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

• Sponsor: Galderma R&D (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02556788
• Collaborator: (none)
• Enrollment: 1,212
• Locations: 81
• Arms: 2
• Duration (Months): 18.3
• Patients Per Site: 15
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris	Drug: CD5789 (trifarotene) 50µg/g Cream; Drug: Placebo Cream	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 1212 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Study Start Date: Nov 1, 2015
• Actual Primary Completion Date: Feb 7, 2017
• Actual Study Completion Date: May 12, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CD5789 (Trifarotene) 50µg/g Cream CD5789 (trifarotene) 50µg/g Cream	Drug: CD5789 (trifarotene) 50µg/g Cream; CD5789 (Trifarotene) 50µg/g cream applied once daily during 12 weeks.
Placebo Comparator: Placebo Cream Placebo Cream	Drug: Placebo Cream; Placebo cream applied once daily during 12 weeks.

Outcome Measures

Primary Outcome Measures

1. Investigator Global Assessment (IGA) Score of 1 (Almost Clear) or 0 (Clear) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 9 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Galderma Investigational Site	Birmingham	Alabama	United States	35205
2	Galderma Investigational Site	Phoenix	Arizona	United States	85032
3	Galderma Investigational Site	Tucson	Arizona	United States	85712
4	Galderma Investigational Site	Fort Smith	Arkansas	United States	72916
5	Galderma Investigational Site	Los Angeles	California	United States	90036
6	Galderma Investigational Site	Murrieta	California	United States	92562
7	Galderma Investigational Site	Santa Ana	California	United States	92705
8	Galderma Investigational Site	Aventura	Florida	United States	33180
9	Galderma Investigational Site	Miami Lakes	Florida	United States	33016
10	Galderma Investigational Site	Miami	Florida	United States	33144
11	Galderma Investigational Site	West Palm Beach	Florida	United States	33406
12	Galderma Investigational Site	Corbin	Kentucky	United States	40701
13	Galderma Investigational Site	Beverly	Massachusetts	United States	01915
14	Galderma Investigational Site	Ann Arbor	Michigan	United States	48103
15	Galderma Investigational Site	Detroit	Michigan	United States	48202
16	Galderma Investigational Site	Brooklyn	New York	United States	11203
17	Galderma Investigational Site	Stony Brook	New York	United States	11790
18	Galderma Investigational Site	Wilmington	North Carolina	United States	28401
19	Galderma Investigational Site	Fort Washington	Pennsylvania	United States	19034
20	Galderma Investigational Site	Philadelphia	Pennsylvania	United States	19103
21	Galderma Investigational Site	Greer	South Carolina	United States	29650
22	Galderma Investigational Site	Goodlettsville	Tennessee	United States	37072
23	Galderma Invetsigational site	Austin	Texas	United States	78759-8858
24	Galderma Investigational Site	Dallas	Texas	United States	75230-5806
25	Galderma Investigational Site	Houston	Texas	United States	77004
26	Galderma Investigational Site	Pflugerville	Texas	United States	78660
27	Galderma Investigational Site	San Antonio	Texas	United States	78249
