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Acne VulgarisPhase 3NCT02566369

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 124 sites in 5 countries.

Completed

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

Official record
Search all trials

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
1,208 participants
Where
124 sitesin 5 countries
Study dates
30 Nov 2015to 14 Nov 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

124 sites in 5 countries.

124 sites in 5 countries

United States86 sites

  • Galderma Investigational Site (# 8542)

    Arlington, Texas, 76017

  • Galderma Investigational Site (# 8367)

    Arlington Heights, Illinois, 60005

  • Galderma Investigational Site (#8513)

    Austin, Texas, 78705

  • Galderma Investigational Site (#8512)

    Bay City, Michigan, 48706

  • Galderma Investigational Site (# 8195)

    Beachwood, Ohio, 44122

  • Galderma Investigational site (8579)

    Beaumont, Texas, 77701

  • Galderma Investigational Site (# 8456)

    Beverly Hills, California, 90212

  • Galderma Investigational Site (# 8370)

    Boynton Beach, Florida, 33437

  • Galderma Investigational Site (#8500)

    Brooklyn, New York, 11203

  • Galderma Investigational site (8578)

    Cerritos, California, 90703

  • Galderma Investigational Site (# 8369)

    Charleston, South Carolina, 29414

  • Galderma Investigational Site (8566)

    Charlotte, North Carolina, 28277

  • Galderma Investigational Site (8191)

    Chicago, Illinois, 60611

  • Galderma Investigational Site (# 8016)

    Cincinnati, Ohio, 45255

  • Galderma Investigational Site (8574)

    Clarkston, Michigan, 48346

  • Galderma Investigational Site (#8033)

    Clinton Township, Michigan, 48038

  • Galderma Investigational Site (# 8526)

    Clovis, California, 93612

  • Galderma Investigational Site (8572)

    Colorado Springs, Colorado, 80920

  • Galderma Investigational Site (# 8245)

    Dallas, Texas, 75231

  • Galderma Investigational site (8571)

    Darien, Illinois, 60561

  • Galderma Investigational site (8595)

    Dublin, Ohio, 43016

  • Galderma Investigational Site (8524)

    East Setauket, New York, 11733

  • Galderma Investigational Site (8577)

    Encinitas, California, 92024

  • Galderma Investigational Site (# 8510)

    Englewood, Colorado, 80113

  • Galderma Investigational Site (8129)

    Fort Gratiot, Michigan, 48059

  • Galderma Investigational Site (# 8543)

    Fort Lauderdale, Florida, 33316

  • Galderma Investigational Site (# 8224)

    Fremont, California, 94538

  • Galderma Investigational Site (# 8509)

    Fullerton, California, 92835

  • Galderma Investigational Site (# 8530)

    Glendale, Arizona, 85308

  • Galderma Investigational Site (# 8012)

    Glenn Dale, Maryland, 20769

  • Galderma Investigational Site (# 8506)

    Hackensack, New Jersey, 07601

  • Galderma Investigational Site (8188)

    Hershey, Pennsylvania, 17033

  • Galderma Investigational Site (#8514)

    Hickory, North Carolina, 28602

  • Galderma Investigational Site (# 8009)

    Hot Springs, Arkansas, 71913

  • Galderma Investigational Site (8183)

    Houston, Texas, 77030

  • Galderma Investigational Site (# 8507)

    Huntington Beach, California, 92647

  • Galderma Investigational Site (8582)

    Idaho Falls, Idaho, 83404

  • Galderma Investigational site (8576)

    Katy, Texas, 77949

  • Galderma Investigational Site (# 8117)

    Knoxville, Tennessee, 37917

  • Galderma Investigational Site (# 8108)

    Las Vegas, Nevada, 89144

  • Galderma Investigational site (8106)

    Layton, Utah, 84041

  • Galderma Investigational Site (# 8544)

    Lincoln, Nebraska, 68502

  • Galderma Investigational Site (# 8069)

    Louisville, Kentucky, 40202

  • Galderma Investigational Site (8092)

    Louisville, Kentucky, 40217

  • Galderma Investigational Site (8143)

    Miami, Florida, 33175

  • Galderma Investigational site (8259)

    Miramar, Florida, 33027

  • Galderma Investigational Site (8258)

    Mobile, Alabama, 36608

  • Galderma Investigational Site (8457)

    Monroe, Louisiana, 71203

  • Galderma Investigational Site (8583)

    Murphy, Texas, 75094

  • Galderma Investigational Site (# 8515)

    Nashville, Tennessee, 37203

  • Galderma Investigational site (8580)

    New Orleans, Louisiana, 70130

  • Galderma Investigational Site (8568)

    New York, New York, 10022

  • Galderma Investigational Site (8585)

    New York, New York, 10028

  • Galderma Investigational Site (8279)

    New York, New York, 10075

  • Galderma Investigational Site (#8420)

    Newington, New Hampshire, 03801

  • Galderma Investigational Site (# 8425)

    Newport Beach, California, 92663

  • Galderma Investigational Site (# 8522)

    North Miami Beach, Florida, 33162

  • Galderma Investigational Site (8575)

    Oakbrook Terrace, Illinois, 60180

  • Galderma Investigational Site (# 8052)

    Oceanside, California, 92056

  • Galderma Investigational Site (# 8531)

    Orange Park, Florida, 32073

  • Galderma Investigational Site (8502)

    Orlando, Florida, 32814

  • Galderma Investigational Site (#8213)

    Ormond Beach, Florida, 32174

  • Galderma Investigational Site (# 8532)

    Overland Park, Kansas, 66215

  • Galderma Investigational Site (8545)

    Owensboro, Kentucky, 42301

  • Galderma Investigational Site (# 8511)

    Phoenix, Arizona, 85018

  • Galderma Investigational Site (# 8366)

    Plainfield, Indiana, 46168

  • Galderma Investigational Site (# 8541)

    Quincy, Massachusetts, 02169

  • Galderma Investigational Site (# 8525)

    Rockville, Maryland, 20850

  • Galderma Investigational Site (# 8355)

    Rogers, Arkansas, 72758

  • Galderma Investigational Site (# 8521)

    Saint Joseph, Missouri, 64506

  • Galderma Investigational Site (# 8214)

    Salt Lake City, Utah, 84117

  • Galderma Investigational Site (8567)

    San Antonio, Texas, 78213

  • Galderma Investigational site (8433)

    San Antonio, Texas, 78218

  • Galderma Investigational site (8329)

    San Antonio, Texas, 78229

  • Galderma Investigational Site (# 8529)

    Sanford, Florida, 32771

  • Galderma Investigational Site (# 8528)

    Santa Ana, California, 92701

  • Galderma Investigational Site (# 8160)

    Santa Monica, California, 91301

  • Galderma Investigational Site (# 8351)

    Seattle, Washington, 98104

  • Galderma Investigational Site (#8189)

    Snellville, Georgia, 30078

  • Galderma Investigational Site (#8027)

    St Louis, Missouri, 63141

  • Galderma Investigational Site (# 8455)

    St. Petersburg, Florida, 33708

  • Galderma Investigational Site (# 8523)

    Tampa, Florida, 33609

  • Galderma Investigational Site (# 8443)

    Temecula, California, 92592

  • Galderma Investigational Site (# 8226)

    Warren, Michigan, 48088

  • Galderma Investigational Site (# 8126)

    West Palm Beach, Florida, 33401

  • Galderma Investigational site (8353)

    Yardley, Pennsylvania, 19067

Other trials in United States

Canada13 sites

  • Galderma Investigational Site (8586)

    Barrie, Ontario, L4M 7G1

  • Galderma Investigational Site (# 8215)

    Calgary, Alberta, T3A 2N1

  • Galderma Investigational Site (# 8038)

    Hamilton, Ontario, L8N 1V6

  • Galderma Investigational Site (# 8426)

    London, Ontario, N5X 2P1

  • Galderma Investigational Site (# 8026)

    Markham, Ontario, L3P 1X2

  • Galderma Investigational Site (# 8135)

