Acne VulgarisPhase 2NCT02073461

Efficacy and Safety Study of 2 Different Concentrations of CD1579 Gels Versus Vehicle in the Treatment of Acne Vulgaris.

A Phase 2 study testing CD1579 2.5% and CD1579 5% in people with Acne Vulgaris, run by Galderma R&D at 6 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is to assess the efficacy and safety of two concentrations of CD1579 (2.5% and 5%) versus vehicle in the treatment of acne vulgaris in the Japanese patients. Read more about this study

Who is it for?: Ages 12 years and older
Conditions the study is for: Acne Vulgaris
What is being tested?: CD1579 2.5% and CD1579 5%
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 236 participants
Where: 6 sitesJapan
Study dates: Mar 2014to Oct 2014
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 12 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Men and women at the age of 12 or older at the Screening visit.
Those with clinical diagnosis of acne vulgaris with more than 20 noninflammatory lesions (open and closed comedones) and 12 to 100 (inclusive) inflammatory lesions (papules, pustules and nodules) on the face (forehead, both cheeks, nose and chin).

Who cannot join

Those with more than two nodular acne lesions or any cysts.
Those with the diagnosis of any acne conglobata, any acne fulminans, any chloracne, or any drug induced acne.
Those who have clinically significant abnormal findings or conditions on skin other than acne such as atopic dermatitis, perioral dermatitis, or rosacea that potentially interfere with study assessments according to Investigator's judgment

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

Japan6 sites

Galderma investigational site
Amagasaki, Hyōgo
Galderma investigational site
Fukuoka, Fukuoka
Galderma investigational site
Kobe, Hyōgo
Galderma investigational site
Nakano City, Tokyo
Galderma investigational site
Shibuya City, Tokyo
Galderma investigational site
Shinjuku, Tokyo

Other trials in Japan

About this study

Official title: A Multicenter, Randomized, Double-blinded, Vehicle-controlled Parallel Group Efficacy and Safety Study of 2 Different Concentrations of CD1579 Gels Versus Vehicle in the Treatment of Acne Vulgaris.

This study is to assess the efficacy and safety of two concentrations of CD1579 (2.5% and 5%) versus vehicle in the treatment of acne vulgaris in the Japanese patients.

Conditions: Acne Vulgaris
Being tested: CD1579 2.5%, CD1579 5%, Vehicle
Keywords: Acne Vulgaris
Medical subject headings: Acne Vulgaris

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CD1579 2.5%Drug
Also called Benzoyl Peroxide 2.5%
CD1579 5%Drug
Also called Benzoyl Peroxide 5%
VehicleDrug

Study groups in NCT02073461
Study group	Role	What they receive
CD1579 2.5%	Experimental	Benzoyl Peroxide 2.5% Receives: Drug: CD1579 2.5%
CD1579 5%	Experimental	Benzoyl Peroxide 5% Receives: Drug: CD1579 5%
Vehicle	Placebo comparator	Vehicle Receives: Drug: Vehicle

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Changes From Baseline in Total Lesion Counts
Median percent reductions from Baseline in total lesion count (ITT-LOCF)
Measured: Baseline - Week 12

Secondary outcomes (6)

Percent of Subjects With Adverse Events
Adverse events which were observed in 5% or more patients with either group are listed.
Measured: up to 12 weeks
Local Tolerability (Erythema)
Highest severity of local tolerability scores worse than Baseline
Measured: 12 weeks
Local Tolerability (Scaling)
Highest severity of local tolerability scores worse than Baseline
Measured: 12 weeks
Local Tolerability (Dryness)
Highest severity of local tolerability scores worse than Baseline
Measured: 12 weeks
Local Tolerability (Pruritus)
Highest severity of local tolerability scores worse than Baseline
Measured: 12 weeks
Local Tolerability (Stinging/Burning)
Highest severity of local tolerability scores worse than Baseline
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2014Oct 2014

