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

This study has been completed.

Study NCT00421993 Information provided by Galderma

First Received: January 11, 2007 Last Updated: October 19, 2009 History of Changes

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
Condition:	Acne Vulgaris
Interventions:	Drug: Adapalene/Benzoyl Peroxide Drug: Adapalene Drug: Benzoyl Peroxide Drug: Topical Gel Vehicle

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment period: First Subject Enrolled October 2006, Last Subject Enrolled July 2007. Types of locations: Dermatology Clinics, Dermatology Research Centers.

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

Recruitment period: First Subject Enrolled October 2006, Last Subject Enrolled July 2007.

Types of locations: Dermatology Clinics, Dermatology Research Centers.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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).

Reporting Groups

	Description
Adapalene/Benzoyl Peroxide Gel	Adapalene/Benzoyl Peroxide Topical Gel
Adapalene Gel	Adapalene Topical Gel
Benzoyl Peroxide Gel	Benzoyl Peroxide Topical Gel
Gel Vehicle	Topical Gel Vehicle

Participant Flow: Overall Study

	Adapalene/Benzoyl Peroxide Gel	Adapalene Gel	Benzoyl Peroxide Gel	Gel Vehicle
STARTED	419	418	415	418
COMPLETED	366	369	363	361
NOT COMPLETED	53	49	52	57
Withdrawal by Subject	22	23	23	24
Lost to Follow-up	18	19	22	20
Adverse Event	11	1	6	4
Protocol Violation	2	2	0	1
Lack of Efficacy	0	3	0	5
Pregnancy	0	1	1	2
Subject transportation issues	0	0	0	1

Baseline Characteristics

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Reporting Groups

	Description
Adapalene/Benzoyl Peroxide Gel	Adapalene/Benzoyl Peroxide Topical Gel
Adapalene Gel	Adapalene Topical Gel
Benzoyl Peroxide Gel	Benzoyl Peroxide Topical Gel
Gel Vehicle	Topical Gel Vehicle

Baseline Measures

	Adapalene/Benzoyl Peroxide Gel	Adapalene Gel	Benzoyl Peroxide Gel	Gel Vehicle	Total
Number of Participants [units: participants]	419	418	415	418	1670
Age [units: years] Mean ± Standard Deviation	19.5 ± 6.7	18.5 ± 6.3	18.9 ± 6.96	19.2 ± 7.23	19 ± 6.81
Age, Customized [units: participants]
12-17 years	233	241	244	243	961
Between 18 and 64 years	186	177	171	175	709
>=65 years	0	0	0	0	0
Gender [units: participants]
Female	236	229	230	244	939
Male	183	189	185	174	731
Region of Enrollment [units: participants]
United States	185	185	179	185	734
Canada	102	100	100	101	403
Europe	132	133	136	132	533

Outcome Measures

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1. Primary:

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

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Measure Type	Primary
Measure Title	Success Rate on the Investigator's Global Assessment
Measure Description	Percentage of subjects rated “Clear” and “Almost Clear” on 5-point scale (0=clear; 4=severe)
Time Frame	at week 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to treat (ITT), last observation carried forward (LOCF).

Reporting Groups

	Description
Adapalene/Benzoyl Peroxide Gel	Adapalene/Benzoyl Peroxide Topical Gel
Adapalene Gel	Adapalene Topical Gel
Benzoyl Peroxide Gel	Benzoyl Peroxide Topical Gel
Gel Vehicle	Topical Gel Vehicle

Measured Values

	Adapalene/Benzoyl Peroxide Gel	Adapalene Gel	Benzoyl Peroxide Gel	Gel Vehicle
Number of Participants Analyzed [units: participants]	419	418	415	418
Success Rate on the Investigator's Global Assessment [units: Percentage of participants]	37.9	21.8	26.7	17.9

No statistical analysis provided for Success Rate on the Investigator's Global Assessment

2. Primary:

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

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3. Primary:

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

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4. Secondary:

Percent Change in Inflammatory Lesion Counts [ at week 12 ]

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5. Secondary:

Percent Change in Noniflammatory Lesion Counts [ at week 12 ]

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6. Secondary:

Percent Change in Total Lesion Counts [ at week 12 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

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

There IS 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.

The agreement is:

	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.
	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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Michael Graeber, MD
Organization: Galderma
phone: 609-860-8201
e-mail: michael.graeber@galderma.com

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.

Responsible Party:	Galderma ( Michael Graeber, MD, Head of US Development )
Study ID Numbers:	RD.06.SPR.18088
Study First Received:	January 11, 2007
Results First Received:	January 15, 2009
Last Updated:	October 19, 2009
ClinicalTrials.gov Identifier:	NCT00421993 History of Changes
Health Authority:	United States: Food and Drug Administration