Acne VulgarisPhase 3NCT02189629

CD5789 (Trifarotene) Long Term Safety Study on Acne Vulgaris

A Phase 3 study testing CD5789 (trifarotene) in people with Acne Vulgaris, run by Galderma R&D at 32 sites in 4 countries.

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

Multi-center, open-label, non-comparative safety and efficacy study with 52 Weeks of treatment on the face and trunk for acne vulgaris. Read more about this study

Who is it for?: Ages 9 years and older
Conditions the study is for: Acne Vulgaris
What is being tested?: CD5789 (trifarotene)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 453 participants
Where: 32 sitesin 4 countries
Study dates: 23 Feb 2015to 23 Feb 2017
Phase: Phase 3
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 9 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

The Subject has a facial acne severity grade of IGA grade 3 (moderate) at Screening and Baseline visits.
The Subject has a minimum of 20 inflammatory lesions and 25 non-inflammatory lesions at Screening and Baseline visits on the face.

Who cannot join

The subject has severe forms of acne (acne conglobata, acne fulminans) or secondary acne form (chloracne, drug-induced acne, etc.).
The Subject has more than 1 nodule on the face at Screening and at Baseline visits.
The Subject has any acne cyst on the face at Screening and at Baseline visits.

Trial locations and contacts

32 sites in 4 countries.

Country

City, postcode or hospital

32 sites in 4 countries

United States14 sites

Galderma Investigational Site
Albuquerque, New Mexico, 87107
Galderma Investigational Site
Beachwood, Ohio, 44122
Galderma Investigational Site
High Point, North Carolina, 27262
Galderma Investigational Site
Knoxville, Tennessee, 37922
Galderma Investigational Site
Louisville, Kentucky, 40241
Galderma Investigational Site
Miami, Florida, 33175
Galderma Investigational Site
Miramar, Florida, 33027
Galderma Investigational Site
Mobile, Alabama, 36608
Galderma Investigational Site
New York, New York, 10155
Galderma Investigational Site
Newnan, Georgia, 30277
Galderma Investigational Site
Portland, Oregon, 97210
Galderma Investigational Site
Rogers, Arkansas, 72758
Galderma Investigational Site
Sacramento, California, 95819
Galderma Investigational Site
San Diego, California, 92123

Other trials in United States

Germany7 sites

Galderma Investigational Site
Augsburg, 86179
Galderma Investigational Site
Berlin, 10117
Galderma Investigational Site
Berlin, 13507
Galderma Investigational Site
Dessau, 06847
Galderma Investigational Site
Mahlow, 15831
Galderma Investigational Site
Münster, 48149
Galderma Investigational Site
Wuppertal, 42287

Other trials in Germany

Hungary6 sites

Galderma Investigational Site
Balatonfüred, 8230
Galderma Investigational Site
Miskolc, 3529
Galderma Investigational Site
Pécel, 2119
Galderma Investigational Site
Szeged, 6720
Galderma Investigational Site
Szekszárd, 7100
Galderma Investigational Site
Szolnok, 5000

Other trials in Hungary

Czechia5 sites

Galderma Investigational Site
Chomutov, 430 04
Galderma Investigational site
Hradec Králové, 500 05
Galderma Investigational Site
Olomouc, 775 20
Galderma Investigational Site
Pardubice, 532 03
Galderma Investigational site
Prague, 110 00

Other trials in Czechia

About this study

Official title: A LONG-TERM SAFETY AND EFFICACY STUDY OF CD5789 (Trifarotene) 50 µg/g CREAM IN SUBJECTS WITH ACNE VULGARIS

Multi-center, open-label, non-comparative safety and efficacy study with 52 Weeks of treatment on the face and trunk for acne vulgaris.

Read the detailed description

To determine the safety and efficacy of CD5789 (trifarotene) 50 µg/g cream in the long-term treatment (up to 52 Weeks) of subjects with acne vulgaris. Efficacy will be evaluated as a secondary objective.

Conditions: Acne Vulgaris
Being tested: CD5789 (trifarotene)
Keywords: Acne vulgaris, Safety, Face, Trunk
Medical subject headings: Acne Vulgaris, Facies

What participants receive

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

CD5789 (trifarotene)Drug

Study groups in NCT02189629
Study group	Role	What they receive
CD5789 (trifarotene) cream	Experimental	Not described Receives: Drug: CD5789 (trifarotene)

What is being measured

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

Investigator Global Assessment (IGA) Success Rate up to Week 52
Number of subjects who achieved an Investigator Global Assessment (IGA) score of 1 (almost clear) or 0 (clear).
Measured: From Baseline to Week 52

Secondary outcomes (1)

Physician Global Assessment (PGA) Success Rate up to Week 52
Number of subjects who achieved a Physician Global Assessment (PGA) score of 1 (almost clear) or 0 (clear).
Measured: From Baseline to Week 52

Timeline

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

23 Feb 201523 Feb 2017

First posted14 Jul 2014 (estimated)
Study start23 Feb 2015
Primary completion23 Feb 2017
Study completion23 Feb 2017

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 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 453 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02189629
Sponsor's protocol ID: RD.06.SPR.18250
Status last verified: Nov 2019
First submitted: 11 Jul 2014
Last updated: 14 Nov 2019
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

Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
Acne, Acne Papulopustulosa
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
Acne Vulgaris
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
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All Acne Vulgaris trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A LONG-TERM SAFETY AND EFFICACY STUDY OF CD5789 (Trifarotene) 50 µg/g CREAM IN SUBJECTS WITH ACNE VULGARIS
ClinicalTrials.gov ID: NCT02189629
Acronym / sponsor ID: RD.06.SPR.18250
Conditions: Acne Vulgaris
Keywords: Acne vulgaris, Safety, Face, Trunk
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 453 participants (actual)
Lead sponsor: Galderma R&DIndustry (pharma, biotech, devices)
Study start: 23 Feb 2015 (actual)
Primary completion: 23 Feb 2017 (actual)
Study completion: 23 Feb 2017 (actual)
First posted: 14 Jul 2014 (estimated)
Results: Posted 17 Sep 2019

Clinical summary

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

Multi-center, open-label, non-comparative safety and efficacy study with 52 Weeks of treatment on the face and trunk for acne vulgaris.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
CD5789 (trifarotene) cream	Experimental	Drug: CD5789 (trifarotene)

Who may qualify

Ages: 9 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (2 listed)

The Subject has a facial acne severity grade of IGA grade 3 (moderate) at Screening and Baseline visits.
The Subject has a minimum of 20 inflammatory lesions and 25 non-inflammatory lesions at Screening and Baseline visits on the face.

Key exclusion criteria (3 listed)

The subject has severe forms of acne (acne conglobata, acne fulminans) or secondary acne form (chloracne, drug-induced acne, etc.).
The Subject has more than 1 nodule on the face at Screening and at Baseline visits.
The Subject has any acne cyst on the face at Screening and at Baseline visits.

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
CD5789 (trifarotene)	Drug	CD5789 (trifarotene) cream

Primary outcome

Investigator Global Assessment (IGA) Success Rate up to Week 52
Time frame: From Baseline to Week 52
Number of subjects who achieved an Investigator Global Assessment (IGA) score of 1 (almost clear) or 0 (clear).

1 secondary outcome

Physician Global Assessment (PGA) Success Rate up to Week 52
Time frame: From Baseline to Week 52

Results and safety

Results posted to the registry on 17 Sep 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CD5789 Cream	453	348

Primary outcome: Investigator Global Assessment (IGA) Success Rate up to Week 52

Time frame: From Baseline to Week 52. Count of participants. Unit: Participants

Measure	CD5789 Cream n = 453
Value	453

Population analysed: A total of 455 subjects were enrolled in the study, of whom 453 were treated with CD5789 50 microgram/gram.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Over 52 Weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CD5789 Cream	10 of 453 (2.2%)	170 of 453 (37.5%)	0 of 453

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Acne Vulgaris

Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
Acne, Acne Papulopustulosa
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
Acne Vulgaris
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal

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.

Kevin Chan study director

Galderma R&D

32 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CD5789 (trifarotene) in people with Acne Vulgaris, run by Galderma R&D at 32 sites in 4 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 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 14 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in United States, Germany, Hungary, Czechia. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 17 Sep 2019). 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?

Investigator Global Assessment (IGA) Success Rate up to Week 52 (time frame: From Baseline to Week 52). 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 NCT02189629.

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 14 Nov 2019.