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Trial record 56 of 231 for:    clindamycin

Combination Therapy With Differin® Gel 0.3% and Duac® (Clindamycin/Benzoyl Peroxide Gel) in Subjects With Acne Vulgaris

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ClinicalTrials.gov Identifier: NCT00671749
Recruitment Status : Completed
First Posted : May 5, 2008
Results First Posted : March 16, 2016
Last Update Posted : March 16, 2016
Sponsor:
Information provided by (Responsible Party):
Galderma Laboratories, L.P.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Drug: adapalene gel, 0.3%
Drug: clindamycin/benzoyl peroxide gel
Enrollment 100
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Combination Therapy
Hide Arm/Group Description Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
Period Title: Overall Study
Started 100
Completed 92
Not Completed 8
Reason Not Completed
Adverse Event             2
Withdrawal by Subject             4
Protocol Violation             1
Lost to Follow-up             1
Arm/Group Title Combination Therapy
Hide Arm/Group Description Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
Overall Number of Baseline Participants 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 100 participants
18.2  (5.40)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants
Female
56
  56.0%
Male
44
  44.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants
American Indian or Alaska Native
1
   1.0%
Asian
2
   2.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
10
  10.0%
White
77
  77.0%
More than one race
10
  10.0%
Unknown or Not Reported
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants
Hispanic or Latino
7
   7.0%
Not Hispanic or Latino
93
  93.0%
Unknown or Not Reported
0
   0.0%
Duration of Acne  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 100 participants
4.0  (3.91)
Fitzpatrick Skin Type   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 100 participants
I 1
II 27
III 38
IV 22
V 4
VI 8
[1]
Measure Description:

Investigator assessment based on the standard Fitzpatrick Skin Test (Scale I to VI). Example:

TYPE 1: Highly sensitive, always burns, never tans. TYPE 2: Very sun sensitive, burns easily, tans minimally. TYPE 3: Sun sensitive skin, sometimes burns, slowly tans to light brown. TYPE 4: Minimally sun sensitive, burns minimally, always tans to moderate brown.

TYPE 5: Sun insensitive skin, rarely burns, tans well. TYPE 6: Sun insensitive, never burns, deeply pigmented

1.Primary Outcome
Title Percent Change From Baseline in Total Lesion Counts
Hide Description [Not Specified]
Time Frame 6 and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Combination Therapy
Hide Arm/Group Description:
Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
Overall Number of Participants Analyzed 100
Mean (Standard Deviation)
Unit of Measure: Percent Change
Week 6 -47  (24.43)
Week 12 -64  (24.07)
2.Secondary Outcome
Title Global Severity Assessment Success
Hide Description Global Severity was assessed on a 6 point scale (Clear, Almost Clear, Mild, Moderate, Severe). The scale was dichotomized to success or failure where success = Clear or Almost Clear
Time Frame 6 and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Combination Therapy
Hide Arm/Group Description:
Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
Overall Number of Participants Analyzed 100
Measure Type: Number
Unit of Measure: participants
Week 6 8
Week 12 42
3.Secondary Outcome
Title Global Assessment of Improvement From Baseline
Hide Description [Not Specified]
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Combination Therapy
Hide Arm/Group Description:
Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
Overall Number of Participants Analyzed 100
Measure Type: Number
Unit of Measure: participants
Clear 3
Almost Clear 40
Marked Improvement 27
Moderate Improvement 16
Minimal Improvement 5
No Change 8
Worse 1
4.Secondary Outcome
Title Worst Post Baseline Tolerability Assessment - Erythema
Hide Description Please Note: "Tolerability Assessments" were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population (n=99)
Arm/Group Title Combination Therapy
Hide Arm/Group Description:
Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
Overall Number of Participants Analyzed 99
Measure Type: Number
Unit of Measure: participants
None 29
Mild 37
Moderate 33
Severe 0
5.Secondary Outcome
Title Worst Post Baseline Tolerability Assessment - Scaling
Hide Description Please Note: "Tolerability Assessments" were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population (n=99)
Arm/Group Title Combination Therapy
Hide Arm/Group Description:
Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
Overall Number of Participants Analyzed 99
Measure Type: Number
Unit of Measure: participants
None 53
Mild 27
Moderate 16
Severe 3
6.Secondary Outcome
Title Worst Post Baseline Tolerability Assessment - Dryness
Hide Description Please Note: "Tolerability Assessments" were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population (n=99)
Arm/Group Title Combination Therapy
Hide Arm/Group Description:
Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
Overall Number of Participants Analyzed 99
Measure Type: Number
Unit of Measure: participants
None 49
Mild 27
Moderate 20
Severe 3
7.Secondary Outcome
Title Worst Post Baseline Tolerability Assessment - Burning/Stinging
Hide Description Please Note: "Tolerability Assessments" were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population (n=99)
Arm/Group Title Combination Therapy
Hide Arm/Group Description:
Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
Overall Number of Participants Analyzed 99
Measure Type: Number
Unit of Measure: participants
None 67
Mild 18
Moderate 9
Severe 5
Time Frame 12 Weeks
Adverse Event Reporting Description Please Note: "Tolerability Assessments" were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF.
 
Arm/Group Title Combination Therapy
Hide Arm/Group Description Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
All-Cause Mortality
Combination Therapy
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Combination Therapy
Affected / at Risk (%)
Total   0/99 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Combination Therapy
Affected / at Risk (%)
Total   32/99 (32.32%) 
General disorders   
Application Site Burn * 1  32/99 (32.32%) 
Application Site Dryness * 1  24/99 (24.24%) 
Application Site Erythema * 1  10/99 (10.10%) 
Application Site Exfoliation * 1  7/99 (7.07%) 
Application Site Discomfort * 1  6/99 (6.06%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
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: Elizabeth M Nieman
Organization: Galderma Laboratories, L.P.
Phone: 817-961-5000
EMail: elizabeth.nieman@galderma.com
Layout table for additonal information
Responsible Party: Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier: NCT00671749     History of Changes
Other Study ID Numbers: US10066
First Submitted: April 30, 2008
First Posted: May 5, 2008
Results First Submitted: August 12, 2014
Results First Posted: March 16, 2016
Last Update Posted: March 16, 2016