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: NCT02566369
• Collaborator: (none)
• Enrollment: 1,208
• Locations: 124
• Arms: 2
• Actual Duration (Months): 23.5
• Patients Per Site: 9.7
• Patients Per Site Per Month: 0.4

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

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 1208 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
• Actual Study Start Date: Nov 30, 2015
• Actual Primary Completion Date: Nov 14, 2017
• Actual Study Completion Date: Nov 14, 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 for 12 weeks.
Placebo Comparator: Placebo Cream Placebo cream	Drug: Placebo cream; Placebo cream applied once daily for 12 weeks

Outcome Measures

Primary Outcome Measures

1. Investigator Global Assessment (IGA) Success Rate at Week 12 [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 (8258)	Mobile	Alabama	United States	36608
2	Galderma Investigational Site (# 8530)	Glendale	Arizona	United States	85308
3	Galderma Investigational Site (# 8511)	Phoenix	Arizona	United States	85018
4	Galderma Investigational Site (# 8009)	Hot Springs	Arkansas	United States	71913
5	Galderma Investigational Site (# 8355)	Rogers	Arkansas	United States	72758
6	Galderma Investigational Site (# 8456)	Beverly Hills	California	United States	90212
7	Galderma Investigational site (8578)	Cerritos	California	United States	90703
8	Galderma Investigational Site (# 8526)	Clovis	California	United States	93612
9	Galderma Investigational Site (8577)	Encinitas	California	United States	92024
10	Galderma Investigational Site (# 8224)	Fremont	California	United States	94538
11	Galderma Investigational Site (# 8509)	Fullerton	California	United States	92835
12	Galderma Investigational Site (# 8507)	Huntington Beach	California	United States	92647
13	Galderma Investigational Site (# 8425)	Newport Beach	California	United States	92663
14	Galderma Investigational Site (# 8052)	Oceanside	California	United States	92056
15	Galderma Investigational Site (# 8528)	Santa Ana	California	United States	92701
16	Galderma Investigational Site (# 8160)	Santa Monica	California	United States	91301
17	Galderma Investigational Site (# 8443)	Temecula	California	United States	92592
18	Galderma Investigational Site (8572)	Colorado Springs	Colorado	United States	80920
19	Galderma Investigational Site (# 8510)	Englewood	Colorado	United States	80113
20	Galderma Investigational Site (# 8370)	Boynton Beach	Florida	United States	33437
21	Galderma Investigational Site (# 8543)	Fort Lauderdale	Florida	United States	33316
22	Galderma Investigational Site (8143)	Miami	Florida	United States	33175
23	Galderma Investigational site (8259)	Miramar	Florida	United States	33027
24	Galderma Investigational Site (# 8522)	North Miami Beach	Florida	United States	33162
25	Galderma Investigational Site (# 8531)	Orange Park	Florida	United States	32073
26	Galderma Investigational Site (8502)	Orlando	Florida	United States	32814
27	Galderma Investigational Site (#8213)	Ormond Beach	Florida	United States	32174
28	Galderma Investigational Site (# 8455)	Saint Petersburg	Florida	United States	33708
29	Galderma Investigational Site (# 8529)	Sanford	Florida	United States	32771
30	Galderma Investigational Site (# 8523)	Tampa	Florida	United States	33609
31	Galderma Investigational Site (# 8126)	West Palm Beach	Florida	United States	33401
32	Galderma Investigational Site (#8189)	Snellville	Georgia	United States	30078
