Acne VulgarisPhase 2NCT02385760
CTX-4430 for the Treatment of Moderate to Severe Facial Acne Vulgaris
A Phase 2 study testing CTX-4430 in people with Acne Vulgaris, run by Celtaxsys, Inc. at 10 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 44 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- CTX-4430
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Apr 2015to Aug 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 44 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Must provide Informed consent.
- Male or female aged 16 to 44 inclusive.
- Moderate to severe facial acne vulgaris as defined in the protocol.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
Australia8 sites
The Skin Centre
Benowa, Queensland, 4217
Siller Medical
Brisbane, Queensland, 4000
Skin and Cancer Foundation
Carlton, Victoria, 3053
Fremantle Dermatology
Fremantle, Western Australia, 6160
St George Dermatology
Kogarah, New South Wales, 2217
Clinical Trials Woden Dermatology
Phillip, Australian Capital Territory, 2606
Central Sydney Dermatology
Sydney, New South Wales, 2000
Veracity Clinical Research
Woolloongabba, Queensland, 4102
New Zealand2 sites
Optimal Clinical Trials
Auckland
Clinical Trials New Zealand
Hamilton, 3210
About this study
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
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.
- Conditions
- Acne Vulgaris
- Being tested
- CTX-4430, Placebo
- Keywords
- Facial Acne
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTX-4430Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | CTX-4430 oral capsule, 100 mg, once-daily for 12 weeks Receives: Drug: CTX-4430 |
| Placebo | Placebo comparator | Placebo: identical oral capsule, without active ingredient, once-daily for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy as measured by inflammatory lesion counts
Change from baseline in inflammatory lesion count after 12 weeks of treatment as compared to placebo.
Measured: 12 weeks
Safety as measured by the incidence of treatment emergent adverse events
Incidence of treatment emergent adverse events as compared to placebo.
Measured: 12 weeks
Secondary outcomes (2)
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.
Measured: 12 weeks
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionMay 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celtaxsys, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Network Services (CNS) Pty Ltd, Celtaxsys Aus Pty Limited
- Responsible party
- Sponsor
- Investigators
- Lynda J Spelman, MB BS, FACD, Principal investigator, Veracity Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02385760
- Sponsor's protocol ID
- CTX-4430-AV-201
- Status last verified
- Aug 2016
- First submitted
- 5 Mar 2015
- Last updated
- 2 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02385760
- Acronym / sponsor ID
- CTX-4430-AV-201
- Conditions
- Acne Vulgaris
- Keywords
- Facial Acne
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Celtaxsys, Inc.University, hospital or other
- Collaborators
- Clinical Network Services (CNS) Pty Ltd, Celtaxsys Aus Pty Limited
- Study start
- Apr 2015
- Primary completion
- May 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 11 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: CTX-4430CTX-4430 oral capsule, 100 mg, once-daily for 12 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo: identical oral capsule, without active ingredient, once-daily for 12 weeks |
Who may qualify
- Ages
- 16 to 44 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Must provide Informed consent.
- Male or female aged 16 to 44 inclusive.
- Moderate to severe facial acne vulgaris as defined in the protocol.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CTX-4430 | Drug | Active |
| Placebo | Drug | Placebo |
Primary outcome
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.
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.
2 secondary outcomes
Efficacy as measured by Investigator Global Assessment (IGA)
Time frame: 12 weeks
Efficacy as measured by non-inflammatory lesion counts
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lynda J Spelman, MB BS, FACD principal investigator
Veracity Clinical Research
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CTX-4430 in people with Acne Vulgaris, run by Celtaxsys, Inc. at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy as measured by inflammatory lesion counts (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2016.