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Trial record 40 of 231 for:    clindamycin

Safety and Efficacy Study of Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel to Treat Rosacea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00823901
Recruitment Status : Completed
First Posted : January 16, 2009
Results First Posted : June 15, 2012
Last Update Posted : June 25, 2012
Sponsor:
Collaborator:
Medicis Pharmaceutical Corporation
Information provided by (Responsible Party):
Alexandra Kimball, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Rosacea
Interventions Drug: Clindamycin Phosphate 1.2% And Tretinoin 0.025% Gel
Drug: Placebo gel
Enrollment 83
Recruitment Details Subjects were recruited at MGH and Stanford University Hospital.
Pre-assignment Details Some subjects required a wash-out of medications they were using. Subjects were excluded if they did not have enough lesions.
Arm/Group Title Clindamycin/Tretinoin Gel Placebo Gel
Hide Arm/Group Description Participants applied Clindamycin Phosphate 1.2% And Tretinoin 0.025% Gel on entire face (forehead, nose, cheeks, chin) once daily at night for 12 weeks Participants applied Placebo vehicle gel (with out active ingredient) on entire face (forehead, nose, cheek, chin) once daily at night for 12 weeks
Period Title: Overall Study
Started 43 [1] 40 [2]
Completed 39 [3] 38 [4]
Not Completed 4 2
Reason Not Completed
Adverse Event             1             1
Lack of Efficacy             1             0
Lost to Follow-up             2             1
[1]
Randomized to clindamycin/tretinoin gel
[2]
Randomized to placebo gel
[3]
Discontinued intervention (n=2) Only baseline completed (n=2)
[4]
Discontinued intervention (n=1) Only baseline completed (n=1)
Arm/Group Title Clindamycin/Tretinoin Gel Placebo Gel Total
Hide Arm/Group Description Participants applied Clindamycin Phosphate 1.2% And Tretinoin 0.025% Gel on entire face (forehead, nose, cheeks, chin) once daily at night for 12 weeks Participants applied Placebo vehicle gel (with out active ingredient) on entire face (forehead, nose, cheek, chin) once daily at night for 12 weeks Total of all reporting groups
Overall Number of Baseline Participants 43 40 83
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 40 participants 83 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
42
  97.7%
39
  97.5%
81
  97.6%
>=65 years
1
   2.3%
1
   2.5%
2
   2.4%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 43 participants 40 participants 83 participants
53.2  (13.6) 51.2  (14.0) 52.17  (13.74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 40 participants 83 participants
Female
28
  65.1%
31
  77.5%
59
  71.1%
Male
15
  34.9%
9
  22.5%
24
  28.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 43 participants 40 participants 83 participants
43 40 83
1.Primary Outcome
Title Mean Change in Number of Inflammatory Lesions From Baseline to Week 12
Hide Description The number of inflammatory lesions (papules and pustules) on the face were counted by a dermatologist at baseline and week 12 for each participant. Change in the number of inflammatory lesions is defined as week 12 values minus the baseline values of the participant. Last observation carried forward (LOCF) method was used for missing values.
Time Frame Baseline, week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT) population. Participants who were randomized but only had baseline visit (never began treatment) were excluded from the analysis. Last observation carried forward (LOCF) was also used.
Arm/Group Title Clindamycin/Tretinoin Gel Placebo
Hide Arm/Group Description:
Participants applied Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel on entire face (forehead, nose, cheeks, chin) once daily at night for 12 weeks
Participants applied placebo gel without active ingredient on entire face (forehead, nose, cheek, chin)once daily at night for 12 weeks
Overall Number of Participants Analyzed 41 39
Mean (Standard Deviation)
Unit of Measure: lesions
.83  (10.84) -3.13  (13.28)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clindamycin/Tretinoin Gel, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.15
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame 12 weeks (duration of study participation)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Clindamycin/Tretinoin Gel Placebo Gel
Hide Arm/Group Description Participants applied Clindamycin Phosphate 1.2% And Tretinoin 0.025% Gel on entire face (forehead, nose, cheeks, chin) once daily at night for 12 weeks Participants applied Placebo vehicle gel (with out active ingredient) on entire face (forehead, nose, cheek, chin) once daily at night for 12 weeks
All-Cause Mortality
Clindamycin/Tretinoin Gel Placebo Gel
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Clindamycin/Tretinoin Gel Placebo Gel
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/43 (0.00%)      0/40 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Clindamycin/Tretinoin Gel Placebo Gel
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   29/41 (70.73%)      11/39 (28.21%)    
Skin and subcutaneous tissue disorders     
Worsening rosacea *  7/41 (17.07%)  7 4/39 (10.26%)  4
Facial scaling *  6/41 (14.63%)  6 0/39 (0.00%)  0
Facial Dryness *  5/41 (12.20%)  5 2/39 (5.13%)  2
Facial redness *  4/41 (9.76%)  4 2/39 (5.13%)  2
Facial burning sensation *  2/41 (4.88%)  2 0/39 (0.00%)  0
Facial itching *  3/41 (7.32%)  3 2/39 (5.13%)  2
Facial irritation *  2/41 (4.88%)  2 1/39 (2.56%)  1
*
Indicates events were collected by non-systematic assessment
This study is limited by relatively small number of subjects. In addition, overall assessment of acne rosacea severity as determined by subjects’ self-assessment was not performed.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Alexandra B. Kimball, MD
Organization: MGH CURTIS
Phone: 617-726-5066
EMail: harvardskinstudies@partners.org
Layout table for additonal information
Responsible Party: Alexandra Kimball, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00823901     History of Changes
Other Study ID Numbers: 2008-P-001828
First Submitted: January 14, 2009
First Posted: January 16, 2009
Results First Submitted: April 4, 2011
Results First Posted: June 15, 2012
Last Update Posted: June 25, 2012