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Trial record 11 of 141 for:    acne AND erythema

Compare the Tolerance of Clindamycin 1% /Benzoyl Peroxide (BPO) 5% Gel to Clindamycin 1.2%/ BPO 2.5% Topical Medications

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: NCT01015638
Recruitment Status : Completed
First Posted : November 18, 2009
Results First Posted : February 13, 2012
Last Update Posted : March 31, 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 (Investigator);   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Drug: Clindamycin and BPO 5% gel
Drug: Clindamycin phosphate and benzoyl peroxide 2.5% gel.
Enrollment 36
Recruitment Details Clinical research center. Enrollment started: 11 Aug 2009 Last patient last visit: 1 Sep 2009
Pre-assignment Details Subjects who met inclusion and exclusion criteria and are willing to participate in the study were required to undergo a 3-day screening period where they will stop the use of all facial products on their face. Subjects were required to use soap free cleanser for washing their face and may apply their normal makeup.
Arm/Group Title Clindamycin and BPO 5% Gel Clindamycin Phosphate and BPO 2.5% Gel
Hide Arm/Group Description Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel. Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
Period Title: Overall Study
Started 17 19
Completed 16 19
Not Completed 1 0
Reason Not Completed
Withdrawal by Subject             1             0
Arm/Group Title Clindamycin and BPO 5% Gel Clindamycin Phosphate and BPO 2.5% Gel Total
Hide Arm/Group Description Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel. Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel. Total of all reporting groups
Overall Number of Baseline Participants 17 19 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 19 participants 36 participants
<=18 years
1
   5.9%
0
   0.0%
1
   2.8%
Between 18 and 65 years
16
  94.1%
19
 100.0%
35
  97.2%
>=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 17 participants 19 participants 36 participants
Female
11
  64.7%
15
  78.9%
26
  72.2%
Male
6
  35.3%
4
  21.1%
10
  27.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 17 participants 19 participants 36 participants
17 19 36
1.Primary Outcome
Title Erythema (Redness)
Hide Description

Compare tolerability of clindamycin and benzoyl peroxide (BPO) 5% and clindamycin phosphate and benzoyl peroxide 2.5% using visual assessments by an independent blinded grader.

Erythema (redness) was evaluated using the following scale:

Erythema 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 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Clindamycin and BPO 5% Gel Clindamycin Phosphate and BPO 2.5% Gel
Hide Arm/Group Description:
Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
Overall Number of Participants Analyzed 17 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
Day 0 0.94  (0.83) 1.05  (0.78)
Day 1 1.42  (1.32) 1.24  (.70)
Day 2 1.45  (1.18) 1.49  (1.33)
Day 3 1.27  (.96) 1.36  (1.14)
Day 6 1.55  (1.15) 1.87  (1.23)
Day 7 1.72  (1.14) 1.88  (1.25)
Day 8 1.39  (.86) 1.70  (1.38)
Day 9 1.38  (1.00) 1.82  (1.38)
Day 10 1.78  (1.26) 1.72  (1.18)
Day 13 1.34  (1.03) 1.82  (1.44)
Day 14 1.51  (1.06) 1.82  (1.18)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clindamycin and BPO 5% Gel, Clindamycin Phosphate and BPO 2.5% 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 Kruskal-Wallis
Comments [Not Specified]
2.Primary Outcome
Title Skin Dryness
Hide Description

Visual Dryness was evaluated using the following scale:

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

Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Clindamycin and BPO 5% Gel Clindamycin Phosphate and BPO 2.5% Gel
Hide Arm/Group Description:
Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
Overall Number of Participants Analyzed 17 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
Day 0 0.06  (0.24) 0.05  (0.23)
Day 1 0.05  (0.05) 0.15  (0.30)
Day 2 0.05  (0.05) 0.37  (0.66)
Day 3 0.27  (0.55) 0.22  (0.37)
Day 6 0.29  (0.55) 0.24  (0.53)
Day 7 0.32  (0.54) 0.15  (0.45)
Day 8 0.40  (0.59) 0.15  (0.32)
Day 9 0.35  (0.56) 0.15  (0.30)
Day 10 0.47  (1.04) 0.36  (0.99)
Day 13 0.76  (1.33) 0.28  (0.46)
Day 14 0.62  (1.05) 0.31  (0.54)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clindamycin and BPO 5% Gel, Clindamycin Phosphate and BPO 2.5% 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 Kruskal-Wallis
Comments [Not Specified]
3.Secondary Outcome
Title Skin Moisture and Hydration
Hide Description

To assess skin moisture and hydration using transepidermal water loss (TEWL). Results are measured on a continuous scale as grams per meters squared (m^2) per hour. Higher values indicate greater water loss/ lower skin moisture levels.

Evaporative water loss measurements provide an instrumental assessment of skin barrier function(one of the layers of the skin. Damage leads to a disruption of the barrier that is accompanied by elevated water loss rates and affects skin moisture and hydration.

Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clindamycin and BPO 5% Gel Clindamycin Phosphate and BPO 2.5% Gel
Hide Arm/Group Description:
Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
Overall Number of Participants Analyzed 17 19
Mean (Standard Deviation)
Unit of Measure: grams/m^2/hour
Day 0 10.82  (4.15) 9.71  (3.14)
Day 3 11.98  (4.18) 10.84  (3.46)
Day 7 13.01  (3.16) 11.36  (2.91)
Day 14 13.94  (4.10) 13.59  (4.68)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clindamycin and BPO 5% Gel, Clindamycin Phosphate and BPO 2.5% 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]
4.Secondary Outcome
Title Changes in the Skin Surface Hydration
Hide Description

The ability of an alternating current to flow through the stratum corneum is an indirect measure of its water content. The value recorded is expressed in microsiemens. Higher values indicate greater levels of skin hydration.

Test results were compared to measurements from the other side of the face, which was not treated instead of referring to a normal range. A normal range does not exist for this measurement. Instead, the non-treated side of the face was used as a control to determine the normal level of skin hydration.

Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Clindamycin and BPO 5% Gel Clindamycin Phosphate and BPO 2.5% Gel
Hide Arm/Group Description:
Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
Overall Number of Participants Analyzed 17 19
Mean (Standard Deviation)
Unit of Measure: microsiemens
Day 0 546.40  (185.75) 478.02  (170.88)
4 Hours Post 1st Treatment 554.00  (202.94) 430.78  (158.98)
Day 3 572.39  (200.31) 529.96  (124.88)
Day 7 484.94  (212.56) 413.51  (131.31)
Day 14 361.59  (177.01) 354.46  (144.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clindamycin and BPO 5% Gel, Clindamycin Phosphate and BPO 2.5% 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 Tukey-Kramer Multiple Comparisons Test
Comments [Not Specified]
5.Secondary Outcome
Title Subject Tolerability - Burning
Hide Description

At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate burning, stinging, pain, and dryness in this questionnaire. Each symptom was rated with the following scale: 0 – None, 1 – Slight, 2 – Moderate, or 3 – Severe.

The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of burning are presented here.

Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Clindamycin and BPO 5% Gel Clindamycin Phosphate and BPO 2.5% Gel
Hide Arm/Group Description:
Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
Overall Number of Participants Analyzed 17 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
Day 0 0.00  (0.00) 0.00  (0.00)
Day 1 0.00  (0.00) 0.00  (0.00)
Day 2 0.00  (0.00) 0.00  (0.00)
Day 3 0.00  (0.00) 0.00  (0.00)
Day 6 0.00  (0.00) 0.00  (0.00)
Day 7 0.00  (0.00) 0.00  (0.00)
Day 8 0.00  (0.00) 0.00  (0.00)
Day 9 0.00  (0.00) 0.00  (0.00)
Day 10 0.00  (0.00) 0.00  (0.00)
Day 13 0.00  (0.00) 0.00  (0.00)
Day 14 0.00  (0.00) 0.00  (0.00)
6.Secondary Outcome
Title Subject Tolerability - Stinging
Hide Description

At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate burning, stinging, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 – None,1 – Slight,2 – Moderate, or 3 – Severe.

The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of stinging are presented here.

Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clindamycin and BPO 5% Gel Clindamycin Phosphate and BPO 2.5% Gel
Hide Arm/Group Description:
Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
Overall Number of Participants Analyzed 17 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
Day 0 0.00  (0.00) 0.00  (0.00)
Day 1 0.00  (0.00) 0.00  (0.00)
Day 2 0.06  (0.24) 0.00  (0.00)
Day 3 0.00  (0.00) 0.05  (0.23)
Day 6 0.00  (0.00) 0.05  (0.23)
Day 7 0.00  (0.00) 0.00  (0.00)
Day 8 0.00  (0.00) 0.00  (0.00)
Day 9 0.00  (0.00) 0.00  (0.00)
Day 10 0.00  (0.00) 0.05  (0.23)
Day 13 0.00  (0.00) 0.00  (0.00)
Day 14 0.00  (0.00) 0.11  (0.46)
7.Secondary Outcome
Title Subject Assessment - Dryness
Hide Description

At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate burning, stinging, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 – None, 1 – Slight, 2 – Moderate, or 3 – Severe.

The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of dryness are presented here.

Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clindamycin and BPO 5% Gel Clindamycin Phosphate and BPO 2.5% Gel
Hide Arm/Group Description:
Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
Overall Number of Participants Analyzed 17 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
Day 0 0.00  (0.00) 0.26  (0.56)
Day 1 0.00  (0.00) 0.26  (0.56)
Day 2 0.00  (0.00) 0.21  (0.54)
Day 3 0.00  (0.00) 0.11  (0.46)
Day 6 0.06  (0.24) 0.11  (0.32)
Day 7 0.12  (0.49) 0.21  (0.54)
Day 8 0.12  (0.49) 0.16  (0.50)
Day 9 0.2  (0.5) 0.16  (0.50)
Day 10 0.24  (0.56) 0.16  (0.50)
Day 13 0.35  (0.70) 0.16  (0.50)
Day 14 0.24  (0.56) 0.21  (0.63)
8.Secondary Outcome
Title Subject Assessment - Roughness
Hide Description

At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate burning, stinging, roughness, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 – None, 1 – Slight, 2 – Moderate, or 3 – Severe.

The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of roughness are presented here.

Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clindamycin and BPO 5% Gel Clindamycin Phosphate and BPO 2.5% Gel
Hide Arm/Group Description:
Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
Overall Number of Participants Analyzed 17 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
Day 0 0.00  (0.00) 0.00  (0.00)
Day 1 0.00  (0.00) 0.05  (0.23)
Day 2 0.00  (0.00) 0.00  (0.00)
Day 3 0.00  (0.00) 0.00  (0.00)
Day 6 0.06  (0.24) 0.00  (0.00)
Day 7 0.06  (0.24) 0.00  (0.00)
Day 8 0.06  (0.24) 0.05  (0.23)
Day 9 0.18  (0.53) 0.05  (0.23)
Day 10 0.12  (0.49) 0.05  (0.23)
Day 13 0.00  (0.00) 0.05  (0.23)
Day 14 0.00  (0.00) 0.05  (0.23)
9.Secondary Outcome
Title Subject Assessment - Pain
Hide Description

At each visit, panelists were supplied a self-assessment questionnaire, which included assessment of pain.

Subjects were asked to evaluate burning, stinging, pain, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 – None, 1 – Slight, 2 – Moderate, or 3 – Severe.

The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of pain are presented here.

Time Frame 2 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clindamycin and BPO 5% Gel Clindamycin Phosphate and BPO 2.5% Gel
Hide Arm/Group Description:
Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
Overall Number of Participants Analyzed 17 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
Day 0 0.00  (0.00) 0.00  (0.00)
Day 1 0.00  (0.00) 0.00  (0.00)
Day 2 0.00  (0.00) 0.00  (0.00)
Day 3 0.00  (0.00) 0.00  (0.00)
Day 6 0.00  (0.00) 0.00  (0.00)
Day 7 0.00  (0.00) 0.00  (0.00)
Day 8 0.00  (0.00) 0.00  (0.00)
Day 9 0.00  (0.00) 0.00  (0.00)
Day 10 0.00  (0.00) 0.00  (0.00)
Day 13 0.00  (0.00) 0.00  (0.00)
Day 14 0.00  (0.00) 0.00  (0.00)
10.Secondary Outcome
Title Subject Assessment - Crusting
Hide Description

At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate crusting, burning, stinging, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 – None, 1 – Slight, 2 – Moderate, or 3 – Severe.

The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of crusting are presented here.

