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Trial record 20 of 232 for:    clindamycin

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

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ClinicalTrials.gov Identifier: NCT01044264
Recruitment Status : Completed
First Posted : January 7, 2010
Results First Posted : December 17, 2012
Last Update Posted : January 24, 2013
Sponsor:
Information provided by (Responsible Party):
Perrigo Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Drug: 1% Clindamycin/5% Benzoyl Peroxide Topical Gel
Drug: Placebo
Enrollment 602
Recruitment Details FIRST PATIENT ENROLLED: 12/11/2007 LAST PATIENT COMPLETED: 9/18/2008
Pre-assignment Details  
Arm/Group Title 1% Clindamycin/5% Benzoyl Peroxide Topical Gel DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel Placebo
Hide Arm/Group Description

Test product

1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel

Reference product

1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel

Placebo : Placebo
Period Title: Overall Study
Started 200 202 200
Completed 110 108 108
Not Completed 90 94 92
Arm/Group Title 1% Clindamycin/5% Benzoyl Peroxide Topical Gel DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel Placebo Total
Hide Arm/Group Description

Test product

1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel

Reference product

1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel

Placebo : Placebo Total of all reporting groups
Overall Number of Baseline Participants 200 202 200 602
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 200 participants 202 participants 200 participants 602 participants
<=18 years
117
  58.5%
113
  55.9%
113
  56.5%
343
  57.0%
Between 18 and 65 years
83
  41.5%
89
  44.1%
87
  43.5%
259
  43.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 200 participants 202 participants 200 participants 602 participants
19.2  (7.3) 19.5  (7.1) 20.1  (8.3) 19.6  (7.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 200 participants 202 participants 200 participants 602 participants
Female
103
  51.5%
101
  50.0%
113
  56.5%
317
  52.7%
Male
97
  48.5%
101
  50.0%
87
  43.5%
285
  47.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 200 participants 202 participants 200 participants 602 participants
200 202 200 602
1.Primary Outcome
Title Reduction of Inflammatory Lesions
Hide Description The primary endpoint of the study was the mean percent reduction from baseline to week 11 in inflamed lesion count (papules and pustules).
Time Frame Baseline and week 11
Hide Outcome Measure Data
Hide Analysis Population Description
per-protocol population
Arm/Group Title 1% Clindamycin/5% Benzoyl Peroxide Topical Gel DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel Placebo
Hide Arm/Group Description:

Test product

1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel

Reference product

1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel

Placebo : Placebo
Overall Number of Participants Analyzed 110 108 185
Measure Type: Number
Unit of Measure: percentage reduction of lesions
64.39 63.10 49.89
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1% Clindamycin/5% Benzoyl Peroxide Topical Gel, DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments BE of the test to reference in the per protocol population
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Wilcoxon Rank Sum Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Wilcoxon Rank Sum Test
Estimated Value 100
Confidence Interval (2-Sided) 90%
92.47 to 113.54
Estimation Comments [Not Specified]
Time Frame 11 week treatment period
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 1% Clindamycin/5% Benzoyl Peroxide Topical Gel DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel Placebo
Hide Arm/Group Description

Test product

1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel

Reference product

1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel

Placebo : Placebo
All-Cause Mortality
1% Clindamycin/5% Benzoyl Peroxide Topical Gel DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
1% Clindamycin/5% Benzoyl Peroxide Topical Gel DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1      0      1    
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Kidney Cancer * 1  1/200 (0.50%)  1 0/202 (0.00%)  0 0/200 (0.00%)  0
Psychiatric disorders       
Mild Bipolar Conduct Disorder * 1  0/200 (0.00%)  0 0/202 (0.00%)  0 1/200 (0.50%)  1
Renal and urinary disorders       
Hematuria * 1  1/200 (0.50%)  1 0/202 (0.00%)  0 0/200 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
1% Clindamycin/5% Benzoyl Peroxide Topical Gel DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   40/200 (20.00%)      35/202 (17.33%)      28/200 (14.00%)    
Ear and labyrinth disorders       
Nasopharyngitis * 1  4/200 (2.00%)  3/202 (1.49%)  2/200 (1.00%) 
Infections and infestations       
Influenza * 1  4/200 (2.00%)  1/202 (0.50%)  1/200 (0.50%) 
Nervous system disorders       
headache * 1  3/200 (1.50%)  8/202 (3.96%)  3/200 (1.50%) 
Skin and subcutaneous tissue disorders       
application site dryness * 1  25/200 (12.50%)  21/202 (10.40%)  21/200 (10.50%) 
Application Site Burning * 1  4/200 (2.00%)  2/202 (0.99%)  1/200 (0.50%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.0)
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: Manager
Organization: Perrigo Company
Phone: 718-960-0119
EMail: jonathan.schwartz@perrigo.com
Layout table for additonal information
Responsible Party: Perrigo Company
ClinicalTrials.gov Identifier: NCT01044264     History of Changes
Obsolete Identifiers: NCT00807638
Other Study ID Numbers: DAC-501-601-727998
First Submitted: January 4, 2010
First Posted: January 7, 2010
Results First Submitted: September 14, 2012
Results First Posted: December 17, 2012
Last Update Posted: January 24, 2013