First posted27 Feb 2014 (estimated)
Study startMar 2014
Primary completionOct 2014
Study completionOct 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Acne VulgarisStudies of the same condition, open and under way.
More trials run by Galderma R&DThe sponsor's other registered studies.
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: Double blind
Who is masked: Participant, Investigator
Enrolment: 236 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02073461
Sponsor's protocol ID: RDT.07.SPR.27124
Status last verified: Feb 2017
First submitted: 20 Feb 2014
Last updated: 28 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Acne Vulgaris trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-blinded, Vehicle-controlled Parallel Group Efficacy and Safety Study of 2 Different Concentrations of CD1579 Gels Versus Vehicle in the Treatment of Acne Vulgaris.
ClinicalTrials.gov ID: NCT02073461
Acronym / sponsor ID: RDT.07.SPR.27124
Conditions: Acne Vulgaris
Keywords: Acne Vulgaris
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 236 participants (actual)
Lead sponsor: Galderma R&DIndustry (pharma, biotech, devices)
Study start: Mar 2014
Primary completion: Oct 2014 (actual)
Study completion: Oct 2014 (actual)
First posted: 27 Feb 2014 (estimated)
Results: Posted 3 Nov 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study is to assess the efficacy and safety of two concentrations of CD1579 (2.5% and 5%) versus vehicle in the treatment of acne vulgaris in the Japanese patients.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
CD1579 2.5%	Experimental	Drug: CD1579 2.5%Benzoyl Peroxide 2.5%
CD1579 5%	Experimental	Drug: CD1579 5%Benzoyl Peroxide 5%
Vehicle	Placebo comparator	Drug: VehicleVehicle

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (2 listed)

Men and women at the age of 12 or older at the Screening visit.
Those with clinical diagnosis of acne vulgaris with more than 20 noninflammatory lesions (open and closed comedones) and 12 to 100 (inclusive) inflammatory lesions (papules, pustules and nodules) on the face (forehead, both cheeks, nose and chin).

Key exclusion criteria (3 listed)

Those with more than two nodular acne lesions or any cysts.
Those with the diagnosis of any acne conglobata, any acne fulminans, any chloracne, or any drug induced acne.
Those who have clinically significant abnormal findings or conditions on skin other than acne such as atopic dermatitis, perioral dermatitis, or rosacea that potentially interfere with study assessments according to Investigator's judgment

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
CD1579 2.5%Also: Benzoyl Peroxide 2.5%	Drug	CD1579 2.5%
CD1579 5%Also: Benzoyl Peroxide 5%	Drug	CD1579 5%
Vehicle	Drug	Vehicle

Primary outcome

Percent Changes From Baseline in Total Lesion Counts
Time frame: Baseline - Week 12
Median percent reductions from Baseline in total lesion count (ITT-LOCF)

6 secondary outcomes

Percent of Subjects With Adverse Events
Time frame: up to 12 weeks
Local Tolerability (Erythema)
Time frame: 12 weeks
Local Tolerability (Scaling)
Time frame: 12 weeks
Local Tolerability (Dryness)
Time frame: 12 weeks
Local Tolerability (Pruritus)
Time frame: 12 weeks
Local Tolerability (Stinging/Burning)
Time frame: 12 weeks

Results and safety

Results posted to the registry on 3 Nov 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CD1579 2.5%	79	75
CD1579 5%	78	77
Vehicle	79	78

Primary outcome: Percent Changes From Baseline in Total Lesion Counts

Time frame: Baseline - Week 12. Median (Full Range). Unit: percent change

Measure	CD1579 2.5% n = 79	CD1579 5% n = 78	Vehicle n = 78
Value	58.3 (-243.7 to 100)	65.9 (-41.0 to 100)	25.5 (-180.7 to 88.9)

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 weeks. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CD1579 2.5%	0 of 79 (0%)	34 of 79 (43%)	Not reported
CD1579 5%	0 of 78 (0%)	31 of 78 (39.7%)	Not reported
Vehicle	1 of 79 (1.3%)	26 of 79 (32.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

The record lists no contact. Use the official record to reach the sponsor.

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CD1579 2.5% and CD1579 5% in people with Acne Vulgaris, run by Galderma R&D at 6 sites in Japan.

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 2 inclusion and 3 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 28 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Japan. 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?

Yes. Results are posted in the registry (first posted 3 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percent Changes From Baseline in Total Lesion Counts (time frame: Baseline - Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02073461.

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 28 Mar 2017.