A Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris

• Sponsor: Galderma R&D (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00421993
• Collaborator: (none)
• Enrollment: 1,670
• Locations: 62
• Arms: 4
• Duration (Months): 14
• Patients Per Site: 26.9
• Patients Per Site Per Month: 1.9

Study Details

Study Description

Brief Summary

This is a multi-center, randomized, double-blind, parallel group study with 12 weeks of treatment of acne vulgaris. Efficacy and safety evaluations will be performed at Screening (safety only), Baseline and Weeks 1, 2, 4, 8 and 12. All Investigator's Global Assessment evaluators and lesion counters must be trained and approved by Galderma. The evaluator of a subject should remain the same during the study.

The primary objective is to demonstrate the superiority in efficacy and assess safety of Adapalene/Benzoyl Peroxide Topical Gel (Adapalene/Benzoyl Peroxide Gel) versus Adapalene Topical Gel, 0.1% (Adapalene Monad); Benzoyl Peroxide Topical Gel, 2.5% (Benzoyl Peroxide Monad) and Topical Gel Vehicle (Gel Vehicle) in the treatment of acne vulgaris for up to 12 weeks.

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris	Drug: Adapalene/Benzoyl Peroxide; Drug: Adapalene; Drug: Benzoyl Peroxide; Drug: Topical Gel Vehicle	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 1670 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 Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel Compared With Adapalene Topical Gel, 0.1%; Benzoyl Peroxide Topical Gel, 2.5% and Topical Gel Vehicle in Subjects With Acne Vulgaris
• Study Start Date: Oct 1, 2006
• Actual Primary Completion Date: Oct 1, 2007
• Actual Study Completion Date: Dec 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Adapalene/Benzoyl Peroxide Topical Gel	Drug: Adapalene/Benzoyl Peroxide; Topical Gel, One application daily in the evening for 12 weeks
Active Comparator: 2 Adapalene Topical Gel	Drug: Adapalene; Topical Gel,One application daily in the evening for 12 weeks
Active Comparator: 3 Benzoyl Peroxide Topical Gel	Drug: Benzoyl Peroxide; Topical Gel, one application daily in the evening for 12 weeks
Placebo Comparator: 4 Topical Gel Vehicle	Drug: Topical Gel Vehicle; Topical Gel Vehicle,one application daily in the evening for 12 weeks

Outcome Measures

Primary Outcome Measures

1. Success Rate on the Investigator's Global Assessment [at week 12]

   Percentage of subjects rated "Clear" and "Almost Clear" on 5-point scale (0=clear; 4=severe)

2. Changes in Inflammatory Lesion Counts [from Baseline to week 12]

   Changes in Inflammatory Lesion Counts equals Week 12 Inflammatory Lesion Counts minus Baseline Inflammatory Lesion Counts

3. Changes in Noninflammatory Lesion Counts [from Baseline to week 12]

   Change in Noninflammatory Lesion Counts equals Week 12 Noninflammatory Lesion Count minus Baseline Noninflammatory Lesion Count

Secondary Outcome Measures

1. Percent Change in Inflammatory Lesion Counts [at week 12]

   Percent Changes in Inflammatory Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100

2. Percent Change in Noniflammatory Lesion Counts [at week 12]

   Percent Changes in Noninflammatory Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100

3. Percent Change in Total Lesion Counts [at week 12]

   Percent Changes in Total Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• A clinical diagnosis of acne vulgaris with facial involvement.

• A minimum of 20 but not more than 50 Inflammatory lesions

• A minimum of 30 but not more than 100 Noninflammatory lesions

• A score of 3 (Moderate) on the Investigator's Global Assessment Scale.

Exclusion Criteria:

• More than one acne nodule or any acne cyst.

• Acne conglobata, acne fulminans, secondary acne, or severe acne.

• Known previous participation in an Adapalene/Benzoyl Peroxide Topical Gel Trial.

• Underlying diseases that require the use of interfering topical or systemic therapy.

