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Trial record 53 of 232 for:    clindamycin

Study to Determine and Compare the Tolerance and Irritation Potential of Topical Acne Medications

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ClinicalTrials.gov Identifier: NCT00964366
Recruitment Status : Completed
First Posted : August 24, 2009
Results First Posted : April 3, 2012
Last Update Posted : May 30, 2017
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Stiefel, a GSK Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Drug: clindamycin and benzoyl peroxide
Drug: Dapsone gel
Enrollment 53
Recruitment Details Clinical research center. Subject recruitment occurred from July 16, 2009 to Aug. 11, 2009
Pre-assignment Details Panelists who met the eligibility criteria and were willing to participate in the study were required to undergo a 3-day pre-trial conditioning period where they had to stop the use of all facial products. Panelists were required to use the provided Soap Free Cleanser (SFC) for washing their face and were allowed to apply their normal makeup.
Arm/Group Title Clindamycin and BPO Gel Dapsone Gel
Hide Arm/Group Description Daily applications of Clindamycin and benzoyl peroxide gel to one-half of the face. Clindamycin and benzoyl peroxide facial gel was applied daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe). Twice-daily applications of dapsone gel to one-half of the face. Dapsone facial gel was applied twice daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
Period Title: Overall Study
Started 28 [1] 25
Completed 27 24
Not Completed 1 1
Reason Not Completed
Did not qualify at Day 1             1             0
Withdrawal by Subject             0             1
[1]
27 of the 28 enrolled were eligible after screening.
Arm/Group Title Clindamycin and BPO Gel Dapsone Gel Total
Hide Arm/Group Description Daily applications of Clindamycin and benzoyl peroxide gel to one-half of the face. Clindamycin and benzoyl peroxide facial gel was applied daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe). Twice-daily applications of dapsone gel to one-half of the face. Dapsone facial gel was applied twice daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe). Total of all reporting groups
Overall Number of Baseline Participants 28 25 53
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 25 participants 53 participants
<=18 years
2
   7.1%
1
   4.0%
3
   5.7%
Between 18 and 65 years
26
  92.9%
24
  96.0%
50
  94.3%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 25 participants 53 participants
Female
21
  75.0%
22
  88.0%
43
  81.1%
Male
7
  25.0%
3
  12.0%
10
  18.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 28 participants 25 participants 53 participants
28 25 53
1.Primary Outcome
Title Skin Erythema (Redness)
Hide Description

Assessment of erythema as part of an evaluation of tolerance of two treatments: clindamycin and benzoyl peroxide or dapsone gel. This was done by visual assessment by an independent blinded grader using the grading scale shown below.

Grade Description 0 None 2 Mild erythema 4 Moderate confluent erythema 6 Marked erythema with some edema 8 Marked erythema, edema, possible erosion

Time Frame 2 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Clindamycin and BPO Gel Dapsone Gel
Hide Arm/Group Description:
Daily applications of Clindamycin and benzoyl peroxide gel to one-half of the face. Clindamycin and benzoyl peroxide facial gel was applied daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
Twice-daily applications of dapsone gel to one-half of the face. Dapsone facial gel was applied twice daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
Overall Number of Participants Analyzed 27 25
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 1.06  (0.79) 1.18  (0.63)
Day 1 1.26  (.76) 1.34  (.81)
Day 2 1.55  (.84) 1.33  (.85)
Day 3 1.32  (.63) 1.50  (.59)
Day 6 1.30  (.75) 1.65  (.92)
Day 7 1.64  (1.02) 1.53  (.82)
Day 8 1.80  (.80) 1.60  (.93)
Day 9 1.67  (.95) 1.45  (.89)
Day 10 1.81  (.89) 1.85  (1.13)
Day 13 1.52  (1.20) 1.65  (1.05)
Day 14 2.10  (1.09) 1.90  (1.15)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clindamycin and BPO Gel, Dapsone Gel
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 Dunn's Multiple Comparisons Test
Comments [Not Specified]
2.Primary Outcome
Title Skin Dryness
Hide Description

The amount of dryness on the left and right cheek of each panelist.

The scale used to evaluate skin dryness is:

Grade Description 0 None 2 Slight flaking 4 Moderate flaking/scaling 6 Marked scaling / slight fissuring 8 Severe scaling, fissuring

Expert Grader assessments of dryness were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14.

