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

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ClinicalTrials.gov Identifier: NCT00599521
Recruitment Status : Completed
First Posted : January 23, 2008
Results First Posted : April 19, 2011
Last Update Posted : April 19, 2011
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 Acne Vulgaris
Interventions Drug: Adapalene lotion 0.1%
Drug: Adapalene Lotion Vehicle
Enrollment 1067
Recruitment Details Multi center study recruitment period: First subject enrolled Nov 6, 2007; last subject completed Nov 14, 2008
Pre-assignment Details 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.
Arm/Group Title Adapalene Lotion 0.1% Adapalene Lotion Vehicle 0%
Hide Arm/Group Description once a day for 12 weeks once a day for 12 weeks
Period Title: Overall Study
Started 535 531
Completed 475 462
Not Completed 60 69
Reason Not Completed
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
Arm/Group Title Adapalene Lotion 0.1% Adapalene Lotion Vehicle 0% Total
Hide Arm/Group Description once a day for 12 weeks once a day for 12 weeks Total of all reporting groups
Overall Number of Baseline Participants 535 531 1066
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 535 participants 531 participants 1066 participants
<=18 years
338
  63.2%
336
  63.3%
674
  63.2%
Between 18 and 65 years
197
  36.8%
195
  36.7%
392
  36.8%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 535 participants 531 participants 1066 participants
19.1  (6.8) 19.2  (7.3) 19.15  (7.05)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 535 participants 531 participants 1066 participants
Female
300
  56.1%
272
  51.2%
572
  53.7%
Male
235
  43.9%
259
  48.8%
494
  46.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 535 participants 531 participants 1066 participants
United States 487 484 971
Canada 48 47 95
1.Primary Outcome
Title Co-Primary Endpoint: Success Rate on Investigator's Global Assessment (IGA) From Baseline to Week 12
Hide Description Success defined as percentage of subjects who achieved at least a two-grade reduction in IGA scale (e.g from moderate to clear or almost clear)at week 12 from baseline, Last Observation Carried Forward, Intent to treat population. The IGA (Investigator Global Assessment) is defined as a 5 point scale (0 to 4). "0" = clear , "1"= almost clear, "2"= mild, "3"= moderate, "4"=severe.
Time Frame From Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adapalene Lotion 0.1% Adapalene Lotion Vehicle 0%
Hide Arm/Group Description:
once a day for 12 weeks
once a day for 12 weeks
Overall Number of Participants Analyzed 535 531
Measure Type: Number
Unit of Measure: Percentage of Participants
24.1 16.4
2.Primary Outcome
Title Co-Primary Endpoint: Absolute Change in Total Lesion Counts From Baseline to Week 12
Hide Description [Not Specified]
Time Frame Baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adapalene Lotion 0.1% Adapalene Lotion Vehicle 0%
Hide Arm/Group Description:
once a day for 12 weeks
once a day for 12 weeks
Overall Number of Participants Analyzed 535 531
Least Squares Mean (Standard Error)
Unit of Measure: Absolute Change in Total Lesion Count
32.5  (1.0) 23.3  (1.0)
3.Primary Outcome
Title Co-Primary Endpoint: Absolute Change in Inflammatory Lesion Count From Baseline to Week 12
Hide Description [Not Specified]
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adapalene Lotion 0.1% Adapalene Lotion Vehicle 0%
Hide Arm/Group Description:
once a day for 12 weeks
once a day for 12 weeks
Overall Number of Participants Analyzed 535 531
Least Squares Mean (Standard Error)
Unit of Measure: Absolute Change in Infl Lesion count
13.0  (0.5) 10.4  (0.5)
4.Primary Outcome
Title Co-Primary Endpoint: Absolute Change in NonInflammatory Lesion Counts From Baseline to Week 12
Hide Description [Not Specified]
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adapalene Lotion 0.1% Adapalene Lotion Vehicle 0%
Hide Arm/Group Description:
once a day for 12 weeks
once a day for 12 weeks
Overall Number of Participants Analyzed 535 531
Least Squares Mean (Standard Error)
Unit of Measure: Absolute Change in Non-Infl Lesion
19.5  (0.8) 12.9  (0.8)
5.Secondary Outcome
Title Mean Percent Change in Total Lesion Count From Baseline to Week 12
Hide Description Percent change in lesion count from baseline to week 12
Time Frame From Baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adapalene Lotion 0.1% Adapalene Lotion Vehicle 0%
Hide Arm/Group Description:
once a day for 12 weeks
once a day for 12 weeks
Overall Number of Participants Analyzed 535 531
Mean (Standard Deviation)
Unit of Measure: % Change in Lesion Count
Total lesion count -44.6  (33.2) -32.8  (34.1)
Inflammatory -46.0  (36.8) -36.9  (40.7)
Non-Inflammatory -43.1  (40.9) -30.2  (40.5)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Adapalene Lotion 0.1% Adapalene Lotion Vehicle 0%
Hide Arm/Group Description once a day for 12 weeks once a day for 12 weeks
All-Cause Mortality
Adapalene Lotion 0.1% Adapalene Lotion Vehicle 0%
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Adapalene Lotion 0.1% Adapalene Lotion Vehicle 0%
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/535 (0.00%)      0/531 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Adapalene Lotion 0.1% Adapalene Lotion Vehicle 0%
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   32/535 (5.98%)      11/531 (2.07%)    
Skin and subcutaneous tissue disorders     
Dry Skin *  32/535 (5.98%)  33 11/531 (2.07%)  11
*
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.
disclosure restriction varies per institutional request/agreement
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Michael Graeber MD/ Head of Global Clinical Project Management
Organization: Galderma
Phone: 609-860-8201
EMail: michael.graeber@galderma.com
Layout table for additonal information
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
First Submitted: January 11, 2008
First Posted: January 23, 2008
Results First Submitted: April 16, 2010
Results First Posted: April 19, 2011
Last Update Posted: April 19, 2011