33	Galderma Investigational Site (8582)	Idaho Falls	Idaho	United States	83404
34	Galderma Investigational Site (# 8367)	Arlington Heights	Illinois	United States	60005
35	Galderma Investigational Site (8191)	Chicago	Illinois	United States	60611
36	Galderma Investigational site (8571)	Darien	Illinois	United States	60561
37	Galderma Investigational Site (8575)	Oakbrook Terrace	Illinois	United States	60180
38	Galderma Investigational Site (# 8366)	Plainfield	Indiana	United States	46168
39	Galderma Investigational Site (# 8532)	Overland Park	Kansas	United States	66215
40	Galderma Investigational Site (# 8069)	Louisville	Kentucky	United States	40202
41	Galderma Investigational Site (8092)	Louisville	Kentucky	United States	40217
42	Galderma Investigational Site (8545)	Owensboro	Kentucky	United States	42301
43	Galderma Investigational Site (8457)	Monroe	Louisiana	United States	71203
44	Galderma Investigational site (8580)	New Orleans	Louisiana	United States	70130
45	Galderma Investigational Site (# 8012)	Glenn Dale	Maryland	United States	20769
46	Galderma Investigational Site (# 8525)	Rockville	Maryland	United States	20850
47	Galderma Investigational Site (# 8541)	Quincy	Massachusetts	United States	02169
48	Galderma Investigational Site (#8512)	Bay City	Michigan	United States	48706
49	Galderma Investigational Site (8574)	Clarkston	Michigan	United States	48346
50	Galderma Investigational Site (#8033)	Clinton Township	Michigan	United States	48038
51	Galderma Investigational Site (8129)	Fort Gratiot	Michigan	United States	48059
52	Galderma Investigational Site (# 8226)	Warren	Michigan	United States	48088
53	Galderma Investigational Site (# 8521)	Saint Joseph	Missouri	United States	64506
54	Galderma Investigational Site (#8027)	Saint Louis	Missouri	United States	63141
55	Galderma Investigational Site (# 8544)	Lincoln	Nebraska	United States	68502
56	Galderma Investigational Site (# 8108)	Las Vegas	Nevada	United States	89144
57	Galderma Investigational Site (#8420)	Newington	New Hampshire	United States	03801
58	Galderma Investigational Site (# 8506)	Hackensack	New Jersey	United States	07601
59	Galderma Investigational Site (#8500)	Brooklyn	New York	United States	11203
60	Galderma Investigational Site (8524)	East Setauket	New York	United States	11733
61	Galderma Investigational Site (8568)	New York	New York	United States	10022
62	Galderma Investigational Site (8585)	New York	New York	United States	10028
63	Galderma Investigational Site (8279)	New York	New York	United States	10075
64	Galderma Investigational Site (8566)	Charlotte	North Carolina	United States	28277
65	Galderma Investigational Site (#8514)	Hickory	North Carolina	United States	28602
66	Galderma Investigational Site (# 8195)	Beachwood	Ohio	United States	44122
67	Galderma Investigational Site (# 8016)	Cincinnati	Ohio	United States	45255
68	Galderma Investigational site (8595)	Dublin	Ohio	United States	43016
69	Galderma Investigational Site (8188)	Hershey	Pennsylvania	United States	17033
70	Galderma Investigational site (8353)	Yardley	Pennsylvania	United States	19067
71	Galderma Investigational Site (# 8369)	Charleston	South Carolina	United States	29414
72	Galderma Investigational Site (# 8117)	Knoxville	Tennessee	United States	37917
73	Galderma Investigational Site (# 8515)	Nashville	Tennessee	United States	37203
74	Galderma Investigational Site (# 8542)	Arlington	Texas	United States	76017
75	Galderma Investigational Site (#8513)	Austin	Texas	United States	78705
