Acne VulgarisPhase 3NCT02556788
Double-Blind Efficacy and Safety of CD5789 (Trifarotene) 50µg/g Cream Versus Vehicle Cream in Acne Vulgaris
A Phase 3 study testing CD5789 (trifarotene) 50µg/g Cream in people with Acne Vulgaris, run by Galderma R&D at 81 sites in 8 countries.
Trial summary
Assessment of the efficacy and safety of CD5789 (Trifarotene) 50µg/g cream applied once daily for 12 weeks in subjects with 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) 50µg/g Cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,212 participants
- Where
- 81 sitesin 8 countries
- Study dates
- Nov 2015to 12 May 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 is a male or female, 9 years of age or older, at Screening visit.
- The Subject has moderate acne at Screening and Baseline.
- The subject is a female of non childbearing potential
- The subject is a female of childbearing potential with a negative pregnancy test and who is strictly abstinent or who agrees to use an effective and approved contraceptive method for the duration of the study and at least 1 month after the last study drug application.
Who cannot join
- The subject has severe forms of acne (e.g., acne conglobate, acne fulminant) or secondary acne form (e.g.,chloracne, drug-induced acne, etc.).
- The subject has any uncontrolled or serious disease or any medical or surgical condition that may either interfere with the interpretation of the trial results and/or put the subject at significant risk (according to the Investigator's judgment) if the subject takes part to the trial.
- The subject has been exposed to excessive ultraviolet (UV) radiation within one month prior to the Baseline visit or the subject is planning intense UV exposure during the study (i.e., occupational exposure to the sun, sunbathing, tanning salon use, phototherapy, etc.)
- The subject is unwilling to refrain from use of prohibited medication during the clinical trial
Trial locations and contacts
81 sites in 8 countries.
81 sites in 8 countries
United States29 sites
Galderma Investigational Site
Ann Arbor, Michigan, 48103
Galderma Invetsigational site
Austin, Texas, 78759-8858
Galderma Investigational Site
Aventura, Florida, 33180
Galderma Investigational Site
Beverly, Massachusetts, 01915
Galderma Investigational Site
Birmingham, Alabama, 35205
Galderma Investigational Site
Brooklyn, New York, 11203
Galderma Investigational Site
Corbin, Kentucky, 40701
Galderma Investigational Site
Dallas, Texas, 75230-5806
Galderma Investigational Site
Detroit, Michigan, 48202
Galderma Investigational Site
Fort Smith, Arkansas, 72916
Galderma Investigational Site
Fort Washington, Pennsylvania, 19034
Galderma Investigational Site
Goodlettsville, Tennessee, 37072
Galderma Investigational Site
Greer, South Carolina, 29650
Galderma Investigational Site
Houston, Texas, 77004
Galderma Investigational Site
Los Angeles, California, 90036
Galderma Investigational Site
Miami, Florida, 33144
Galderma Investigational Site
Miami Lakes, Florida, 33016
Galderma Investigational Site
Murrieta, California, 92562
Galderma Investigational Site
Pflugerville, Texas, 78660
Galderma Investigational Site
Philadelphia, Pennsylvania, 19103
Galderma Investigational Site
Phoenix, Arizona, 85032
Galderma Investigational Site
San Antonio, Texas, 78249
Galderma Investigational Site
Santa Ana, California, 92705
Galderma Investigational Site
Stony Brook, New York, 11790
Galderma Investigational Site
Tucson, Arizona, 85712
Galderma Investigational Site
Walla Walla, Washington, 99362
Galderma Investigational Site
Webster, Texas, 77598
Galderma Investigational Site
West Palm Beach, Florida, 33406
Galderma Investigational Site
Wilmington, North Carolina, 28401
Poland14 sites
Galderma Investigational Site
Bialystok, 15-453
Galderma Investigational Site
Gdansk, 80-152
Galderma Investigational Site
Gdansk, 80-402
Galderma Investigational Site
Gdansk, 80-546
Galderma Investigational Site
Katowice, 40-036
Galderma investigational Site
Katowice, 40-611
Galderma Investigational Site
Katowice, 40-851
Galderma Investigational Site
Lodz, 90-242
Galderma Investigational Site
Sochaczew, 95-500
Galderma Investigational Site
Warsaw, 01-817
Galderma investigational Site
Warsaw, 02-657
Galderma Investigational Site
Warsaw, 02-758
Galderma Investigational Site
Wroclaw, 51-318
Galderma Investigational Site
Wroclaw, 53-658
Czechia8 sites
Galderma Investigational Site
Chomutov, 430 04
Galderma Investigational Site
Hradec Králové, 500 05
Galderma Investigational Site
Kutná Hora, 284 01
Galderma Investigational Site
Olomouc, 775 20
Galderma Investigational Site
Pardubice, 532 03
Galderma Investigational Site
Prague, 11 000
Galderma Investigational Site
Prague, 110 00
Galderma Investigational Site
Prague, 190 11
Ukraine8 sites
Galderma Investigational Site
Dnipropetrovsk, 49044
Galderma Investigational Site
Dnipropetrovsk, 49074
Galderma Investigational Site
Ivano-Frankivsk, 76000
Galderma Investigational Site
Kharkiv, 61057
Galderma Investigational Site
Kyiv, 01601
Galderma Investigational Site
Kyiv, 04209
Galderma Investigational Site
Lviv, 79049
Galderma Investigational Site
Uzhhorod, 88000
Hungary7 sites
Galderma Investigational Site
Budapest, 1035
Galderma Investigational Site
Budapest, 1089
Galderma Investigational Site
Debrecen, 4032
Galderma Investigational Site
Miskolc, 3529
Galderma Investigational Site
Pécs, 7632
Galderma Investigational Site
Szeged, 6720
Galderma Investigational Site
Szolnok, 5000
Russia7 sites
Galderma Investigational Site
Krasnodar, 3500 20
Galderma Investigational Site
Lipetsk, 398035
Galderma Investigational Site
Moscow, 107076
Galderma Investigational Site
Moscow, 119071
Galderma Investigational Site
Moscow, 121614
Galderma Investigational Site
Saint Petersburg, 194100
Galderma Investigational Site
Sr Petersburg, 194021
Romania4 sites
Galderma Investigational Site
Brasov, 500283
Galderma Investigational Site
Craiova, 200642
Galderma Investigational Site
Iași, 700381
Galderma Investigational Site
Târgu Mureş, 540530
Spain4 sites
Galderma Investigational Site
Barcelona, 08206
Galderma Investigational Site
Esplugues de Llobregat, 8950
Galderma Investigational site
Madrid, 28009
Galderma Investigational Site
Valencia, 46014
About this study
Official title: A Multi-Center, Randomized, Double-Blind, Parallel-Group Vehicle Controlled Study To Compare The Efficacy And Safety Of CD5789 (Trifarotene) 50µg/g Cream Versus Vehicle Cream In Subjects With Acne Vulgaris
Assessment of the efficacy and safety of CD5789 (Trifarotene) 50µg/g cream applied once daily for 12 weeks in subjects with acne vulgaris.
- Conditions
- Acne Vulgaris
- Being tested
- CD5789 (trifarotene) 50µg/g Cream, Placebo Cream
- Keywords
- Efficacy, Safety, 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.
CD5789 (trifarotene) 50µg/g CreamDrug
CD5789 (Trifarotene) 50µg/g cream applied once daily during 12 weeks.
Placebo CreamDrug
Placebo cream applied once daily during 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| CD5789 (Trifarotene) 50µg/g Cream | Experimental | CD5789 (trifarotene) 50µg/g Cream Receives: Drug: CD5789 (trifarotene) 50µg/g Cream |
| Placebo Cream | Placebo comparator | Placebo Cream Receives: Drug: Placebo Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator Global Assessment (IGA) Score of 1 (Almost Clear) or 0 (Clear)
Number of subjects who achieved an Investigator Global Assessment (IGA) score of 1 (almost clear) or 0 (Clear) and at least a 2-grade improvement from Baseline to Week 12.