• Use of prohibited medications prior to the study unless appropriate washout period is documented

• Use of hormonal contraceptives solely for control of acne

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical Affliated Research Center	Huntsville	Alabama	United States	35801
2	Dermatology Research of Arkansas	Little Rock	Arkansas	United States	72205
3	Associates in research, Inc.	Fresno	California	United States	93720
4	University of California, Irvine	Irvine	California	United States	92697-1385
5	Dermatology Research Associates	Los Angeles	California	United States	90045
6	Marcia J. Glenn, MD and Associates, Dermatology & Laser center, Inc	Marina Del Rey	California	United States	90292
7	Affiliated Research Institute	San Diego	California	United States	92108
8	University at San Francisco Medical Center	San Francisco	California	United States	94143
9	Radiant Research	Santa Rosa	California	United States	95405
10	Dr Weintraub James	Simi Valley	California	United States	93065
11	The George Washington University Medical Center	Washington	District of Columbia	United States	20037
12	Visions Clinical Research	West Palm Beach	Florida	United States	33406
13	Atlanta Dermatology and Vein Research Center	Alpharetta	Georgia	United States	30005
14	SKINQRI	Lincolnshire	Illinois	United States	60069
15	Welborn Clinic	Evansville	Indiana	United States	47713
16	Dawes Fretzin Clinical Research Group, LLC	Indianapolis	Indiana	United States	46256
17	Dolby Research, LLC	Baton Rouge	Louisiana	United States	70809
18	Hamzavi Dermatology	Port Huron	Michigan	United States	48060
19	Somerset Skin Clinic	Troy	Michigan	United States	48084
20	James Del Rosso, DO - Office of Dr. James Del Russo	Henderson	Nevada	United States	89052
21	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756
22	Skin Specialty Group	New York	New York	United States	10021
23	Derm Research Center of NY, Inc.	Stony Brook	New York	United States	11790-2598
24	Zoe Draelos	High Point	North Carolina	United States	27262
25	OU Health Sciences Center - Dept. of Dermatology	Oklahoma City	Oklahoma	United States	73104
26	Allergy, Asthma and Dermatology Research Center, LLC	Lake Oswego	Oregon	United States	97035
27	Radiant Research	Anderson	South Carolina	United States	29621
28	Dermatology Associates of Knoxville	Knoxville	Tennessee	United States	37934
29	Arlington Center for Dermatology	Arlington	Texas	United States	76011
30	UTSW Medical Center at Dallas	Dallas	Texas	United States	75390-9190
31	University of Texas Medical Branch at Galveston	Galveston	Texas	United States	77555
32	Tanner Clinic	Layton	Utah	United States	84041
33	Fletcher Allen Health Care	Burlington	Vermont	United States	05401
34	The Dermatology Centre	Calgary	Alberta	Canada	T2S 3B3
35	Stratica Medical	Edmonton	Alberta	Canada	T5K 1X3
36	Guildford Dermatology Specialists	Surrey	British Columbia	Canada	BC V3R 6A7
37	Derm Research @ 888 Inc.	Vancouver	British Columbia	Canada	V5Z 3Y1
38	Winnipeg Clinic	Winnipeg	Manitoba	Canada	R3C 0N2
39	Dermadvances Research	Winnipeg	Manitoba	Canada	R3C 1R4
40	Nexus clinical research	St. John's	Newfoundland and Labrador	Canada	A1B 3E1
41	NewLab Clinical Research	St. John's	Newfoundland and Labrador	Canada	A1B 4S8
42	Ultranova Skin care	Barrie	Ontario	Canada	L4M 6L2
43	Lynderm Research inc.	Markham	Ontario	Canada	L3P 1A8
44	North Bay Dermatology Centre	North Bay	Ontario	Canada	P1B 3Z7
45	XLR8 Medical Research Inc.	Windsor	Ontario	Canada	N8W 1E6
46	Innovaderm Research Laval Inc.	Laval	Quebec	Canada	H7S 2C6
47	Innovaderm Research Inc	Montreal	Quebec	Canada	H2K 4L5
48	Siena Medical Research	Montreal	Quebec	Canada	H3G1C6
49	Licca Clinical Research Institute	Augsburg		Germany	86179
50	Henrik Pres	Berlin		Germany	10435
51	Meike Schroeder	Berlin		Germany	14169
52	Beatrice Gerlach	Dresden		Germany	01097
53	Kloverkorn, Windfried	Gilching		Germany	82205
54	Otto-Von-Guericke-Universitat Magdeburg	Magdeburg		Germany	39120
55	Michael Sebastian	Mahlow		Germany	15831
56	Thomas Dirschka	Wuppertal		Germany	42275
57	Outpatient Dermatology Department DUH	Budapest		Hungary	1036
58	Margit Simola	Budapest		Hungary	1084
59	Outpatient Dermatilogy Department XIX District	Budapest		Hungary	1195
60	Waldemar Placek	Bydgoszcz		Poland	85096
61	DERMED Specjalistyczne Gabinety Lekarskie	Lodz		Poland	90265
62	Wojceiech Silny	Poznan		Poland	60355

Sponsors and Collaborators

• Galderma R&D

Investigators

• Study Director: Michael Graeber, MD, Galderma R&D

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

• Leyden JJ. A review of the use of combination therapies for the treatment of acne vulgaris. J Am Acad Dermatol. 2003 Sep;49(3 Suppl):S200-10. Review.

• ClinicalTrials.gov Identifier: NCT00421993
• Other Study ID Numbers: RD.06.SPR.18088
• First Posted: Jan 15, 2007
• Last Update Posted: Feb 18, 2021
• Last Verified: Oct 1, 2009

• Keywords provided by , ,: Acne vulgaris; Adapalene; Benzoyl Peroxide
• Additional relevant MeSH terms: Acne Vulgaris; Adapalene; Adapalene, Benzoyl Peroxide Drug Combination; Benzoyl Peroxide

Study Results

Participant Flow

Recruitment Details	Recruitment period: First Subject Enrolled October 2006, Last Subject Enrolled July 2007. Types of locations: Dermatology Clinics, Dermatology Research Centers.
Pre-assignment Detail	The specified washout period up to Baseline for TOPICAL facial treatments was 1 week (light therapy/exfoliation/blackhead removal) or 2 weeks (anti-inflammatory drugs/salicylic acid/steroids/antibiotics/laser) and for SYSTEMIC medications was 2 weeks (anti-inflammatory drugs), 4 Weeks (steroids/antibiotics), or 6 months (anti-acne/contraceptives).

Arm/Group Title	Adapalene/Benzoyl Peroxide Gel	Adapalene Gel	Benzoyl Peroxide Gel	Gel Vehicle
Arm/Group Description	Adapalene/Benzoyl Peroxide Topical Gel	Adapalene Topical Gel	Benzoyl Peroxide Topical Gel	Topical Gel Vehicle
Period Title: Overall Study
STARTED	419	418	415	418
COMPLETED	366	369	363	361
NOT COMPLETED	53	49	52	57

Baseline Characteristics

Arm/Group Title	Adapalene/Benzoyl Peroxide Gel	Adapalene Gel	Benzoyl Peroxide Gel	Gel Vehicle	Total
Arm/Group Description	Adapalene/Benzoyl Peroxide Topical Gel	Adapalene Topical Gel	Benzoyl Peroxide Topical Gel	Topical Gel Vehicle	Total of all reporting groups
Overall Participants	419	418	415	418	1670
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	19.5 (6.7)	18.5 (6.3)	18.9 (6.96)	19.2 (7.23)	19 (6.81)
Age, Customized (participants) [Number]
12-17 years	233 55.6%	241 57.7%	244 58.8%	243 58.1%	961 57.5%
Between 18 and 64 years	186 44.4%	177 42.3%	171 41.2%	175 41.9%	709 42.5%
>=65 years	0 0%	0 0%	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	236 56.3%	229 54.8%	230 55.4%	244 58.4%	939 56.2%
Male	183 43.7%	189 45.2%	185 44.6%	174 41.6%	731 43.8%
Region of Enrollment (participants) [Number]
United States	185 44.2%	185 44.3%	179 43.1%	185 44.3%	734 44%
Canada	102 24.3%	100 23.9%	100 24.1%	101 24.2%	403 24.1%
Europe	132 31.5%	133 31.8%	136 32.8%	132 31.6%	533 31.9%