76	Galderma Investigational site (8579)	Beaumont	Texas	United States	77701
77	Galderma Investigational Site (# 8245)	Dallas	Texas	United States	75231
78	Galderma Investigational Site (8183)	Houston	Texas	United States	77030
79	Galderma Investigational site (8576)	Katy	Texas	United States	77949
80	Galderma Investigational Site (8583)	Murphy	Texas	United States	75094
81	Galderma Investigational Site (8567)	San Antonio	Texas	United States	78213
82	Galderma Investigational site (8433)	San Antonio	Texas	United States	78218
83	Galderma Investigational site (8329)	San Antonio	Texas	United States	78229
84	Galderma Investigational site (8106)	Layton	Utah	United States	84041
85	Galderma Investigational Site (# 8214)	Salt Lake City	Utah	United States	84117
86	Galderma Investigational Site (# 8351)	Seattle	Washington	United States	98104
87	Galderma Investigational Site (# 8215)	Calgary	Alberta	Canada	T3A 2N1
88	Galderma Investigational site (8161)	Surrey	British Columbia	Canada	V3V 0C6
89	Galderma Investigational Site (# 8154)	Winnipeg	Manitoba	Canada	R3C 0N2
90	Galderma Investigational Site (8586)	Barrie	Ontario	Canada	L4M 7G1
91	Galderma Investigational Site (# 8038)	Hamilton	Ontario	Canada	L8N 1V6
92	Galderma Investigational Site (# 8426)	London	Ontario	Canada	N5X 2P1
93	Galderma Investigational Site (# 8026)	Markham	Ontario	Canada	L3P 1X2
94	Galderma Investigational Site (# 8135)	North Bay	Ontario	Canada	P1B 3Z7
95	Galderma Investigational Site (# 8168)	Oakville	Ontario	Canada	L6J 7W5
96	Galderma Investigational Site (# 8340)	Peterborough	Ontario	Canada	K9J 5K2
97	Galderma Investigational Site (# 8338)	Richmond Hill	Ontario	Canada	L4B 1A5
98	Galderma Investigational Site (8001)	Waterloo	Ontario	Canada	N2J 1C4
99	Galderma Investigational Site (# 8060)	Windsor	Ontario	Canada	N8W 5L7
100	Galderma Investigational Site (5566)	Augsburg		Germany	86179
101	Galderma Investigational Site (5604)	Berlin		Germany	10117
102	Galderma Investigational Site (5815)	Berlin		Germany	13507
103	Galderma Investigational Site (5750)	Darmstadt		Germany	64283
104	Galderma Investigational Site (5572)	Dessau		Germany	6847
105	Galderma Investigational Site (5204)	Dresden		Germany	1097
106	Galderma Investigational Site (5434)	Dresden		Germany	1307
107	Galderma Investigational Site (5146)	Eberstadt		Germany	64297
108	Galderma Investigational Site (5838)	Hamburg		Germany	20354
109	Galderma Investigational Site (5635)	Langenau		Germany	89129
110	Galderma Investigational Site (5543)	Mainz		Germany	55131
111	Galderma Investigational Site (5307)	Münster		Germany	48149
112	Galderma Investigational Site (5802)	Balatonfüred		Hungary	08230
113	Galderma Investigational Site (5567)	Budapest		Hungary	01036
114	Galderma Investigational Site (5812)	Budapest		Hungary	01125
115	Galderma Investigational Site (5685)	Cegléd		Hungary	02700
116	Galderma Investigational Site (5254)	Nyíregyháza		Hungary	4400
117	Galderma Investigational Site (5811)	Pécel		Hungary	02119
118	Galderma Investigational Site (5263)	Püspökladány		Hungary	4150
119	Galderma Investigational Site (5237)	Szeged		Hungary	6720
120	Galderma Investigational Site (5767)	Szekszàrd		Hungary	07100
121	Galderma Investigational Site (8592)	Aibonito		Puerto Rico	705
122	Galderma Investigational Site (8594)	Caguas		Puerto Rico	727
123	Galderma Investigational site (8100)	Carolina		Puerto Rico	985
124	Galderma Investigational Site (8593)	San Juan		Puerto Rico	00909-3004

