Multi-center, Randomized, Double-blind Efficacy and Safety of CD0271 0.3%/CD1579 2.5 % Topical Gel in Acne Vulgaris

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ClinicalTrials.gov Identifier: NCT01880320

Recruitment Status : Completed

First Posted : June 18, 2013

Results First Posted : September 9, 2016

Last Update Posted : June 28, 2018

Sponsor:

Information provided by (Responsible Party):

Galderma R&D

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
Condition	Acne Vulgaris
Interventions	Drug: CD0271 0.3% / CD1579 2.5% Drug: CD0271 0.1% / CD1579 2.5% Drug: Topical Gel Vehicle
Enrollment	503

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	CD0271 0.3% /CD1579 2.5% Gel	CD0271 0.1% / CD1579 2.5%	Topical Gel Vehicle
Arm/Group Description	Active arm ...	Comparator arm ...	Placebo arm
Arm/Group Description	Active arm CD0271 0.3% / CD1579 2.5%	Comparator arm CD0271 0.1% / CD1579 2.5%	Placebo arm Topical Gel Vehicle
Period Title: Overall Study
Started	217	217	69
Completed	197	192	61
Not Completed	20	25	8

Baseline Characteristics

Arm/Group Title		CD0271 0.3% /CD1579 2.5% Gel	CD0271 0.1% / CD1579 2.5%	Topical Gel Vehicle	Total
Arm/Group Description		Active arm ...	Comparator arm ...	Placebo arm	Total of all reporting groups
Arm/Group Description		Active arm CD0271 0.3% / CD1579 2.5%	Comparator arm CD0271 0.1% / CD1579 2.5%	Placebo arm Topical Gel Vehicle	Total of all reporting groups
Overall Number of Baseline Participants		217	217	69	503
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Categorical Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	217 participants	217 participants	69 participants	503 participants
	<=18 years	124 57.1%	136 62.7%	43 62.3%	303 60.2%
	Between 18 and 65 years	93 42.9%	81 37.3%	26 37.7%	200 39.8%
	>=65 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	217 participants	217 participants	69 participants	503 participants
		20.1 (7.59)	19.4 (6.75)	18.5 (5.72)	19.6 (7.01)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	217 participants	217 participants	69 participants	503 participants
	Female	113 52.1%	114 52.5%	36 52.2%	263 52.3%
	Male	104 47.9%	103 47.5%	33 47.8%	240 47.7%
Region of Enrollment Measure Type: Number Unit of measure: Participants	Number Analyzed	217 participants	217 participants	69 participants	503 participants
Canada		17	16	5	38
United States		200	201	64	465
Baseline Investigator Global Assessment (IGA) Measure Type: Number Unit of measure: Participants	Number Analyzed	217 participants	217 participants	69 participants	503 participants
Baseline IGA = Moderate (3)		111	105	35	251
Baseline IGA = Severe (4)		106	112	34	252

Outcome Measures

1.Primary Outcome


Title	Success Rate
Description	Success was defined as '...
Description	Success was defined as 'Clear' or 'Almost Clear' on the Investigator Global Assessment (IGA). Success rate at Week 12 was estimated using multiple imputation approach which is an average of response from multiple imputed datasets.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT): All subjects who were randomized. Baseline IGA Severe population: All randomized subjects who had IGA=4 at baseline.


Arm/Group Title		CD0271 0.3% /CD1579 2.5% Gel	CD0271 0.1% / CD1579 2.5%	Topical Gel Vehicle
Arm/Group Description:		Active arm ...	Comparator arm ...	Placebo arm
Arm/Group Description:		Active arm CD0271 0.3% / CD1579 2.5%	Comparator arm CD0271 0.1% / CD1579 2.5%	Placebo arm Topical Gel Vehicle
Overall Number of Participants Analyzed		217	217	69
Measure Type: Number Unit of Measure: percentage of participants
All subjects (MI: Multiple Imputation)	Number Analyzed	217 participants	217 participants	69 participants
All subjects (MI: Multiple Imputation)		33.7	27.3	11.0
Baseline IGA=Severe (4) (MI: Multiple Imputation)	Number Analyzed	106 participants	112 participants	34 participants
Baseline IGA=Severe (4) (MI: Multiple Imputation)		31.9	20.5	11.8

2.Primary Outcome


Title	Changes From Baseline in Inflammatory Lesion Counts
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Baseline - Week12

Outcome Measure Data

Analysis Population Description

ITT Population, Multiple imputation


Arm/Group Title		CD0271 0.3% /CD1579 2.5% Gel	CD0271 0.1% / CD1579 2.5%	Topical Gel Vehicle
Arm/Group Description:		Active arm ...	Comparator arm ...	Placebo arm
Arm/Group Description:		Active arm CD0271 0.3% / CD1579 2.5%	Comparator arm CD0271 0.1% / CD1579 2.5%	Placebo arm Topical Gel Vehicle
Overall Number of Participants Analyzed		217	217	69
Least Squares Mean (Standard Error) Unit of Measure: Lesions
All Subjects	Number Analyzed	217 participants	217 participants	69 participants
All Subjects		-27.04 (0.846)	-26.72 (0.822)	-14.40 (1.460)
Baseline IGA = Severe (4)	Number Analyzed	106 participants	112 participants	34 participants
Baseline IGA = Severe (4)		-35.17 (1.407)	-31.92 (1.320)	-15.46 (2.297)

3.Primary Outcome


Title	Changes From Baseline in Non-Inflammatory Lesion Counts
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Baseline - Week 12

