Adapalene-Benzoy Peroxide (BPO) Gel in the Treatment of Acne Vulgaris as a 6-month Maintenance (ACCESS II)

This study has been completed.

Sponsor:

Information provided by:

Galderma

ClinicalTrials.gov Identifier:

NCT00687908

First received: May 28, 2008

Last updated: September 30, 2010

Last verified: September 2010

History of Changes

Results First Received: July 16, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Acne
Interventions:	Drug: Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel Drug: Vehicle Gel

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: 12 NOV 2008 to 09 FEB 2009 in thirty-four centers (29 in the USA and 5 in Canada) public or private practices. Twenty-four USA centers and four Candadian centers used a central IRB, and the others used a local IRB.

Pre-Assignment Details

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

	Description
Adapalene-BPO	Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
Vehicle	Vehicle Gel

Participant Flow: Overall Study

	Adapalene-BPO	Vehicle
STARTED	123	120
COMPLETED	105	78
NOT COMPLETED	18	42

Baseline Characteristics

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Reporting Groups

	Description
Adapalene-BPO	Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
Vehicle	Vehicle Gel
Total	Total of all reporting groups

Baseline Measures

	Adapalene-BPO	Vehicle	Total
Number of Participants [units: participants]	123	120	243
Age [units: participants]
<=18 years	76	84	160
Between 18 and 65 years	47	36	83
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	19.1 ± 5.89	18.2 ± 5.23	18.6 ± 5.58
Gender [units: participants]
Female	58	53	111
Male	65	67	132
Region of Enrollment [units: participants]
United States	84	79	163
Puerto Rico	13	13	26
Canada	26	28	54

Outcome Measures

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1. Primary:

Maintenance Success for Total Lesions at Week 24 [ Time Frame: Week 24 ]

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2. Secondary:

Maintenance Success for Inflamatory Lesions at Week 24 [ Time Frame: Week 24 ]

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3. Secondary:

Maintenance Success for Non-inflammatory Lesions at Week 24 [ Time Frame: Week 24 ]

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4. Secondary:

Investigator Global Assessment (IGA) Maintenance Success at Week 24 [ Time Frame: Baseline, Week 24 ]

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5. Secondary:

Percent of Subjects With Adverse Events [ Time Frame: Up to 24 weeks ]

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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: Any intent of the investigator to publish or disclose in any way the information requires the sponsor's prior written approval. The investigator shall provide their draft of such publication to sponsor for review and approval at least 2 months prior to the date of the intended publication. Sponsor shall have the absolute right to determine whether information may be published by the investigator.

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: Clinical Project Manager
Organization: Galderma
phone: +33 492 95 29 21
e-mail: jean-charles.dhuin@galderma.com

No publications provided

Responsible Party:	Jean-Charles DHUIN Clinical Trial Manager, Galderma
ClinicalTrials.gov Identifier:	NCT00687908 History of Changes
Other Study ID Numbers:	RD.03.SPR.29075
Study First Received:	May 28, 2008
Results First Received:	July 16, 2010
Last Updated:	September 30, 2010
Health Authority:	United States: Food and Drug Administration United States: Institutional Review Board Canada: Health Canada Canada: Ethics Review Committee

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