28	Galderma Investigational Site	Webster	Texas	United States	77598
29	Galderma Investigational Site	Walla Walla	Washington	United States	99362
30	Galderma Investigational Site	Chomutov		Czechia	430 04
31	Galderma Investigational Site	Hradec Kralove		Czechia	500 05
32	Galderma Investigational Site	Kutna Hora		Czechia	284 01
33	Galderma Investigational Site	Olomouc		Czechia	775 20
34	Galderma Investigational Site	Pardubice		Czechia	532 03
35	Galderma Investigational Site	Praha 1		Czechia	11 000
36	Galderma Investigational Site	Praha 1		Czechia	110 00
37	Galderma Investigational Site	Praha		Czechia	190 11
38	Galderma Investigational Site	Budapest		Hungary	1035
39	Galderma Investigational Site	Budapest		Hungary	1089
40	Galderma Investigational Site	Debrecen		Hungary	4032
41	Galderma Investigational Site	Miskolc		Hungary	3529
42	Galderma Investigational Site	Pecs		Hungary	7632
43	Galderma Investigational Site	Szeged		Hungary	6720
44	Galderma Investigational Site	Szolnok		Hungary	5000
45	Galderma Investigational Site	Bialystok		Poland	15-453
46	Galderma Investigational Site	Gdansk		Poland	80-152
47	Galderma Investigational Site	Gdansk		Poland	80-402
48	Galderma Investigational Site	Gdansk		Poland	80-546
49	Galderma Investigational Site	Katowice		Poland	40-036
50	Galderma investigational Site	Katowice		Poland	40-611
51	Galderma Investigational Site	Katowice		Poland	40-851
52	Galderma Investigational Site	Lodz		Poland	90-242
53	Galderma Investigational Site	Sochaczew		Poland	95-500
54	Galderma Investigational Site	Warszawa		Poland	01-817
55	Galderma investigational Site	Warszawa		Poland	02-657
56	Galderma Investigational Site	Warszawa		Poland	02-758
57	Galderma Investigational Site	Wroclaw		Poland	51-318
58	Galderma Investigational Site	Wroclaw		Poland	53-658
59	Galderma Investigational Site	Brasov		Romania	500283
60	Galderma Investigational Site	Craiova		Romania	200642
61	Galderma Investigational Site	Iasi		Romania	700381
62	Galderma Investigational Site	Târgu-Mureş		Romania	540530
63	Galderma Investigational Site	Krasnodar		Russian Federation	3500 20
64	Galderma Investigational Site	Lipetsk		Russian Federation	398035
65	Galderma Investigational Site	Moscow		Russian Federation	107076
66	Galderma Investigational Site	Moscow		Russian Federation	119071
67	Galderma Investigational Site	Moscow		Russian Federation	121614
68	Galderma Investigational Site	Sr Petersburg		Russian Federation	194021
69	Galderma Investigational Site	St Petersburg		Russian Federation	194100
70	Galderma Investigational Site	Barcelona		Spain	08206
71	Galderma Investigational Site	Esplugues de Llobregat		Spain	8950
72	Galderma Investigational site	Madrid		Spain	28009
73	Galderma Investigational Site	Valencia		Spain	46014
74	Galderma Investigational Site	Dnipropetrovsk		Ukraine	49044
75	Galderma Investigational Site	Dnipropetrovsk		Ukraine	49074
76	Galderma Investigational Site	Ivano-Frankivsk		Ukraine	76000
77	Galderma Investigational Site	Kharkiv		Ukraine	61057
78	Galderma Investigational Site	Kyiv		Ukraine	01601
79	Galderma Investigational Site	Kyiv		Ukraine	04209
80	Galderma Investigational Site	Lviv		Ukraine	79049
81	Galderma Investigational Site	Uzhgorod		Ukraine	88000

