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Trial record 18 of 233 for:    acne AND Percent

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

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ClinicalTrials.gov Identifier: NCT00598832
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 1075
Recruitment Details Multi center study recruitment period: First subject enrolled Nov 7, 2007; last subject completed Nov 6, 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 533 542
Completed 471 460
Not Completed 62 82
Reason Not Completed
Lack of Efficacy             3             7
Adverse Event             6             2
Withdrawal by Subject             25             36
Protocol Violation             0             2
Lost to Follow-up             24             29
Pregnancy             2             2
Physician Decision             1             4
Non compliance             1             0
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 533 542 1075
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 533 participants 542 participants 1075 participants
<=18 years
327
  61.4%
343
  63.3%
670
  62.3%
Between 18 and 65 years
206
  38.6%
199
  36.7%
405
  37.7%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 533 participants 542 participants 1075 participants
19.5  (7.1) 18.9  (6.5) 19.2  (6.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 533 participants 542 participants 1075 participants
Female
283
  53.1%
290
  53.5%
573
  53.3%
Male
250
  46.9%
252
  46.5%
502
  46.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 533 participants 542 participants 1075 participants
United States 463 468 931
Canada 70 74 144
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 533 542
Measure Type: Number
Unit of Measure: Percentage of Participants
26.3 17.3
2.Primary Outcome
Title Co-Primary Endpoint: Absolute Change in Total 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 533 542
Least Squares Mean (Standard Error)
Unit of Measure: Absolute Change in Total Lesion Count
36.7  (1.0) 25.5  (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 533 542
Least Squares Mean (Standard Error)
Unit of Measure: Absolute Change in Infl Lesion count
14.3  (0.4) 10.2  (0.4)
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 533 542
Least Squares Mean (Standard Error)
Unit of Measure: Absolute Change in Non-Infl Lesion count
22.4  (0.8) 15.3  (0.7)
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 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 533 542
Mean (Standard Deviation)
Unit of Measure: % Change in Lesion Count
Total lesion count -51.5  (29.6) -37.1  (34.2)
Inflammatory -54.9  (31.9) -40.3  (40.7)
Non-Inflammatory -49.6  (34.0) -35.7  (38.0)
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   2/533 (0.38%)      2/542 (0.37%)    
Injury, poisoning and procedural complications     
Multiple drug overdose   1/533 (0.19%)  1 0/542 (0.00%)  0
Nervous system disorders     
Cerebral hemorrhage   1/533 (0.19%)  1 0/542 (0.00%)  0
Psychiatric disorders     
Suicide attempt   0/533 (0.00%)  0 1/542 (0.18%)  1
Depression   1/533 (0.19%)  1 0/542 (0.00%)  0
Reproductive system and breast disorders     
Ovarian cyst   0/533 (0.00%)  0 1/542 (0.18%)  1
Indicates events were collected by systematic assessment
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   50/533 (9.38%)      21/542 (3.87%)    
Skin and subcutaneous tissue disorders     
Dry skin *  50/533 (9.38%)  50 21/542 (3.87%)  21
*
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
ClinicalTrials.gov Identifier: NCT00598832     History of Changes
Other Study ID Numbers: RD.06.SPR.18113
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