Clinical Study to Test the Efficacy and Safety of Adapalene, 0.1%

This study has been completed.

Study NCT00599521 Information provided by Galderma

First Received on January 11, 2008. Last Updated on March 21, 2011 History of Changes

Results First Received: April 16, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Acne Vulgaris
Interventions:	Drug: Adapalene lotion 0.1% Drug: Adapalene Lotion 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
Multi center study recruitment period: First subject enrolled Nov 6, 2007; last subject completed Nov 14, 2008

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Washout requirements: 2 weeks for systemic anti-inflammatory drugs, 4 weeks for oral antibiotics, 2 months for inhaled/nasal steroids and 6 months for hormonal contraceptives/therapies.

Reporting Groups

	Description
Adapalene Lotion 0.1%	once a day for 12 weeks
Adapalene Lotion Vehicle 0%	once a day for 12 weeks

Participant Flow: Overall Study

	Adapalene Lotion 0.1%	Adapalene Lotion Vehicle 0%
STARTED	535	531
COMPLETED	475	462
NOT COMPLETED	60	69
Lack of Efficacy	4	8
Adverse Event	4	1
Withdrawal by Subject	28	34
Protocol Violation	1	1
Lost to Follow-up	23	23
Pregnancy	0	2

Baseline Characteristics

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Reporting Groups

	Description
Adapalene Lotion 0.1%	once a day for 12 weeks
Adapalene Lotion Vehicle 0%	once a day for 12 weeks

Baseline Measures

	Adapalene Lotion 0.1%	Adapalene Lotion Vehicle 0%	Total
Number of Participants [units: participants]	535	531	1066
Age [units: participants]
<=18 years	338	336	674
Between 18 and 65 years	197	195	392
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	19.1 ± 6.8	19.2 ± 7.3	19.15 ± 7.05
Gender [units: participants]
Female	300	272	572
Male	235	259	494
Region of Enrollment [units: participants]
United States	487	484	971
Canada	48	47	95

Outcome Measures

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1. Primary:

Co-Primary Endpoint: Success Rate on Investigator's Global Assessment (IGA) From Baseline to Week 12 [ Time Frame: From Baseline to Week 12 ]

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2. Primary:

Co-Primary Endpoint: Absolute Change in Total Lesion Counts From Baseline to Week 12 [ Time Frame: Baseline to 12 weeks ]

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3. Primary:

Co-Primary Endpoint: Absolute Change in Inflammatory Lesion Count From Baseline to Week 12 [ Time Frame: Baseline to Week 12 ]

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4. Primary:

Co-Primary Endpoint: Absolute Change in NonInflammatory Lesion Counts From Baseline to Week 12 [ Time Frame: Baseline to Week 12 ]

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5. Secondary:

Mean Percent Change in Total Lesion Count From Baseline to Week 12 [ Time Frame: From Baseline to 12 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: disclosure restriction varies per institutional request/agreement

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/ Head of Global Clinical Project Management
Organization: Galderma
phone: 609-860-8201
e-mail: michael.graeber@galderma.com

No publications provided

Responsible Party:	Marie Ciardella Clinical Trials.gov Administrator, Galderma Laboratories, Inc
ClinicalTrials.gov Identifier:	NCT00599521 History of Changes
Other Study ID Numbers:	RD.06.SPR.18114, IND 076057
Study First Received:	January 11, 2008
Results First Received:	April 16, 2010
Last Updated:	March 21, 2011
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada