Efficacy and Safety of CD5789 (Trifarotene) 50μg/g Cream Versus Vehicle Cream in Acne Vulgaris

NCT02566369 | Completed Phase 3 Results

• 1 other identifier: RD.06.SPR.18251
• Study Type: interventional
• Target: 1,208
• Locations: 5 countries
• Sites: 124

Brief Summary

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

Keywords

Efficacy; Safety; Acne vulgaris

Outcome Measures

Primary Outcomes (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.

  From Baseline to Week 12

Study Arms (2)

CD5789 (trifarotene) 50μg/g Cream

EXPERIMENTAL

CD5789 (trifarotene) 50μg/g Cream

Drug: CD5789 (trifarotene) 50μg/g cream

Placebo Cream

PLACEBO COMPARATOR

Placebo cream

Drug: Placebo cream

Interventions

CD5789 (trifarotene) 50μg/g cream DRUG

CD5789 (trifarotene) 50µg/g cream applied once daily for 12 weeks.

CD5789 (trifarotene) 50μg/g Cream

Placebo cream DRUG

Placebo cream applied once daily for 12 weeks

Placebo Cream

Eligibility Criteria

• Age: 9 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (124)

Galderma Investigational Site (8258)

Mobile, Alabama, 36608, United States

Location

Galderma Investigational Site (# 8530)

Glendale, Arizona, 85308, United States

Location

Galderma Investigational Site (# 8511)

Phoenix, Arizona, 85018, United States

Location

Galderma Investigational Site (# 8009)

Hot Springs, Arkansas, 71913, United States

Location

Galderma Investigational Site (# 8355)

Rogers, Arkansas, 72758, United States

Location

Galderma Investigational Site (# 8456)

Beverly Hills, California, 90212, United States

Location

Galderma Investigational site (8578)

Cerritos, California, 90703, United States

Location

Galderma Investigational Site (# 8526)

Clovis, California, 93612, United States

Location

Galderma Investigational Site (8577)

Encinitas, California, 92024, United States

Location

Galderma Investigational Site (# 8224)

Fremont, California, 94538, United States

Location

Galderma Investigational Site (# 8509)

Fullerton, California, 92835, United States

Location

Galderma Investigational Site (# 8507)

Huntington Beach, California, 92647, United States

Location

Galderma Investigational Site (# 8425)

Newport Beach, California, 92663, United States

Location

Galderma Investigational Site (# 8052)

Oceanside, California, 92056, United States

Location

Galderma Investigational Site (# 8528)

Santa Ana, California, 92701, United States

Location

Galderma Investigational Site (# 8160)

Santa Monica, California, 91301, United States

Location

Galderma Investigational Site (# 8443)

Temecula, California, 92592, United States

Location

Galderma Investigational Site (8572)

Colorado Springs, Colorado, 80920, United States

Location

Galderma Investigational Site (# 8510)

Englewood, Colorado, 80113, United States

Location

Galderma Investigational Site (# 8370)

Boynton Beach, Florida, 33437, United States

Location

Galderma Investigational Site (# 8543)

Fort Lauderdale, Florida, 33316, United States

Location

Galderma Investigational Site (8143)

Miami, Florida, 33175, United States

Location

Galderma Investigational site (8259)

Miramar, Florida, 33027, United States

Location

Galderma Investigational Site (# 8522)

North Miami Beach, Florida, 33162, United States

Location

Galderma Investigational Site (# 8531)

Orange Park, Florida, 32073, United States

Location

Galderma Investigational Site (8502)

Orlando, Florida, 32814, United States

Location

Galderma Investigational Site (#8213)

Ormond Beach, Florida, 32174, United States

Location

Galderma Investigational Site (# 8529)

Sanford, Florida, 32771, United States

Location

Galderma Investigational Site (# 8455)

St. Petersburg, Florida, 33708, United States

Location

Galderma Investigational Site (# 8523)

Tampa, Florida, 33609, United States

Location

Galderma Investigational Site (# 8126)

West Palm Beach, Florida, 33401, United States

Location

Galderma Investigational Site (#8189)

Snellville, Georgia, 30078, United States

Location

Galderma Investigational Site (8582)

Idaho Falls, Idaho, 83404, United States

Location

Galderma Investigational Site (# 8367)

Arlington Heights, Illinois, 60005, United States

Location

Galderma Investigational Site (8191)

