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

This study has been completed.
Sponsor:
Information provided by:
Galderma
ClinicalTrials.gov Identifier:
NCT00688064
First received: May 28, 2008
Last updated: March 31, 2010
Last verified: March 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
No text entered.

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
Total Total of all reporting groups

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 ]
  Show Outcome Measure 1

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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Measure Type Secondary
Measure Title Percent Change From Baseline in Non-inflammatory Lesion Counts at Week 12
Measure Description No text entered.
Time Frame 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.
ITT, LOCF

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

Measured Values
    Adapalene-BPO + Doxycycline     Vehicle + Doxycycline  
Number of Participants Analyzed  
[units: participants]
 		  232     227  
Percent Change From Baseline in Non-inflammatory Lesion Counts at Week 12  
[units: % of change]
Median ( Full Range ) 		  -61  
  ( -100 to 81 )   		  -40  
  ( -98 to 149 )  

No statistical analysis provided for Percent Change From Baseline in Non-inflammatory Lesion Counts at Week 12



4.  Secondary:   Success Rate on the Investigator's Global Assessment   [ Time Frame: Week 12 ]
  Show Outcome Measure 4

5.  Secondary:   Percent of Subjects With Adverse Events   [ Time Frame: Up to 12 weeks ]
  Show Outcome Measure 5


  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:
unchecked 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.
unchecked 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.


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
No text entered.  


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