Outcome Measures

1. Primary Outcome

Title	Success Rate on the Investigator's Global Assessment
Description	Percentage of subjects rated "Clear" and "Almost Clear" on 5-point scale (0=clear; 4=severe)
Time Frame	at week 12

Outcome Measure Data

Analysis Population Description

Intention to treat (ITT), last observation carried forward (LOCF).

Arm/Group Title	Adapalene/Benzoyl Peroxide Gel	Adapalene Gel	Benzoyl Peroxide Gel	Gel Vehicle
Arm/Group Description	Adapalene/Benzoyl Peroxide Topical Gel	Adapalene Topical Gel	Benzoyl Peroxide Topical Gel	Topical Gel Vehicle
Measure Participants	419	418	415	418
Number [Percentage of participants]	37.9 9%	21.8 5.2%	26.7 6.4%	17.9 4.3%

2. Primary Outcome

Title	Changes in Inflammatory Lesion Counts
Description	Changes in Inflammatory Lesion Counts equals Week 12 Inflammatory Lesion Counts minus Baseline Inflammatory Lesion Counts
Time Frame	from Baseline to week 12

Outcome Measure Data

Analysis Population Description

ITT, LOCF

Arm/Group Title	Adapalene/Benzoyl Peroxide Gel	Adapalene Gel	Benzoyl Peroxide Gel	Gel Vehicle
Arm/Group Description	Adapalene/Benzoyl Peroxide Topical Gel	Adapalene Topical Gel	Benzoyl Peroxide Topical Gel	Topical Gel Vehicle
Measure Participants	419	418	415	418
Median (Full Range) [Lesion count]	-18	-15	-16	-12

3. Primary Outcome

Title	Changes in Noninflammatory Lesion Counts
Description	Change in Noninflammatory Lesion Counts equals Week 12 Noninflammatory Lesion Count minus Baseline Noninflammatory Lesion Count
Time Frame	from Baseline to week 12

Outcome Measure Data

Analysis Population Description

ITT, LOCF

Arm/Group Title	Adapalene/Benzoyl Peroxide Gel	Adapalene Gel	Benzoyl Peroxide Gel	Gel Vehicle
Arm/Group Description	Adapalene/Benzoyl Peroxide Topical Gel	Adapalene Topical Gel	Benzoyl Peroxide Topical Gel	Topical Gel Vehicle
Measure Participants	419	418	415	418
Median (Full Range) [Lesion count]	-28	-24	-23	-18

4. Secondary Outcome

Title	Percent Change in Inflammatory Lesion Counts
Description	Percent Changes in Inflammatory Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100
Time Frame	at week 12

Outcome Measure Data

Analysis Population Description

ITT, LOCF

Arm/Group Title	Adapalene/Benzoyl Peroxide Gel	Adapalene Gel	Benzoyl Peroxide Gel	Gel Vehicle
Arm/Group Description	Adapalene/Benzoyl Peroxide Topical Gel	Adapalene Topical Gel	Benzoyl Peroxide Topical Gel	Topical Gel Vehicle
Measure Participants	419	418	415	418
Mean (Standard Deviation) [Percent change]	-61.7 (33.9)	-50.1 (39.4)	-52.2 (39.4)	-40.8 (41.1)

5. Secondary Outcome

Title	Percent Change in Noniflammatory Lesion Counts
Description	Percent Changes in Noninflammatory Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100
Time Frame	at week 12