Chicago, Illinois, 60611, United States

Location

Galderma Investigational site (8571)

Darien, Illinois, 60561, United States

Location

Galderma Investigational Site (8575)

Oakbrook Terrace, Illinois, 60180, United States

Location

Galderma Investigational Site (# 8366)

Plainfield, Indiana, 46168, United States

Location

Galderma Investigational Site (# 8532)

Overland Park, Kansas, 66215, United States

Location

Galderma Investigational Site (# 8069)

Louisville, Kentucky, 40202, United States

Location

Galderma Investigational Site (8092)

Louisville, Kentucky, 40217, United States

Location

Galderma Investigational Site (8545)

Owensboro, Kentucky, 42301, United States

Location

Galderma Investigational Site (8457)

Monroe, Louisiana, 71203, United States

Location

Galderma Investigational site (8580)

New Orleans, Louisiana, 70130, United States

Location

Galderma Investigational Site (# 8012)

Glenn Dale, Maryland, 20769, United States

Location

Galderma Investigational Site (# 8525)

Rockville, Maryland, 20850, United States

Location

Galderma Investigational Site (# 8541)

Quincy, Massachusetts, 02169, United States

Location

Galderma Investigational Site (#8512)

Bay City, Michigan, 48706, United States

Location

Galderma Investigational Site (8574)

Clarkston, Michigan, 48346, United States

Location

Galderma Investigational Site (#8033)

Clinton Township, Michigan, 48038, United States

Location

Galderma Investigational Site (8129)

Fort Gratiot, Michigan, 48059, United States

Location

Galderma Investigational Site (# 8226)

Warren, Michigan, 48088, United States

Location

Galderma Investigational Site (# 8521)

Saint Joseph, Missouri, 64506, United States

Location

Galderma Investigational Site (#8027)

St Louis, Missouri, 63141, United States

Location

Galderma Investigational Site (# 8544)

Lincoln, Nebraska, 68502, United States

Location

Galderma Investigational Site (# 8108)

Las Vegas, Nevada, 89144, United States

Location

Galderma Investigational Site (#8420)

Newington, New Hampshire, 03801, United States

Location

Galderma Investigational Site (# 8506)

Hackensack, New Jersey, 07601, United States

Location

Galderma Investigational Site (#8500)

Brooklyn, New York, 11203, United States

Location

Galderma Investigational Site (8524)

East Setauket, New York, 11733, United States

Location

Galderma Investigational Site (8568)

New York, New York, 10022, United States

Location

Galderma Investigational Site (8585)

New York, New York, 10028, United States

Location

Galderma Investigational Site (8279)

New York, New York, 10075, United States

Location

Galderma Investigational Site (8566)

Charlotte, North Carolina, 28277, United States

Location

Galderma Investigational Site (#8514)

Hickory, North Carolina, 28602, United States

Location

Galderma Investigational Site (# 8195)

Beachwood, Ohio, 44122, United States

Location

Galderma Investigational Site (# 8016)

Cincinnati, Ohio, 45255, United States

Location

Galderma Investigational site (8595)

Dublin, Ohio, 43016, United States

Location

Galderma Investigational Site (8188)

Hershey, Pennsylvania, 17033, United States

Location

Galderma Investigational site (8353)

Yardley, Pennsylvania, 19067, United States

Location

Galderma Investigational Site (# 8369)

Charleston, South Carolina, 29414, United States

Location

Galderma Investigational Site (# 8117)

Knoxville, Tennessee, 37917, United States

Location

Galderma Investigational Site (# 8515)

Nashville, Tennessee, 37203, United States

Location

Galderma Investigational Site (# 8542)

Arlington, Texas, 76017, United States

Location

Galderma Investigational Site (#8513)

Austin, Texas, 78705, United States

Location

Galderma Investigational site (8579)

Beaumont, Texas, 77701, United States

Location

Galderma Investigational Site (# 8245)

Dallas, Texas, 75231, United States

Location

Galderma Investigational Site (8183)

Houston, Texas, 77030, United States

Location

Galderma Investigational site (8576)

Katy, Texas, 77949, United States

Location

Galderma Investigational Site (8583)

Murphy, Texas, 75094, United States

Location

Galderma Investigational Site (8567)

San Antonio, Texas, 78213, United States

Location

Galderma Investigational site (8433)

San Antonio, Texas, 78218, United States

Location

Galderma Investigational site (8329)

