Adapalene-BPO Gel Associated With Doxycycline Hyclate 100 mg in the Treatment of Severe Acne Vulgaris - Study Results

Adapalene-BPO Gel Associated With Doxycycline Hyclate 100 mg in the Treatment of Severe Acne Vulgaris (ACCESS I)

This study has been completed.

Study NCT00688064 Information provided by Galderma

First Received on May 28, 2008. Last Updated on March 31, 2010 History of Changes

Results First Received: February 23, 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:	Severe Acne Vulgaris
Interventions:	Drug: Adapalene BPO Gel associated with Doxycyline Hyclate Drug: Vehicle Gel associated with Doxycycline Hyclate

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: 18 AUG 2008 to 14 NOV 2008 in thirty-five centers (30 in the USA and 5 in Canada) public or private practices. Twenty-five 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 + Doxycycline	Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Doxycyline Hyclate 100 mg tablet.
Vehicle + Doxycycline	Vehicle Gel associated with Doxycycline Hyclate 100 mg tablet

Participant Flow: Overall Study

	Adapalene-BPO + Doxycycline	Vehicle + Doxycycline
STARTED	232	227
COMPLETED	211	201
NOT COMPLETED	21	26
Protocol Violation	0	1
Adverse Event	2	4
Withdrawal by Subject	7	7
Lost to Follow-up	10	10
Lack of Efficacy	0	1
Pregnancy	1	0
Any other reasons	1	3

Baseline Characteristics

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Reporting Groups

	Description
Adapalene-BPO + Doxycycline	Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Doxycyline Hyclate 100 mg tablet.
Vehicle + Doxycycline	Vehicle Gel associated with Doxycycline Hyclate 100 mg tablet

Baseline Measures

	Adapalene-BPO + Doxycycline	Vehicle + Doxycycline	Total
Number of Participants [units: participants]	232	227	459
Age [units: participants]
<=18 years	152	156	308
Between 18 and 65 years	80	71	151
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	18.6 ± 5.84	18.1 ± 4.92	18.4 ± 5.41
Gender [units: participants]
Female	108	97	205
Male	124	130	254
Region of Enrollment [units: participants]
United States	170	164	334
Puerto Rico	18	18	36
Canada	44	45	89

Outcome Measures

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1. Primary:

Percent Change From Baseline in Total Lesion Counts at Week 12. [ Time Frame: Week 12 ]

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2. Secondary:

Percent Change From Baseline in Inflammatory Lesion Counts at Week 12. [ Time Frame: Week 12 ]

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3. Secondary:

Percent Change From Baseline in Non-inflammatory Lesion Counts at Week 12 [ Time Frame: Week 12 ]

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4. Secondary:

Success Rate on the Investigator's Global Assessment [ Time Frame: Week 12 ]

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5. Secondary:

Percent of Subjects With Adverse Events [ Time Frame: Up 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: 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: Jean-Charles Dhuin, Clinical Project Manager
Organization: Galderma
phone: +33 4 92 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:	NCT00688064 History of Changes
Other Study ID Numbers:	RD.03.SPR.29074
Study First Received:	May 28, 2008
Results First Received:	February 23, 2010
Last Updated:	March 31, 2010
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board; Canada: Health Canada; Canada: Ethics Review Committee