    North Bay, Ontario, P1B 3Z7

  • Galderma Investigational Site (# 8168)

    Oakville, Ontario, L6J 7W5

  • Galderma Investigational Site (# 8340)

    Peterborough, Ontario, K9J 5K2

  • Galderma Investigational Site (# 8338)

    Richmond Hill, Ontario, L4B 1A5

  • Galderma Investigational site (8161)

    Surrey, British Columbia, V3V 0C6

  • Galderma Investigational Site (8001)

    Waterloo, Ontario, N2J 1C4

  • Galderma Investigational Site (# 8060)

    Windsor, Ontario, N8W 5L7

  • Galderma Investigational Site (# 8154)

    Winnipeg, Manitoba, R3C 0N2

Other trials in Canada

Germany12 sites

  • Galderma Investigational Site (5566)

    Augsburg, 86179

  • Galderma Investigational Site (5604)

    Berlin, 10117

  • Galderma Investigational Site (5815)

    Berlin, 13507

  • Galderma Investigational Site (5750)

    Darmstadt, 64283

  • Galderma Investigational Site (5572)

    Dessau, 6847

  • Galderma Investigational Site (5204)

    Dresden, 1097

  • Galderma Investigational Site (5434)

    Dresden, 1307

  • Galderma Investigational Site (5146)

    Eberstadt, 64297

  • Galderma Investigational Site (5838)

    Hamburg, 20354

  • Galderma Investigational Site (5635)

    Langenau, 89129

  • Galderma Investigational Site (5543)

    Mainz, 55131

  • Galderma Investigational Site (5307)

    Münster, 48149

Other trials in Germany

Hungary9 sites

  • Galderma Investigational Site (5802)

    Balatonfüred, 08230

  • Galderma Investigational Site (5567)

    Budapest, 01036

  • Galderma Investigational Site (5812)

    Budapest, 01125

  • Galderma Investigational Site (5685)

    Cegléd, 02700

  • Galderma Investigational Site (5254)

    Nyíregyháza, 4400

  • Galderma Investigational Site (5811)

    Pécel, 02119

  • Galderma Investigational Site (5263)

    Püspökladány, 4150

  • Galderma Investigational Site (5237)

    Szeged, 6720

  • Galderma Investigational Site (5767)

    Szekszàrd, 07100

Other trials in Hungary

Puerto Rico4 sites

  • Galderma Investigational Site (8592)

    Aibonito, 705

  • Galderma Investigational Site (8594)

    Caguas, 727

  • Galderma Investigational site (8100)

    Carolina, 985

  • Galderma Investigational Site (8593)

    San Juan, 00909-3004

Other trials in Puerto Rico

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.

Read the detailed description

Clinical Trial for each subject is approximately 14 weeks and are randomized to one of the two treatments for 12 weeks. Subjects must be 9 years of age and older 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 for 12 weeks.

  • Placebo creamDrug

    Placebo cream applied once daily for 12 weeks

Study groups in NCT02566369
Study groupRoleWhat they receive
CD5789 (trifarotene) 50μg/g CreamExperimentalCD5789 (trifarotene) 50μg/g Cream
Receives: Drug: CD5789 (trifarotene) 50μg/g cream
Placebo CreamPlacebo comparatorPlacebo cream
Receives: Drug: Placebo cream

What is being measured

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

  1. Investigator Global Assessment (IGA) Success Rate at 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.

    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.

  1. First posted2 Oct 2015 (estimated)
  2. Study start30 Nov 2015
  3. Primary completion14 Nov 2017
  4. Study completion14 Nov 2017

Resources

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
1,208 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02566369
Sponsor's protocol ID
RD.06.SPR.18251
Status last verified
Jul 2018
First submitted
1 Oct 2015
Last updated
12 Nov 2019
Data monitoring committee
No
Individual data sharing
No

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 124 sites in 5 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 124 sites in United States, Canada, Germany, Hungary, Puerto Rico. 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 22 Aug 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 at Week 12 (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?

On the ClinicalTrials.gov record for NCT02566369.

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.

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