San Antonio, Texas, 78229, United States

Location

Galderma Investigational site (8106)

Layton, Utah, 84041, United States

Location

Galderma Investigational Site (# 8214)

Salt Lake City, Utah, 84117, United States

Location

Galderma Investigational Site (# 8351)

Seattle, Washington, 98104, United States

Location

Galderma Investigational Site (# 8215)

Calgary, Alberta, T3A 2N1, Canada

Location

Galderma Investigational site (8161)

Surrey, British Columbia, V3V 0C6, Canada

Location

Galderma Investigational Site (# 8154)

Winnipeg, Manitoba, R3C 0N2, Canada

Location

Galderma Investigational Site (8586)

Barrie, Ontario, L4M 7G1, Canada

Location

Galderma Investigational Site (# 8038)

Hamilton, Ontario, L8N 1V6, Canada

Location

Galderma Investigational Site (# 8426)

London, Ontario, N5X 2P1, Canada

Location

Galderma Investigational Site (# 8026)

Markham, Ontario, L3P 1X2, Canada

Location

Galderma Investigational Site (# 8135)

North Bay, Ontario, P1B 3Z7, Canada

Location

Galderma Investigational Site (# 8168)

Oakville, Ontario, L6J 7W5, Canada

Location

Galderma Investigational Site (# 8340)

Peterborough, Ontario, K9J 5K2, Canada

Location

Galderma Investigational Site (# 8338)

Richmond Hill, Ontario, L4B 1A5, Canada

Location

Galderma Investigational Site (8001)

Waterloo, Ontario, N2J 1C4, Canada

Location

Galderma Investigational Site (# 8060)

Windsor, Ontario, N8W 5L7, Canada

Location

Galderma Investigational Site (5566)

Augsburg, 86179, Germany

Location

Galderma Investigational Site (5604)

Berlin, 10117, Germany

Location

Galderma Investigational Site (5815)

Berlin, 13507, Germany

Location

Galderma Investigational Site (5750)

Darmstadt, 64283, Germany

Location

Galderma Investigational Site (5572)

Dessau, 6847, Germany

Location

Galderma Investigational Site (5204)

Dresden, 1097, Germany

Location

Galderma Investigational Site (5434)

Dresden, 1307, Germany

Location

Galderma Investigational Site (5146)

Eberstadt, 64297, Germany

Location

Galderma Investigational Site (5838)

Hamburg, 20354, Germany

Location

Galderma Investigational Site (5635)

Langenau, 89129, Germany

Location

Galderma Investigational Site (5543)

Mainz, 55131, Germany

Location

Galderma Investigational Site (5307)

Münster, 48149, Germany

Location

Galderma Investigational Site (5802)

Balatonfüred, 08230, Hungary

Location

Galderma Investigational Site (5567)

Budapest, 01036, Hungary

Location

Galderma Investigational Site (5812)

Budapest, 01125, Hungary

Location

Galderma Investigational Site (5685)

Cegléd, 02700, Hungary

Location

Galderma Investigational Site (5254)

Nyíregyháza, 4400, Hungary

Location

Galderma Investigational Site (5811)

Pécel, 02119, Hungary

Location

Galderma Investigational Site (5263)

Püspökladány, 4150, Hungary

Location

Galderma Investigational Site (5237)

Szeged, 6720, Hungary

Location

Galderma Investigational Site (5767)

Szekszàrd, 07100, Hungary

Location

Galderma Investigational Site (8592)

Aibonito, 705, Puerto Rico

Location

Galderma Investigational Site (8594)

Caguas, 727, Puerto Rico

Location

Galderma Investigational site (8100)

Carolina, 985, Puerto Rico

Location

Galderma Investigational Site (8593)

San Juan, 00909-3004, Puerto Rico

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

trifarotene

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Results Point of Contact

• Title: Anne Fulton
• Organization: Galderma S.A.

anne.fulton@galderma.com

+1 817-961-5203

Study Officials

• Jerry Tan, MD

  Windsor Clinical Research

  PRINCIPAL INVESTIGATOR

• Ulrike Blume-Peytavi, MD

  Charité Universitätsmedizin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2015
• First Posted: October 2, 2015
• Study Start: November 30, 2015
• Primary Completion: November 14, 2017
• Study Completion: November 14, 2017
• Last Updated: November 12, 2019
• Results First Posted: August 22, 2019

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (13); PR (4); HU (9); US (86); DE (12)