Outcome Measure Data

Analysis Population Description

ITT, LOCF

Arm/Group Title	Adapalene/Benzoyl Peroxide Gel	Adapalene Gel	Benzoyl Peroxide Gel	Gel Vehicle
Arm/Group Description	Adapalene/Benzoyl Peroxide Topical Gel	Adapalene Topical Gel	Benzoyl Peroxide Topical Gel	Topical Gel Vehicle
Measure Participants	419	418	415	418
Mean (Standard Deviation) [Percent change]	-55.6 (35.3)	-46.0 (33.7)	-44.1 (37.3)	-32.3 (39.5)

6. Secondary Outcome

Title	Percent Change in Total Lesion Counts
Description	Percent Changes in Total Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100
Time Frame	at week 12

Outcome Measure Data

Analysis Population Description

ITT, LOCF

Arm/Group Title	Adapalene/Benzoyl Peroxide Gel	Adapalene Gel	Benzoyl Peroxide Gel	Gel Vehicle
Arm/Group Description	Adapalene/Benzoyl Peroxide Topical Gel	Adapalene Topical Gel	Benzoyl Peroxide Topical Gel	Topical Gel Vehicle
Measure Participants	419	418	415	418
Mean (Standard Deviation) [Percent change]	-57.7 (31.9)	-47.5 (31.3)	-47.2 (32.7)	-35.2 (36)

Adverse Events

Arm/Group Title	Adapalene/Benzoyl Peroxide Gel		Adapalene Gel		Benzoyl Peroxide Gel		Gel Vehicle
Arm/Group Description	Adapalene/Benzoyl Peroxide Topical Gel		Adapalene Topical Gel		Benzoyl Peroxide Topical Gel		Topical Gel Vehicle
All Cause Mortality
	Adapalene/Benzoyl Peroxide Gel		Adapalene Gel		Benzoyl Peroxide Gel		Gel Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Adapalene/Benzoyl Peroxide Gel		Adapalene Gel		Benzoyl Peroxide Gel		Gel Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/419 (0.7%)		1/418 (0.2%)		1/415 (0.2%)		2/418 (0.5%)
Infections and infestations
Furuncle	1/419 (0.2%)	1	0/418 (0%)	0	0/415 (0%)	0	0/418 (0%)	0
Appendicitis	1/419 (0.2%)	1	0/418 (0%)	0	0/415 (0%)	0	0/418 (0%)	0
Abscess limb	0/419 (0%)	0	0/418 (0%)	0	0/415 (0%)	0	1/418 (0.2%)	1
Injury, poisoning and procedural complications
Cervical vertebral fracture	0/419 (0%)	0	0/418 (0%)	0	0/415 (0%)	0	1/418 (0.2%)	1
Musculoskeletal and connective tissue disorders
Scoliosis	1/419 (0.2%)	1	0/418 (0%)	0	0/415 (0%)	0	0/418 (0%)	0
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous	0/419 (0%)	0	0/418 (0%)	0	1/415 (0.2%)	1	0/418 (0%)	0
Psychiatric disorders
Schizoaffective disorder	0/419 (0%)	0	1/418 (0.2%)	1	0/415 (0%)	0	0/418 (0%)	0
Other (Not Including Serious) Adverse Events
	Adapalene/Benzoyl Peroxide Gel		Adapalene Gel		Benzoyl Peroxide Gel		Gel Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	90/419 (21.5%)		60/418 (14.4%)		35/415 (8.4%)		22/418 (5.3%)
Skin and subcutaneous tissue disorders
Dry Skin	90/419 (21.5%)	93	60/418 (14.4%)	61	35/415 (8.4%)	37	22/418 (5.3%)	22

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Following the expiration of twenty-four (24) months after the completion of the Study, Investigator shall have the right to publish the results of the Study; provided, however that Sponsor shall have the right to review any proposed publication generated from the Study prior to publication or presentation. The Sponsor shall have the absolute right to refuse the publication altogether, to delay it or to amend its contents as it deems fit.