Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Adherence to Study Medication Compared to Generic Topical Clindamycin Plus Generic Topical Tretinoin in Subjects With Mild to Moderate Acne Vulgaris

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: NCT01047189
Recruitment Status : Completed
First Posted : January 12, 2010
Results First Posted : October 17, 2011
Last Update Posted : September 10, 2018
Sponsor:
Collaborator:
Medicis Pharmaceutical Corporation
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Drug: clindamycin phosphate 1.2% and tretinoin 0.025%
Drug: clindamycin 1% gel
Drug: tretinoin 0.025% cream
Enrollment 26
Recruitment Details Participants were recruited from IRB approved advertising and the Wake Forest University Health Sciences Dermatology Clinic
Pre-assignment Details  
Arm/Group Title Ziana Gel Clindamycin Plus Tretinoin Applied Separately
Hide Arm/Group Description Ziana gel (clindamycin phosphate 1.2% and tretinoin 0.025%) applied once daily for 12 weeks Generic clindamycin 1% gel plus tretinoin 0.025% cream
Period Title: Overall Study
Started 13 13
Completed 9 13
Not Completed 4 0
Arm/Group Title Ziana Gel Clindamycin Plus Tretinoin Applied Separately Total
Hide Arm/Group Description Ziana gel (clindamycin phosphate 1.2% and tretinoin 0.025%) applied once daily for 12 weeks Generic clindamycin 1% gel plus tretinoin 0.025% cream Total of all reporting groups
Overall Number of Baseline Participants 13 13 26
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 26 participants
<=18 years
7
  53.8%
2
  15.4%
9
  34.6%
Between 18 and 65 years
6
  46.2%
11
  84.6%
17
  65.4%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 13 participants 13 participants 26 participants
20.1
(13 to 35)
26.2
(15 to 40)
23.1
(13 to 40)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 26 participants
Female
9
  69.2%
6
  46.2%
15
  57.7%
Male
4
  30.8%
7
  53.8%
11
  42.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants 13 participants 26 participants
13 13 26
1.Primary Outcome
Title Measured Adherence to ZIANA Gel or Generic Topical Clindamycin 1% Gel Each Morning Plus Generic Topical Tretinoin 0.025% Cream Each Evening in Subjects With Mild to Moderate Acne
Hide Description Percentage of prescribed doses taken as measured by a Medication Event Monitoring System (MEMS) cap
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients were analyzed up to end of treatment or last visit.
Arm/Group Title Ziana Gel Clindamycin Plus Tretinoin Applied Separately
Hide Arm/Group Description:
Ziana gel (clindamycin phosphate 1.2% and tretinoin 0.025%) applied once daily for 12 weeks
Generic clindamycin 1% gel plus tretinoin 0.025% cream
Overall Number of Participants Analyzed 13 13
Median (Full Range)
Unit of Measure: Percent of doses
88
(13 to 115)
61
(8 to 95)
2.Secondary Outcome
Title The Change (Dynamic Assessment) From Baseline to Week 12 (or End of Treatment) in Total Acne Lesion Count
Hide Description [Not Specified]
Time Frame Baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients were analyzed up to end of treatment or last visit.
Arm/Group Title Ziana Gel Clindamycin Plus Tretinoin Applied Separately
Hide Arm/Group Description:
Ziana gel (clindamycin phosphate 1.2% and tretinoin 0.025%) applied once daily for 12 weeks
Generic clindamycin 1% gel plus tretinoin 0.025% cream
Overall Number of Participants Analyzed 13 13
Mean (95% Confidence Interval)
Unit of Measure: percentage of lesions
-51
(-80 to -23)
-32
(-66 to 2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ziana Gel, Clindamycin Plus Tretinoin Applied Separately
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ziana Gel Clindamycin Plus Tretinoin Applied Separately
Hide Arm/Group Description Ziana gel (clindamycin phosphate 1.2% and tretinoin 0.025%) applied once daily for 12 weeks Generic clindamycin 1% gel plus tretinoin 0.025% cream
All-Cause Mortality
Ziana Gel Clindamycin Plus Tretinoin Applied Separately
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Ziana Gel Clindamycin Plus Tretinoin Applied Separately
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/13 (0.00%)      0/13 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Ziana Gel Clindamycin Plus Tretinoin Applied Separately
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/13 (7.69%)      0/13 (0.00%)    
Skin and subcutaneous tissue disorders     
Burning sensation on facial skin *  1/13 (7.69%)  1 0/13 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
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
Name/Title: Steven Feldman, MD, PhD
Organization: Wake Forest University Health Sciences
Phone: 336-716-3775
Responsible Party: Wake Forest University Health Sciences ( Wake Forest University )
ClinicalTrials.gov Identifier: NCT01047189     History of Changes
Other Study ID Numbers: IRB00007137
First Submitted: January 11, 2010
First Posted: January 12, 2010
Results First Submitted: July 1, 2011
Results First Posted: October 17, 2011
Last Update Posted: September 10, 2018