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Trial record 57 of 231 for:    clindamycin

Clinical Study Between Two Clindamycin 1%/Benzoyl Peroxide 5% Topical Gels

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ClinicalTrials.gov Identifier: NCT01138514
Recruitment Status : Completed
First Posted : June 7, 2010
Results First Posted : March 29, 2016
Last Update Posted : March 29, 2016
Sponsor:
Information provided by (Responsible Party):
Perrigo Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Drug: Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo)
Drug: Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin)
Drug: Placebo
Enrollment 1555
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Clindamycin 1%/Benzoyl Peroxide 5% Reference Product Vehicle
Hide Arm/Group Description Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo): Applied to the entire face twice daily for 10 weeks Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin): Applied to the entire face twice daily for 10 weeks Placebo: Placebo
Period Title: Overall Study
Started 522 516 517
Completed 474 463 424
Not Completed 48 53 93
Arm/Group Title Clindamycin 1%/Benzoyl Peroxide 5% Reference Product Vehicle Total
Hide Arm/Group Description Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo): Applied to the entire face twice daily for 10 weeks Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin): Applied to the entire face twice daily for 10 weeks Placebo: Placebo Total of all reporting groups
Overall Number of Baseline Participants 522 516 517 1555
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 522 participants 516 participants 517 participants 1555 participants
20.2  (7.6) 20.1  (7.4) 20.7  (8.1) 20.4  (7.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 522 participants 516 participants 517 participants 1555 participants
Female
284
  54.4%
282
  54.7%
279
  54.0%
845
  54.3%
Male
238
  45.6%
234
  45.3%
238
  46.0%
710
  45.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 522 participants 516 participants 517 participants 1555 participants
Hispanic or Latino
253
  48.5%
268
  51.9%
251
  48.5%
772
  49.6%
Not Hispanic or Latino
269
  51.5%
248
  48.1%
266
  51.5%
783
  50.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 522 participants 516 participants 517 participants 1555 participants
American Indian or Alaska Native
2
   0.4%
1
   0.2%
3
   0.6%
6
   0.4%
Asian
11
   2.1%
10
   1.9%
10
   1.9%
31
   2.0%
Native Hawaiian or Other Pacific Islander
1
   0.2%
1
   0.2%
1
   0.2%
3
   0.2%
Black or African American
90
  17.2%
80
  15.5%
98
  19.0%
268
  17.2%
White
308
  59.0%
310
  60.1%
296
  57.3%
914
  58.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
110
  21.1%
114
  22.1%
109
  21.1%
333
  21.4%
1.Primary Outcome
Title Percent Change From Baseline in Inflammatory Lesions
Hide Description [Not Specified]
Time Frame 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population
Arm/Group Title Clindamycin 1%/Benzoyl Peroxide 5% Reference Product Vehicle
Hide Arm/Group Description:
Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo): Applied to the entire face twice daily for 10 weeks
Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin): Applied to the entire face twice daily for 10 weeks
Placebo: Placebo
Overall Number of Participants Analyzed 430 419 427
Mean (Standard Deviation)
Unit of Measure: percentage of lesion reduction
79.87  (27.38) 80.86  (24.65) 45.60  (44.01)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clindamycin 1%/Benzoyl Peroxide 5%, Reference Product
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments provides 85% power of success
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method Fieller's method
Comments [Not Specified]
Method of Estimation Estimation Parameter equivalence ratio
Estimated Value 98.77
Confidence Interval (2-Sided) 90%
95.2 to 102.5
Estimation Comments [Not Specified]
2.Primary Outcome
Title Percent Change From Baseline in Non-inflammatory Lesions
Hide Description [Not Specified]
Time Frame 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population
Arm/Group Title Clindamycin 1%/Benzoyl Peroxide 5% Reference Product Vehicle
Hide Arm/Group Description:
Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo): Applied to the entire face twice daily for 10 weeks
Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin): Applied to the entire face twice daily for 10 weeks
Placebo: Placebo
Overall Number of Participants Analyzed 430 419 427
Mean (Standard Deviation)
Unit of Measure: percentage of lesion reduction
70.21  (30.48) 70.02  (28.77) 36.16  (48.15)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clindamycin 1%/Benzoyl Peroxide 5%, Reference Product
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments provides 85% power of success
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method Fieller's method
Comments [Not Specified]
Method of Estimation Estimation Parameter equivalence ratio
Estimated Value 100.27
Confidence Interval (2-Sided) 90%
95.6 to 105.2
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Participant With Clinical Success on the Investigator's Global Assessment (IGA)
Hide Description Clinical success was defined as a score of clear (0) or almost clear (1) at Week 10.
Time Frame 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
per-protocol population
Arm/Group Title Clindamycin 1%/Benzoyl Peroxide 5% Reference Product Vehicle
Hide Arm/Group Description:
Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo): Applied to the entire face twice daily for 10 weeks
Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin): Applied to the entire face twice daily for 10 weeks
Placebo
Overall Number of Participants Analyzed 430 419 427
Measure Type: Number
Unit of Measure: participants
247 234 79
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clindamycin 1%/Benzoyl Peroxide 5%, Reference Product
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Clinical success was defined as a score of clear (0) or almost clear (1) on Investigator‟s Global Assessment (IGA) at Visit 4/Week 10
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method Wald's method Yates' continuity correct
Comments [Not Specified]
Method of Estimation Estimation Parameter equivalence difference
Estimated Value 1.6
Confidence Interval (2-Sided) 90%
-4.2 to 7.4
Estimation Comments [Not Specified]
Time Frame 10 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Clindamycin 1%/Benzoyl Peroxide 5% Reference Product Vehicle
Hide Arm/Group Description Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo): Applied to the entire face twice daily for 10 weeks Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin): Applied to the entire face twice daily for 10 weeks Placebo: Placebo
All-Cause Mortality
Clindamycin 1%/Benzoyl Peroxide 5% Reference Product Vehicle
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Clindamycin 1%/Benzoyl Peroxide 5% Reference Product Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/522 (0.00%)      0/516 (0.00%)      0/517 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Clindamycin 1%/Benzoyl Peroxide 5% Reference Product Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   49/522 (9.39%)      49/516 (9.50%)      72/517 (13.93%)    
General disorders       
Application Site dryness  1  32/522 (6.13%)  32 34/516 (6.59%)  34 6/517 (1.16%)  6
Skin and subcutaneous tissue disorders       
Acne  1  17/522 (3.26%)  17 16/516 (3.10%)  16 66/517 (12.77%)  66
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jonathan Schwartz
Organization: Perrigo
Phone: 718-960-9900
EMail: jonathan.schwartz@perrigo.com
Layout table for additonal information
Responsible Party: Perrigo Company
ClinicalTrials.gov Identifier: NCT01138514     History of Changes
Other Study ID Numbers: PRG-716
First Submitted: June 4, 2010
First Posted: June 7, 2010
Results First Submitted: January 5, 2016
Results First Posted: March 29, 2016
Last Update Posted: March 29, 2016