficacy as measured by non-inflammatory lesion counts

    Time frame: 12 weeks

    Change from baseline in non-inflammatory lesion counts after 12 weeks of treatment as compared to placebo.

Sponsors and collaborators

Lead sponsor

Celtaxsys, Inc.

Other

Collaborators

  • Celtaxsys Aus Pty Limited
  • Clinical Network Services (CNS) Pty Ltd

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 11, 2015
Registry last updated
Aug 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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