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

NCT02556788 | Completed Phase 3 Results

• 1 other identifier: RD.06.SPR.18252
• Study Type: interventional
• Target: 1,212
• Locations: 8 countries
• Sites: 81

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) 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.

  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 during 12 weeks.

CD5789 (Trifarotene) 50µg/g Cream

Placebo Cream DRUG

Placebo cream applied once daily during 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 (81)

Galderma Investigational Site

Birmingham, Alabama, 35205, United States

Location

Galderma Investigational Site

Phoenix, Arizona, 85032, United States

Location

Galderma Investigational Site

Tucson, Arizona, 85712, United States

Location

Galderma Investigational Site

Fort Smith, Arkansas, 72916, United States

Location

Galderma Investigational Site

Los Angeles, California, 90036, United States

Location

Galderma Investigational Site

Murrieta, California, 92562, United States

Location

Galderma Investigational Site

Santa Ana, California, 92705, United States

Location

Galderma Investigational Site

Aventura, Florida, 33180, United States

Location

Galderma Investigational Site

Miami, Florida, 33144, United States

Location

Galderma Investigational Site

Miami Lakes, Florida, 33016, United States

Location

Galderma Investigational Site

West Palm Beach, Florida, 33406, United States

Location

Galderma Investigational Site

Corbin, Kentucky, 40701, United States

Location

Galderma Investigational Site

Beverly, Massachusetts, 01915, United States

Location

Galderma Investigational Site

Ann Arbor, Michigan, 48103, United States

Location

Galderma Investigational Site

Detroit, Michigan, 48202, United States

Location

Galderma Investigational Site

Brooklyn, New York, 11203, United States

Location

Galderma Investigational Site

Stony Brook, New York, 11790, United States

Location

Galderma Investigational Site

Wilmington, North Carolina, 28401, United States

Location

Galderma Investigational Site

Fort Washington, Pennsylvania, 19034, United States

Location

Galderma Investigational Site

Philadelphia, Pennsylvania, 19103, United States

Location

Galderma Investigational Site

Greer, South Carolina, 29650, United States

Location

Galderma Investigational Site

Goodlettsville, Tennessee, 37072, United States

Location

Galderma Invetsigational site

Austin, Texas, 78759-8858, United States

Location

Galderma Investigational Site

Dallas, Texas, 75230-5806, United States

Location

Galderma Investigational Site

Houston, Texas, 77004, United States

Location

Galderma Investigational Site

Pflugerville, Texas, 78660, United States

Location

Galderma Investigational Site

San Antonio, Texas, 78249, United States

Location

Galderma Investigational Site

Webster, Texas, 77598, United States

Location

Galderma Investigational Site

Walla Walla, Washington, 99362, United States

Location

Galderma Investigational Site

Chomutov, 430 04, Czechia

Location

Galderma Investigational Site

Hradec Králové, 500 05, Czechia

Location

Galderma Investigational Site

Kutná Hora, 284 01, Czechia

Location

Galderma Investigational Site

Olomouc, 775 20, Czechia

Location

Galderma Investigational Site

Pardubice, 532 03, Czechia

Location

Galderma Investigational Site

Prague, 11 000, Czechia

Location

Galderma Investigational Site

Prague, 110 00, Czechia

Location

Galderma Investigational Site

Prague, 190 11, Czechia

Location

Galderma Investigational Site

Budapest, 1035, Hungary

Location

Galderma Investigational Site

Budapest, 1089, Hungary

Location

Galderma Investigational Site

Debrecen, 4032, Hungary

Location

Galderma Investigational Site

Miskolc, 3529, Hungary

Location

Galderma Investigational Site

Pécs, 7632, Hungary

Location

Galderma Investigational Site

Szeged, 6720, Hungary

Location

Galderma Investigational Site

Szolnok, 5000, Hungary

Location

Galderma Investigational Site

Bialystok, 15-453, Poland

Location

Galderma Investigational Site

Gdansk, 80-152, Poland

Location

Galderma Investigational Site

Gdansk, 80-402, Poland

Location

Galderma Investigational Site

Gdansk, 80-546, Poland

Location

Galderma Investigational Site

Katowice, 40-036, Poland

Location

Galderma investigational Site

Katowice, 40-611, Poland

Location

Galderma Investigational Site

Katowice, 40-851, Poland

Location

Galderma Investigational Site

Lodz, 90-242, Poland

Location

Galderma Investigational Site

Sochaczew, 95-500, Poland

Location

Galderma Investigational Site

Warsaw, 01-817, Poland

Location

Galderma investigational Site

Warsaw, 02-657, Poland

Location

Galderma Investigational Site

Warsaw, 02-758, Poland

Location

Galderma Investigational Site

Wroclaw, 51-318, Poland

Location

Galderma Investigational Site

Wroclaw, 53-658, Poland

Location

Galderma Investigational Site

Brasov, 500283, Romania

Location

Galderma Investigational Site

Craiova, 200642, Romania

Location

Galderma Investigational Site

Iași, 700381, Romania

Location

Galderma Investigational Site

Târgu Mureş, 540530, Romania

Location

Galderma Investigational Site

Krasnodar, 3500 20, Russia

Location

Galderma Investigational Site

Lipetsk, 398035, Russia

Location

Galderma Investigational Site

Moscow, 107076, Russia

Location

Galderma Investigational Site

Moscow, 119071, Russia

Location

Galderma Investigational Site

Moscow, 121614, Russia

Location

Galderma Investigational Site

Saint Petersburg, 194100, Russia

Location

Galderma Investigational Site

Sr Petersburg, 194021, Russia

Location

Galderma Investigational Site

Barcelona, 08206, Spain

Location

Galderma Investigational Site

Esplugues de Llobregat, 8950, Spain

Location

Galderma Investigational site

Madrid, 28009, Spain

Location

Galderma Investigational Site

Valencia, 46014, Spain

Location

Galderma Investigational Site

Dnipropetrovsk, 49044, Ukraine

Location

Galderma Investigational Site

Dnipropetrovsk, 49074, Ukraine

Location

Galderma Investigational Site

Ivano-Frankivsk, 76000, Ukraine

Location

Galderma Investigational Site

Kharkiv, 61057, Ukraine

Location

Galderma Investigational Site

Kyiv, 01601, Ukraine

Location

Galderma Investigational Site

Kyiv, 04209, Ukraine

Location

Galderma Investigational Site

Lviv, 79049, Ukraine

Location

Galderma Investigational Site

Uzhhorod, 88000, Ukraine

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

• Kevin Chan

  Galderma R&D

  STUDY DIRECTOR

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: September 18, 2015
• First Posted: September 22, 2015
• Study Start: November 1, 2015
• Primary Completion: February 7, 2017
• Study Completion: May 12, 2017
• Last Updated: November 12, 2019
• Results First Posted: September 3, 2019

Record last verified: 2018-07

Locations

UA (8); RO (4); ES (4); HU (7); CZ (8); PL (14); RU (7); US (29)