Sponsors and Collaborators

• Galderma R&D

Investigators

• Study Director: Kevin Chan, Galderma R&D

Study Documents (Full-Text)

• Study Protocol - Mar 10, 2017
• Statistical Analysis Plan - Oct 5, 2015

More Information

Publications

None provided.

• Responsible Party: Galderma R&D
• ClinicalTrials.gov Identifier: NCT02556788
• Other Study ID Numbers: RD.06.SPR.18252
• First Posted: Sep 22, 2015
• Last Update Posted: Nov 12, 2019
• Last Verified: Jul 1, 2018

• Keywords provided by Galderma R&D: Efficacy; Safety; Acne vulgaris
• Additional relevant MeSH terms: Acne Vulgaris; Trifarotene

Study Results

Participant Flow

Arm/Group Title	CD5789 (Trifarotene) 50µg/g Cream	Placebo Cream
Arm/Group Description	CD5789 (Trifarotene) 50µg/g cream applied once daily during 12 weeks.	Placebo cream applied once daily during 12 weeks.
Period Title: Overall Study
STARTED	602	610
COMPLETED	558	573
NOT COMPLETED	44	37

Baseline Characteristics

Arm/Group Title	CD5789 (Trifarotene) 50µg/g Cream	Placebo Cream	Total
Arm/Group Description	CD5789 (Trifarotene) 50µg/g cream applied once daily during 12 weeks.	Placebo cream applied once daily during 12 weeks.	Total of all reporting groups
Overall Participants	602	610	1212
Age (Count of Participants)
<=18 years	276 45.8%	294 48.2%	570 47%
Between 18 and 65 years	326 54.2%	316 51.8%	642 53%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	357 59.3%	338 55.4%	695 57.3%
Male	245 40.7%	272 44.6%	517 42.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	60 10%	62 10.2%	122 10.1%
Not Hispanic or Latino	542 90%	548 89.8%	1090 89.9%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 0.2%	2 0.3%	3 0.2%
Asian	2 0.3%	6 1%	8 0.7%
Native Hawaiian or Other Pacific Islander	0 0%	1 0.2%	1 0.1%
Black or African American	27 4.5%	42 6.9%	69 5.7%
White	565 93.9%	554 90.8%	1119 92.3%
More than one race	2 0.3%	2 0.3%	4 0.3%
Unknown or Not Reported	5 0.8%	3 0.5%	8 0.7%
Region of Enrollment (Count of Participants)
Romania	64 10.6%	65 10.7%	129 10.6%
Hungary	74 12.3%	66 10.8%	140 11.6%
United States	124 20.6%	154 25.2%	278 22.9%
Czechia	63 10.5%	60 9.8%	123 10.1%
Ukraine	71 11.8%	74 12.1%	145 12%
Poland	92 15.3%	96 15.7%	188 15.5%
Russia	100 16.6%	81 13.3%	181 14.9%
Spain	14 2.3%	14 2.3%	28 2.3%
Investigator Global Asssessment (participants) [Number]
Clear	0 0%	0 0%	0 0%
Almost Clear	0 0%	0 0%	0 0%
Mild	0 0%	0 0%	0 0%
Moderate	602 100%	610 100%	1212 100%
Severe	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Investigator Global Assessment (IGA) Score of 1 (Almost Clear) or 0 (Clear)
Description	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.
Time Frame	From Baseline to Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CD5789 (Trifarotene) 50µg/g Cream	Placebo Cream
Arm/Group Description	CD5789 (Trifarotene) 50µg/g cream applied once daily during 12 weeks.	Placebo cream applied once daily during 12 weeks.
Measure Participants	598	609
Count of Participants [Participants]	255 42.4%	157 25.7%

Adverse Events

Time Frame	Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).
Arm/Group Title	CD5789 (Trifarotene) 50µg/g Cream		Placebo Cream
Arm/Group Description	CD5789 (Trifarotene) 50µg/g cream applied once daily during 12 weeks.		Placebo cream applied once daily during 12 weeks.
All Cause Mortality
	CD5789 (Trifarotene) 50µg/g Cream		Placebo Cream
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/602 (0%)		0/610 (0%)
Serious Adverse Events
	CD5789 (Trifarotene) 50µg/g Cream		Placebo Cream
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/602 (0.3%)		4/610 (0.7%)
Infections and infestations
Appendicitis	0/602 (0%)		1/610 (0.2%)
Sinusitis	0/602 (0%)		1/610 (0.2%)
Injury, poisoning and procedural complications
Ligament Sprain	1/602 (0.2%)		0/610 (0%)
Psychiatric disorders
Suicide Attempt	1/602 (0.2%)		1/610 (0.2%)
Major Depression	1/602 (0.2%)		0/610 (0%)
Respiratory, thoracic and mediastinal disorders
Asthma	0/602 (0%)		1/610 (0.2%)
Other (Not Including Serious) Adverse Events
	CD5789 (Trifarotene) 50µg/g Cream		Placebo Cream
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	21/602 (3.5%)		5/610 (0.8%)
Blood and lymphatic system disorders
Lymphadenopathy	1/602 (0.2%)		0/610 (0%)
Eye disorders
Eyelid Exfoliation	1/602 (0.2%)		0/610 (0%)
Eyelid Edema	1/602 (0.2%)		0/610 (0%)
Gastrointestinal disorders
Cheilitis	1/602 (0.2%)		0/610 (0%)
General disorders
Application Site Irritation	15/602 (2.5%)		0/610 (0%)
Application Site Puritis	5/602 (0.8%)		2/610 (0.3%)
Application Site Pain	4/602 (0.7%)		0/610 (0%)
Application Site Dryness	3/602 (0.5%)		0/610 (0%)
Application Site Erosion	1/602 (0.2%)		0/610 (0%)
Application Site Erythema	1/602 (0.2%)		0/610 (0%)
Infections and infestations
Herpes Simplex	1/602 (0.2%)		0/610 (0%)
Tinea Versicolor	1/602 (0.2%)		0/610 (0%)
Oral Herpes	0/602 (0%)		1/610 (0.2%)
Injury, poisoning and procedural complications
Sunburn	2/602 (0.3%)		0/610 (0%)
Drug Administered at Inappropriate Site	1/602 (0.2%)		0/610 (0%)
Investigations
Blood Bilirubin Increased	0/602 (0%)		1/610 (0.2%)
Blood Creatinine Increased	0/602 (0%)		1/610 (0.2%)
Psychiatric disorders
Insomnia	1/602 (0.2%)		0/610 (0%)
Skin and subcutaneous tissue disorders
Skin Irritation	2/602 (0.3%)		0/610 (0%)
Skin Fissures	1/602 (0.2%)		0/610 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.