Outcome Measure Data

Analysis Population Description

ITT Population, Multiple Imputation


Arm/Group Title		CD0271 0.3% /CD1579 2.5% Gel	CD0271 0.1% / CD1579 2.5%	Topical Gel Vehicle
Arm/Group Description:		Active arm ...	Comparator arm ...	Placebo arm
Arm/Group Description:		Active arm CD0271 0.3% / CD1579 2.5%	Comparator arm CD0271 0.1% / CD1579 2.5%	Placebo arm Topical Gel Vehicle
Overall Number of Participants Analyzed		217	217	69
Least Squares Mean (Standard Error) Unit of Measure: lesions
All Subjects	Number Analyzed	217 participants	217 participants	69 participants
All Subjects		-40.18 (1.332)	-39.00 (1.277)	-18.47 (2.270)
Baseline IGA = Severe (4)	Number Analyzed	106 participants	112 participants	34 participants
Baseline IGA = Severe (4)		-45.61 (2.058)	-43.10 (1.847)	-17.25 (3.337)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	CD0271 0.3% /CD1579 2.5% Gel		CD0271 0.1% / CD1579 2.5%		Topical Gel Vehicle
Arm/Group Description	Active arm ...		Comparator arm ...		Placebo arm
Arm/Group Description	Active arm CD0271 0.3% / CD1579 2.5%		Comparator arm CD0271 0.1% / CD1579 2.5%		Placebo arm Topical Gel Vehicle
All-Cause Mortality
	CD0271 0.3% /CD1579 2.5% Gel		CD0271 0.1% / CD1579 2.5%		Topical Gel Vehicle
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--		--/--
Serious Adverse Events Serious Adverse Events
	CD0271 0.3% /CD1579 2.5% Gel		CD0271 0.1% / CD1579 2.5%		Topical Gel Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/217 (0.00%)		1/217 (0.46%)		0/69 (0.00%)
Psychiatric disorders
Generalized Anxiety Disorder	0/217 (0.00%)	0	1/217 (0.46%)	1	0/69 (0.00%)	0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	1%
	CD0271 0.3% /CD1579 2.5% Gel		CD0271 0.1% / CD1579 2.5%		Topical Gel Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	34/217 (15.67%)		23/217 (10.60%)		13/69 (18.84%)
Ear and labyrinth disorders
Motion sickness	0/217 (0.00%)		0/217 (0.00%)		1/69 (1.45%)
General disorders
Fatigue	0/217 (0.00%)		1/217 (0.46%)		1/69 (1.45%)
Pyrexia	0/217 (0.00%)		0/217 (0.00%)		1/69 (1.45%)
Infections and infestations
Nasopharyngitis	14/217 (6.45%)		11/217 (5.07%)		1/69 (1.45%)
Upper respiratory tract infection	1/217 (0.46%)		5/217 (2.30%)		4/69 (5.80%)
Infleunza	2/217 (0.92%)		2/217 (0.92%)		1/69 (1.45%)
Gastroenteritis	3/217 (1.38%)		1/217 (0.46%)		0/69 (0.00%)
Ear infection	0/217 (0.00%)		0/217 (0.00%)		1/69 (1.45%)
Pharyngitis	0/217 (0.00%)		0/217 (0.00%)		1/69 (1.45%)
Metabolism and nutrition disorders
Hypokalemia	0/217 (0.00%)		0/217 (0.00%)		1/69 (1.45%)
Nervous system disorders
Headache	3/217 (1.38%)		2/217 (0.92%)		1/69 (1.45%)
Dizziness	0/217 (0.00%)		0/217 (0.00%)		1/69 (1.45%)
Rhinitis seasonal	0/217 (0.00%)		0/217 (0.00%)		1/69 (1.45%)
Respiratory, thoracic and mediastinal disorders
Cough	1/217 (0.46%)		1/217 (0.46%)		1/69 (1.45%)
Skin and subcutaneous tissue disorders
Skin irritation	9/217 (4.15%)		1/217 (0.46%)		0/69 (0.00%)
Dermatitis allergic	1/217 (0.46%)		3/217 (1.38%)		0/69 (0.00%)
Eczema	3/217 (1.38%)		0/217 (0.00%)		0/69 (0.00%)
Rash	1/217 (0.46%)		0/217 (0.00%)		1/69 (1.45%)
Urticaria	1/217 (0.46%)		0/217 (0.00%)		1/69 (1.45%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Galderma CPM
Organization:	Galderma R&D
Phone:	00 33 4 93 95 70 70
EMail:	clinicaltrials@galderma.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Stein Gold L, Werschler WP, Mohawk J. Adapalene/Benzoyl Peroxide Gel 0.3%/2.5%: Effective Acne Therapy Regardless of Age or Gender. J Drugs Dermatol. 2017 Jun 1;16(6):582-589.

Alexis AF, Cook-Bolden FE, York JP. Adapalene/Benzoyl Peroxide Gel 0.3%/2.5%: A Safe and Effective Acne Therapy in All Skin Phototypes. J Drugs Dermatol. 2017 Jun 1;16(6):574-581.

Stein Gold L, Weiss J, Rueda MJ, Liu H, Tanghetti E. Moderate and Severe Inflammatory Acne Vulgaris Effectively Treated with Single-Agent Therapy by a New Fixed-Dose Combination Adapalene 0.3 %/Benzoyl Peroxide 2.5 % Gel: A Randomized, Double-Blind, Parallel-Group, Controlled Study. Am J Clin Dermatol. 2016 Jun;17(3):293-303. doi: 10.1007/s40257-016-0178-4.

Layout table for additonal information

Responsible Party:	Galderma R&D
ClinicalTrials.gov Identifier:	NCT01880320
Other Study ID Numbers:	RD.06.SPR.18240
First Submitted:	June 14, 2013
First Posted:	June 18, 2013
Results First Submitted:	March 7, 2016
Results First Posted:	September 9, 2016
Last Update Posted:	June 28, 2018

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