Time Frame 2 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clindamycin and BPO 5% Gel Clindamycin Phosphate and BPO 2.5% Gel
Hide Arm/Group Description:
Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
Overall Number of Participants Analyzed 17 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
Day 0 0.00  (0.00) 0.00  (0.00)
Day 1 0.00  (0.00) 0.00  (0.00)
Day 2 0.00  (0.00) 0.00  (0.00)
Day 3 0.00  (0.00) 0.00  (0.00)
Day 6 0.00  (0.00) 0.00  (0.00)
Day 7 0.00  (0.00) 0.00  (0.00)
Day 8 0.00  (0.00) 0.00  (0.00)
Day 9 0.00  (0.00) 0.00  (0.00)
Day 10 0.00  (0.00) 0.00  (0.00)
Day 13 0.00  (0.00) 0.00  (0.00)
Day 14 0.00  (0.00) 0.00  (0.00)
11.Secondary Outcome
Title Subject Assessment - Blistering
Hide Description

At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate blistering, burning, stinging, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 – None, 1 – Slight, 2 – Moderate, or 3 – Severe.

The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of blistering are presented here.

Time Frame 2 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clindamycin and BPO 5% Gel Clindamycin Phosphate and BPO 2.5% Gel
Hide Arm/Group Description:
Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
Overall Number of Participants Analyzed 17 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
Day 0 0.00  (0.00) 0.00  (0.00)
Day 1 0.00  (0.00) 0.00  (0.00)
Day 2 0.00  (0.00) 0.00  (0.00)
Day 3 0.00  (0.00) 0.00  (0.00)
Day 6 0.00  (0.00) 0.00  (0.00)
Day 7 0.00  (0.00) 0.00  (0.00)
Day 8 0.00  (0.00) 0.00  (0.00)
Day 9 0.00  (0.00) 0.00  (0.00)
Day 10 0.00  (0.00) 0.00  (0.00)
Day 13 0.00  (0.00) 0.00  (0.00)
Day 14 0.00  (0.00) 0.00  (0.00)
12.Secondary Outcome
Title Subject Assessment - Oiliness
Hide Description

At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate oiliness, burning, stinging, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 – None, 1 – Slight, 2 – Moderate, or 3 – Severe.

The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of oiliness are presented here.

Time Frame 2 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clindamycin and BPO 5% Gel Clindamycin Phosphate and BPO 2.5% Gel
Hide Arm/Group Description:
Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
Overall Number of Participants Analyzed 17 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
Day 0 0.18  (0.53) 0.16  (0.37)
Day 1 0.18  (0.39) 0.05  (0.23)
Day 2 0.06  (0.24) 0.00  (0.00)
Day 3 0.12  (0.33) 0.11  (0.46)
Day 6 0.06  (0.24) 0.00  (0.00)
Day 7 0.06  (0.24) 0.00  (0.00)
Day 8 0.06  (0.24) 0.00  (0.00)
Day 9 0.06  (0.24) 0.00  (0.00)
Day 10 0.00  (0.00) 0.00  (0.00)
Day 13 0.00  (0.00) 0.00  (0.00)
Day 14 0.00  (0.00) 0.00  (0.00)
Time Frame 2 weeks
Adverse Event Reporting Description Any study product-related AEs ongoing at the end of the treatment period would be followed until resolved, the condition stabilized, the events are otherwise explained, or the subject was lost to follow-up. In addition, all SAEs would have been followed until resolution as previously stated for study product-related AEs.
 
Arm/Group Title Clindamycin and BPO 5% Gel Clindamycin Phosphate and BPO 2.5% Gel
Hide Arm/Group Description Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel. Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
All-Cause Mortality
Clindamycin and BPO 5% Gel Clindamycin Phosphate and BPO 2.5% Gel
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Clindamycin and BPO 5% Gel Clindamycin Phosphate and BPO 2.5% Gel
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/17 (0.00%)      0/19 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Clindamycin and BPO 5% Gel Clindamycin Phosphate and BPO 2.5% Gel
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/17 (11.76%)      3/19 (15.79%)    
Nervous system disorders     
Headache * 1  2/17 (11.76%)  2 3/19 (15.79%)  5
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, Headache
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: GSK Response Center
Organization: GlaxoSmithKline
Phone: 88-435-7343
Responsible Party: GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier: NCT01015638     History of Changes
Other Study ID Numbers: 114546
First Submitted: November 17, 2009
First Posted: November 18, 2009
Results First Submitted: July 12, 2010
Results First Posted: February 13, 2012
Last Update Posted: March 31, 2017