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

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ClinicalTrials.gov Identifier: NCT00688064
Recruitment Status : Completed
First Posted : June 2, 2008
Results First Posted : March 31, 2010
Last Update Posted : April 6, 2010
Sponsor:
Information provided by:
Galderma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, 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
Enrollment 459
Recruitment Details 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  
Arm/Group Title Adapalene-BPO + Doxycycline Vehicle + Doxycycline
Hide Arm/Group Description Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Doxycyline Hyclate 100 mg tablet. Vehicle Gel associated with Doxycycline Hyclate 100 mg tablet
Period Title: Overall Study
Started 232 227
Completed 211 201
Not Completed 21 26
Reason Not Completed
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
Arm/Group Title Adapalene-BPO + Doxycycline Vehicle + Doxycycline Total
Hide Arm/Group Description Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Doxycyline Hyclate 100 mg tablet. Vehicle Gel associated with Doxycycline Hyclate 100 mg tablet Total of all reporting groups
Overall Number of Baseline Participants 232 227 459
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 232 participants 227 participants 459 participants
<=18 years
152
  65.5%
156
  68.7%
308
  67.1%
Between 18 and 65 years
80
  34.5%
71
  31.3%
151
  32.9%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 232 participants 227 participants 459 participants
18.6  (5.84) 18.1  (4.92) 18.4  (5.41)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 232 participants 227 participants 459 participants
Female
108
  46.6%
97
  42.7%
205
  44.7%
Male
124
  53.4%
130
  57.3%
254
  55.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 232 participants 227 participants 459 participants
United States 170 164 334
Puerto Rico 18 18 36
Canada 44 45 89
1.Primary Outcome
Title Percent Change From Baseline in Total Lesion Counts at Week 12.
Hide Description [Not Specified]
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT, LOCF
Arm/Group Title Adapalene-BPO + Doxycycline Vehicle + Doxycycline
Hide Arm/Group Description:
Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Doxycyline Hyclate 100 mg tablet.
Vehicle Gel associated with Doxycycline Hyclate 100 mg tablet
Overall Number of Participants Analyzed 232 227
Median (Full Range)
Unit of Measure: % of change
-64
(-100 to 34)
-41
(-92 to 64)
2.Secondary Outcome
Title Percent Change From Baseline in Inflammatory Lesion Counts at Week 12.
Hide Description [Not Specified]
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT, LOCF
Arm/Group Title Adapalene-BPO + Doxycycline Vehicle + Doxycycline
Hide Arm/Group Description:
Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Doxycyline Hyclate 100 mg tablet.
Vehicle Gel associated with Doxycycline Hyclate 100 mg tablet
Overall Number of Participants Analyzed 232 227
Median (Full Range)
Unit of Measure: % of change
-72
(-100 to 59)
-48
(-93 to 79)
3.Secondary Outcome
Title Percent Change From Baseline in Non-inflammatory Lesion Counts at Week 12
Hide Description [Not Specified]
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT, LOCF
Arm/Group Title Adapalene-BPO + Doxycycline Vehicle + Doxycycline
Hide Arm/Group Description:
Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Doxycyline Hyclate 100 mg tablet.
Vehicle Gel associated with Doxycycline Hyclate 100 mg tablet
Overall Number of Participants Analyzed 232 227
Median (Full Range)
Unit of Measure: % of change
-61
(-100 to 81)
-40
(-98 to 149)
4.Secondary Outcome
Title Success Rate on the Investigator's Global Assessment
Hide Description Percentage of subjects graded "Clear" or "Almost Clear" on 6-point IGA scale(0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe and 5=very severe)at week 12
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT, LOCF
Arm/Group Title Adapalene-BPO + Doxycycline Vehicle + Doxycycline
Hide Arm/Group Description:
Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Doxycyline Hyclate 100 mg tablet.
Vehicle Gel associated with Doxycycline Hyclate 100 mg tablet
Overall Number of Participants Analyzed 232 227
Measure Type: Number
Unit of Measure: % of subjects
31.5 8.4
5.Secondary Outcome
Title Percent of Subjects With Adverse Events
Hide Description Percent of subjects with Adverse Events all along the study (up to 12 weeks follow-up period)
Time Frame Up to 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Adapalene-BPO + Doxycycline Vehicle + Doxycycline
Hide Arm/Group Description:
Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Doxycyline Hyclate 100 mg tablet.
Vehicle Gel associated with Doxycycline Hyclate 100 mg tablet
Overall Number of Participants Analyzed 232 227
Measure Type: Number
Unit of Measure: % of subjects
26.3 26.9
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Adapalene-BPO + Doxycycline Vehicle + Doxycycline
Hide Arm/Group Description Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Doxycyline Hyclate 100 mg tablet. Vehicle Gel associated with Doxycycline Hyclate 100 mg tablet
All-Cause Mortality
Adapalene-BPO + Doxycycline Vehicle + Doxycycline
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Adapalene-BPO + Doxycycline Vehicle + Doxycycline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/232 (0.00%)      0/227 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Adapalene-BPO + Doxycycline Vehicle + Doxycycline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   43/232 (18.53%)      48/227 (21.15%)    
Gastrointestinal disorders     
dyspepsia *  2/232 (0.86%)  2 5/227 (2.20%)  5
nausea *  9/232 (3.88%)  9 12/227 (5.29%)  14
vomiting *  9/232 (3.88%)  10 10/227 (4.41%)  12
Infections and infestations     
gastroenteritis viral *  5/232 (2.16%)  5 2/227 (0.88%)  2
nasopharyngitis *  10/232 (4.31%)  10 13/227 (5.73%)  14
upper respiratory tract infection *  8/232 (3.45%)  8 6/227 (2.64%)  6
*
Indicates events were collected by non-systematic assessment
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.
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.
Results Point of Contact
Name/Title: Jean-Charles Dhuin, Clinical Project Manager
Organization: Galderma
Phone: +33 4 92 95 29 21
Responsible Party: Jean-Charles DHUIN Clinical Trial Manager, Galderma
ClinicalTrials.gov Identifier: NCT00688064     History of Changes
Other Study ID Numbers: RD.03.SPR.29074
First Submitted: May 28, 2008
First Posted: June 2, 2008
Results First Submitted: February 23, 2010
Results First Posted: March 31, 2010
Last Update Posted: April 6, 2010