Measured: From Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2015 (estimated)
- Study startNov 2015
- Primary completion7 Feb 2017
- Study completion12 May 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,212 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kevin Chan, Study director, Galderma R&D
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02556788
- Sponsor's protocol ID
- RD.06.SPR.18252
- Status last verified
- Jul 2018
- First submitted
- 18 Sep 2015
- Last updated
- 12 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Double-Blind, Parallel-Group Vehicle Controlled Study To Compare The Efficacy And Safety Of CD5789 (Trifarotene) 50µg/g Cream Versus Vehicle Cream In Subjects With Acne Vulgaris
- ClinicalTrials.gov ID
- NCT02556788
- Acronym / sponsor ID
- RD.06.SPR.18252
- Conditions
- Acne Vulgaris
- Keywords
- Efficacy, Safety, Acne vulgaris
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,212 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- 7 Feb 2017 (actual)
- Study completion
- 12 May 2017 (actual)
- First posted
- 22 Sep 2015 (estimated)
- Results
- Posted 3 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assessment of the efficacy and safety of CD5789 (Trifarotene) 50µg/g cream applied once daily for 12 weeks in subjects with acne vulgaris.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CD5789 (Trifarotene) 50µg/g Cream | Experimental | Drug: CD5789 (trifarotene) 50µg/g CreamCD5789 (trifarotene) 50µg/g Cream |
| Placebo Cream | Placebo comparator | Drug: Placebo CreamPlacebo Cream |
Who may qualify
- Ages
- 9 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- The subject is a male or female, 9 years of age or older, at Screening visit.
- The Subject has moderate acne at Screening and Baseline.
- The subject is a female of non childbearing potential
- The subject is a female of childbearing potential with a negative pregnancy test and who is strictly abstinent or who agrees to use an effective and approved contraceptive method for the duration of the study and at least 1 month after the last study drug application.
Key exclusion criteria (4 listed)
- The subject has severe forms of acne (e.g., acne conglobate, acne fulminant) or secondary acne form (e.g.,chloracne, drug-induced acne, etc.).
- The subject has any uncontrolled or serious disease or any medical or surgical condition that may either interfere with the interpretation of the trial results and/or put the subject at significant risk (according to the Investigator's judgment) if the subject takes part to the trial.
- The subject has been exposed to excessive ultraviolet (UV) radiation within one month prior to the Baseline visit or the subject is planning intense UV exposure during the study (i.e., occupational exposure to the sun, sunbathing, tanning salon use, phototherapy, etc.)
- The subject is unwilling to refrain from use of prohibited medication during the clinical trial
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) 50µg/g CreamCD5789 (Trifarotene) 50µg/g cream applied once daily during 12 weeks. | Drug | CD5789 (Trifarotene) 50µg/g Cream |
| Placebo CreamPlacebo cream applied once daily during 12 weeks. | Drug | Placebo Cream |
Primary outcome
Investigator Global Assessment (IGA) Score of 1 (Almost Clear) or 0 (Clear)
Time frame: From Baseline to Week 12
Number of subjects who achieved an Investigator Global Assessment (IGA) score of 1 (almost clear) or 0 (Clear) and at least a 2-grade improvement from Baseline to Week 12.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2019.
- 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.
Kevin Chan study director
Galderma R&D
81 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CD5789 (trifarotene) 50µg/g Cream in people with Acne Vulgaris, run by Galderma R&D at 81 sites in 8 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 4 inclusion and 4 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 12 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 81 sites in United States, Poland, Czechia, Ukraine, Hungary and 3 more countries. 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 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 3 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) Score of 1 (Almost Clear) or 0 (Clear) (time frame: From Baseline to Week 12). 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 12 Nov 2019.