Sponsors and Collaborators

• Galderma R&D

Investigators

• Principal Investigator: Jerry Tan, MD, Windsor Clinical Research
• Principal Investigator: Ulrike Blume-Peytavi, MD, Charité Universitätsmedizin

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: NCT02566369
• Other Study ID Numbers: RD.06.SPR.18251
• First Posted: Oct 2, 2015
• Last Update Posted: Nov 12, 2019
• Last Verified: Jul 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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 for 12 weeks.	Placebo cream applied once daily for 12 weeks
Period Title: Overall Study
STARTED	612	596
COMPLETED	540	535
NOT COMPLETED	72	61

Baseline Characteristics

Arm/Group Title	CD5789 (Trifarotene) 50μg/g Cream	Placebo Cream	Total
Arm/Group Description	CD5789 (trifarotene) 50µg/g cream applied once daily for 12 weeks.	Placebo cream applied once daily for 12 weeks	Total of all reporting groups
Overall Participants	612	596	1208
Age (Count of Participants)
<=18 years	314 51.3%	278 46.6%	592 49%
Between 18 and 65 years	298 48.7%	318 53.4%	616 51%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	305 49.8%	324 54.4%	629 52.1%
Male	307 50.2%	272 45.6%	579 47.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	135 22.1%	148 24.8%	283 23.4%
Not Hispanic or Latino	477 77.9%	448 75.2%	925 76.6%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	11 1.8%	5 0.8%	16 1.3%
Asian	23 3.8%	32 5.4%	55 4.6%
Native Hawaiian or Other Pacific Islander	1 0.2%	1 0.2%	2 0.2%
Black or African American	47 7.7%	49 8.2%	96 7.9%
White	508 83%	484 81.2%	992 82.1%
More than one race	8 1.3%	10 1.7%	18 1.5%
Unknown or Not Reported	14 2.3%	15 2.5%	29 2.4%
Region of Enrollment (participants) [Number]
Canada	70 11.4%	69 11.6%	139 11.5%
Puerto Rico	27 4.4%	28 4.7%	55 4.6%
Hungary	44 7.2%	44 7.4%	88 7.3%
United States	407 66.5%	395 66.3%	802 66.4%
Germany	64 10.5%	60 10.1%	124 10.3%
Physician Global Assessment Scale Face (Count of Participants)
Clear	0 0%	0 0%	0 0%
Almost Clear	0 0%	0 0%	0 0%
Mild	0 0%	0 0%	0 0%
Moderate	612 100%	596 100%	1208 100%
Severe	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Investigator Global Assessment (IGA) Success Rate at Week 12
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 for 12 weeks.	Placebo cream applied once daily for 12 weeks
Measure Participants	612	596
Count of Participants [Participants]	180 29.4%	116 19.5%

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 for 12 weeks.		Placebo cream applied once daily for 12 weeks
All Cause Mortality
	CD5789 (Trifarotene) 50μg/g Cream		Placebo Cream
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/612 (0%)		0/596 (0%)
Serious Adverse Events
	CD5789 (Trifarotene) 50μg/g Cream		Placebo Cream
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/612 (0.7%)		2/596 (0.3%)
Congenital, familial and genetic disorders
Hereditary angioedema	0/612 (0%)		1/596 (0.2%)
Infections and infestations
Infectious Mononucleosis	1/612 (0.2%)		0/596 (0%)
Cellulitis	1/612 (0.2%)		0/596 (0%)
Atypical Pneumonia	0/612 (0%)		1/596 (0.2%)
Injury, poisoning and procedural complications
Facial Bones Fracture	1/612 (0.2%)		0/596 (0%)
Procedural dizziness	1/612 (0.2%)		0/596 (0%)
Renal and urinary disorders
Urinary Tract Infection	0/612 (0%)		1/596 (0.2%)
Other (Not Including Serious) Adverse Events
	CD5789 (Trifarotene) 50μg/g Cream		Placebo Cream
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	177/612 (28.9%)		74/596 (12.4%)
General disorders
Application Site Irritation	66/612 (10.8%)		4/596 (0.7%)
Application Site Pruritis	24/612 (3.9%)		8/596 (1.3%)
Infections and infestations
Nasopharyngitis	24/612 (3.9%)		27/596 (4.5%)
Upper Respiratory Tract Infection	10/612 (1.6%)		8/596 (1.3%)
Influenza	6/612 (1%)		9/596 (1.5%)
Sinusitis	6/612 (1%)		1/596 (0.2%)
Injury, poisoning and procedural complications
Sunburn	27/612 (4.4%)		5/596 (0.8%)
Nervous system disorders
Headache	6/612 (1%)		12/596 (2%)
Skin and subcutaneous tissue disorders
Skin Irritation	8/612 (1.3%)		0/596 (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.