Time Frame Baseline, Day 1through Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Clindamycin and BPO Gel Dapsone Gel
Hide Arm/Group Description:
Daily applications of Clindamycin and benzoyl peroxide gel to one-half of the face. Clindamycin and benzoyl peroxide facial gel was applied daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
Twice-daily applications of dapsone gel to one-half of the face. Dapsone facial gel was applied twice daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
Overall Number of Participants Analyzed 27 25
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 0.11  (0.32) 0.12  (0.33)
Day 1 0.04  (0.05) 0.28  (0.71)
Day 2 0.10  (0.26) 0.23  (0.57)
Day 3 0.16  (0.32) 0.48  (0.81)
Day 6 0.27  (0.79) 0.37  (0.64)
Day 7 0.21  (0.45) 0.23  (0.47)
Day 8 0.54  (1.03) 0.17  (0.35)
Day 9 0.5  (1.04) 0.10  (0.20)
Day 10 0.57  (0.91) 0.15  (0.44)
Day 13 0.57  (1.24) 0.17  (0.45)
Day 14 0.55  (1.11) 0.12  (0.28)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clindamycin and BPO Gel, Dapsone Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.05
Comments Dapsone versus Clindamycin/BPO gel.
Method Dunn's Multiple Comparisons Test
Comments [Not Specified]
3.Secondary Outcome
Title Transepidermal Water Loss (TEWL)
Hide Description To assess skin moisture and hydration using transepidermal water loss (TEWL). These tables record the data obtained for each panelist at Baseline, and on Days 3, 7 and 14 or upon early termination of site(s), if applicable. Results are measured on a continuous scale.
Time Frame 2 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clindamycin and BPO Gel Dapsone Gel
Hide Arm/Group Description:
Daily applications of Clindamycin and benzoyl peroxide gel to one-half of the face. Clindamycin and benzoyl peroxide facial gel was applied daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
Twice-daily applications of dapsone gel to one-half of the face. Dapsone facial gel was applied twice daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
Overall Number of Participants Analyzed 27 25
Mean (Standard Deviation)
Unit of Measure: TEWL rates (gm/m2/hr)
Baseline 10.29  (3.06) 10.4  (2.93)
Day 3 12.34  (4.80) 11.21  (3.26)
Day 7 14.39  (3.73) 11.53  (3.09)
Day 14 13.88  (3.70) 11.26  (3.08)
4.Secondary Outcome
Title Sebum Measurements
Hide Description To sample the skin surface, the sebum collector strips are applied to the skin sites for 10 seconds. Once removed, these samples will be immediately measured for the amount of sebum on the strip using the tape analyzer. The amount of sebum production was measured as the amount of sebum collected on a tape applied to the skin for 10 seconds and then converted to 1 of 10 incremental levels. Sebum production was measured in increments of 0 (minimum value) to 10 (maximum value). The higher the number, the greater amount of sebum produced.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Clindamycin and BPO Gel Dapsone Gel
Hide Arm/Group Description:
Daily applications of Clindamycin and benzoyl peroxide gel to one-half of the face. Clindamycin and benzoyl peroxide facial gel was applied daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
Twice-daily applications of dapsone gel to one-half of the face. Dapsone facial gel was applied twice daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
Overall Number of Participants Analyzed 27 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 1.72  (1.31) 2.18  (1.73)
Day 3 1.52  (1.01) 1.72  (1.11)
Day 7 2.65  (2.05) 3.33  (2.43)
Day 14 2.35  (2.01) 2.38  (1.67)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clindamycin and BPO Gel, Dapsone Gel
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 ANOVA
Comments [Not Specified]
5.Secondary Outcome
Title Skin Hydration
Hide Description Evaluation of Skin Hydration using electrical conductance measurements,on weekdays during 14 days of treatment. The value recorded which is expressed in units of microsiemens represents the AC conductance 2-3 seconds after placing the spring-loaded probe tip to the sample site.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Clindamycin and BPO Gel Dapsone Gel
Hide Arm/Group Description:
Daily applications of Clindamycin and benzoyl peroxide gel to one-half of the face. Clindamycin and benzoyl peroxide facial gel was applied daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
Twice-daily applications of dapsone gel to one-half of the face. Dapsone facial gel was applied twice daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
Overall Number of Participants Analyzed 27 25
Mean (Standard Deviation)
Unit of Measure: Microsiemens
Baseline 499.51  (124.27) 448.31  (149.26)
4 hours post 1st treatment 430.38  (156.71) 404.68  (170.45)
Day 3 614.73  (144.64) 511.63  (163.97)
Day 7 460.65  (169.03) 456.73  (173.07)
Day 14 477.80  (173.40) 471.13  (194.77)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clindamycin and BPO Gel, Dapsone Gel
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 ANOVA
Comments [Not Specified]
Time Frame 14 days.
Adverse Event Reporting Description Any study product-related AEs ongoing at the end of the treatment period were followed until they resolve, the condition stabilizes, the events are otherwise explained, or the subject is lost to follow-up. In addition, all SAEs were followed until resolution as previously stated for study product-related AEs.
 
Arm/Group Title Clindamycin and BPO Gel Dapsone Gel
Hide Arm/Group Description Daily applications of Clindamycin and benzoyl peroxide gel to one-half of the face. Clindamycin and benzoyl peroxide facial gel was applied daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe). Twice-daily applications of dapsone gel to one-half of the face. Dapsone facial gel was applied twice daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
All-Cause Mortality
Clindamycin and BPO Gel Dapsone Gel
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Clindamycin and BPO Gel Dapsone Gel
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/27 (0.00%)      0/25 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Clindamycin and BPO Gel Dapsone Gel
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/27 (7.41%)      2/25 (8.00%)    
Infections and infestations     
Infection * [1]  1/27 (3.70%)  1 1/25 (4.00%)  1
Nervous system disorders     
Headache * [2]  1/27 (3.70%)  1 1/25 (4.00%)  1
*
Indicates events were collected by non-systematic assessment
[1]
One subject had a urinary tract infeaction in the dapsone treatment group and one subject had a vaginal yeast infection on the clindamycin/ BPO treatment group. Neither of these was reported as being related to the study drug by the investigator.
[2]
One subject on the clinicamycin/BPO arm was reported to have a headache and one subject on the dapsone arm was reported to have a migrane headache. Neither of these was reported as being related to the study drug by the investigator.
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: GSK Response Center
Organization: GlaxoSmithKline
Phone: 888-435-7343
Layout table for additonal information
Responsible Party: GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier: NCT00964366     History of Changes
Other Study ID Numbers: 114545
C0000-408
First Submitted: August 20, 2009
First Posted: August 24, 2009
Results First Submitted: April 13, 2010
Results First Posted: April 3, 2012
Last Update Posted: May 30, 2017