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A Clinical Study to Evaluate the Tolerability of a Topical Antibiotic and Retinoid Used in a Combined Regimen With a BPO Wash

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: NCT00891982
Recruitment Status : Completed
First Posted : May 1, 2009
Results First Posted : July 25, 2011
Last Update Posted : May 24, 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: CTGel/ BPO Wash
Drug: Soap Free Cleanser and CTGel
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CTGel Plus BPO Wash CTGel
Hide Arm/Group Description BPO Wash in the morning and CTGel in the evening Soap Free Cleanser in the morning and CTGel in the evening
Period Title: Overall Study
Started 30 31
Completed 28 30
Not Completed 2 1
Arm/Group Title CTGel Plus BPO Wash CTGel Total
Hide Arm/Group Description BPO Wash in the morning and CTGel in the evening Soap Free Cleanser in the morning and CTGel in the evening Total of all reporting groups
Overall Number of Baseline Participants 30 31 61
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants 31 participants 61 participants
<18 years 16 14 30
Between 18 and 45 years 14 17 31
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 31 participants 61 participants
Female
18
  60.0%
20
  64.5%
38
  62.3%
Male
12
  40.0%
11
  35.5%
23
  37.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 31 participants 61 participants
Hispanic or Latino
6
  20.0%
5
  16.1%
11
  18.0%
Not Hispanic or Latino
24
  80.0%
26
  83.9%
50
  82.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants 31 participants 61 participants
Black or African American 2 3 5
White 24 28 52
More than one race 4 0 4
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants 31 participants 61 participants
30 31 61
ISGA   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants 31 participants 61 participants
Grade 2 9 11 20
Grade 3 18 15 33
Grade 4 3 5 8
[1]
Measure Description: Investigator's Static Global Assessment measured on a 6 point scale where 0=normal, clear skin; 1 = skin almost clear; 2 = Some noninflammatory lesions are present, with few inflammatory lesions; 3 = Noninflammatory lesions predominate, with multiple inflammatory lesions evident; 4 = Inflammatory lesions are more apparent: many comedones and papules/pustules,there may or may not be a few nodulocystic lesions; and 5=highly inflammatory lesions predominate.
1.Primary Outcome
Title Local Tolerability - Skin Dryness
Hide Description

Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:

0 - None

  1. - Trace
  2. - Mild
  3. - Moderate
  4. - Marked
  5. - Severe
Time Frame Screening/baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CTGel Plus BPO Wash CTGel
Hide Arm/Group Description:
BPO Wash in the morning and CTGel in the evening
Soap Free Cleanser in the morning and CTGel in the evening
Overall Number of Participants Analyzed 30 31
Measure Type: Number
Unit of Measure: participants
Grade 0 28 26
Grade 1 2 4
Grade 2 0 1
Grade 3 0 0
Grade 4 0 0
Grade 5 0 0
Missing 0 0
2.Primary Outcome
Title Local Tolerability - Skin Dryness
Hide Description

Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:

0 - None

  1. - Trace
  2. - Mild
  3. - Moderate
  4. - Marked
  5. - Severe
Time Frame Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CTGel Plus BPO Wash CTGel
Hide Arm/Group Description:
BPO Wash in the morning and CTGel in the evening
Soap Free Cleanser in the morning and CTGel in the evening
Overall Number of Participants Analyzed 30 31
Measure Type: Number
Unit of Measure: participants
Grade 0 12 16
Grade 1 5 8
Grade 2 5 5
Grade 3 6 0
Grade 4 0 1
Grade 5 1 0
Missing 1 1
3.Primary Outcome
Title Local Tolerability - Skin Dryness
Hide Description

Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:

0 - None

  1. - Trace
  2. - Mild
  3. - Moderate
  4. - Marked
  5. - Severe
Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CTGel Plus BPO Wash CTGel
Hide Arm/Group Description:
BPO Wash in the morning and CTGel in the evening
Soap Free Cleanser in the morning and CTGel in the evening
Overall Number of Participants Analyzed 30 31
Measure Type: Number
Unit of Measure: participants
Grade 0 15 17
Grade 1 7 8
Grade 2 5 4
Grade 3 1 0
Grade 4 0 0
Grade 5 0 0
Missing 2 2
4.Primary Outcome
Title Local Tolerability - Skin Dryness
Hide Description

Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:

0 - None

  1. - Trace
  2. - Mild
  3. - Moderate
  4. - Marked
  5. - Severe
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CTGel Plus BPO Wash CTGel
Hide Arm/Group Description:
BPO Wash in the morning and CTGel in the evening
Soap Free Cleanser in the morning and CTGel in the evening
Overall Number of Participants Analyzed 30 31
Measure Type: Number
Unit of Measure: participants
Grade 0 19 19
Grade 1 7 11
Grade 2 2 1
Grade 3 0 0
Grade 4 0 0
Grade 5 0 0
Missing 2 0
5.Primary Outcome
Title Local Tolerability - Skin Scaling
Hide Description

Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:

0 - None

  1. - Trace
  2. - Mild
  3. - Moderate
  4. - Marked
  5. - Severe
Time Frame Screening/baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CTGel Plus BPO Wash CTGel
Hide Arm/Group Description:
BPO Wash in the morning and CTGel in the evening
Soap Free Cleanser in the morning and CTGel in the evening
Overall Number of Participants Analyzed 30 31
Measure Type: Number
Unit of Measure: Participants
Grade 0 29 28
Grade 1 1 2
Grade 2 0 1
Grade 3 0 0
Grade 4 0 0
Grade 5 0 0
Missing 0 0
6.Primary Outcome
Title Local Tolerability - Skin Scaling
Hide Description

Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:

0 - None

  1. - Trace
  2. - Mild
  3. - Moderate
  4. - Marked
  5. - Severe
Time Frame Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CTGel Plus BPO Wash CTGel
Hide Arm/Group Description:
BPO Wash in the morning and CTGel in the evening
Soap Free Cleanser in the morning and CTGel in the evening
Overall Number of Participants Analyzed 30 31
Measure Type: Number
Unit of Measure: Participants
Grade 0 13 19
Grade 1 5 5
Grade 2 5 3
Grade 3 5 2
Grade 4 1 1
Grade 5 0 0
Missing 1 1
7.Primary Outcome
Title Local Tolerability - Skin Scaling
Hide Description

Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:

0 - None

  1. - Trace
  2. - Mild
  3. - Moderate
  4. - Marked
  5. - Severe
Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CTGel Plus BPO Wash CTGel
Hide Arm/Group Description:
BPO Wash in the morning and CTGel in the evening
Soap Free Cleanser in the morning and CTGel in the evening
Overall Number of Participants Analyzed 30 31
Measure Type: Number
Unit of Measure: Participants
Grade 0 17 19
Grade 1 6 6
Grade 2 4 4
Grade 3 1 0
Grade 4 0 0
Grade 5 0 0
Missing 2 2
8.Primary Outcome
Title Local Tolerability - Skin Scaling
Hide Description

Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:

0 - None

  1. - Trace
  2. - Mild
  3. - Moderate
  4. - Marked
  5. - Severe
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CTGel Plus BPO Wash CTGel
Hide Arm/Group Description:
BPO Wash in the morning and CTGel in the evening
Soap Free Cleanser in the morning and CTGel in the evening
Overall Number of Participants Analyzed 30 31
Measure Type: Number
Unit of Measure: Participants
Grade 0 20 25
Grade 1 6 5
Grade 2 2 1
Grade 3 0 0
Grade 4 0 0
Grade 5 0 0
Missing 2 0
9.Primary Outcome
Title Local Tolerability - Erythema (Redness)
Hide Description

Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:

0 - None

  1. - Trace
  2. - Mild
  3. - Moderate
  4. - Marked
  5. - Severe
Time Frame Screening/baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CTGel Plus BPO Wash CTGel
Hide Arm/Group Description:
BPO Wash in the morning and CTGel in the evening
Soap Free Cleanser in the morning and CTGel in the evening
Overall Number of Participants Analyzed 30 31
Measure Type: Number
Unit of Measure: Participants
Grade 0 22 22
Grade 1 4 4
Grade 2 1 4
Grade 3 3 1
Grade 4 0 0
Grade 5 0 0
Missing 0 0
10.Primary Outcome
Title Local Tolerability - Erythema (Redness)
Hide Description

Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:

0 - None

  1. - Trace
  2. - Mild
  3. - Moderate
  4. - Marked
  5. - Severe
Time Frame Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CTGel Plus BPO Wash CTGel
Hide Arm/Group Description:
BPO Wash in the morning and CTGel in the evening
Soap Free Cleanser in the morning and CTGel in the evening
Overall Number of Participants Analyzed 30 31
Measure Type: Number
Unit of Measure: Participants
Grade 0 10 18
Grade 1 8 5
Grade 2 8 2
Grade 3 3 3
Grade 4 0 2
Grade 5 0 0
Missing 1 1
11.Primary Outcome
Title Local Tolerability - Erythema (Redness)
Hide Description

Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:

0 - None

  1. - Trace
  2. - Mild
  3. - Moderate
  4. - Marked
  5. - Severe
Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CTGel Plus BPO Wash CTGel
Hide Arm/Group Description:
BPO Wash in the morning and CTGel in the evening
Soap Free Cleanser in the morning and CTGel in the evening
Overall Number of Participants Analyzed 30 31
Measure Type: Number
Unit of Measure: Participants
Grade 0 17 12
Grade 1 5 9
Grade 2 5 6
Grade 3 1 2
Grade 4 0 0
Grade 5 0 0
Missing 2 2
12.Primary Outcome
Title Local Tolerability - Erythema (Redness)
Hide Description

Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:

0 - None

  1. - Trace
  2. - Mild
  3. - Moderate
  4. - Marked
  5. - Severe
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CTGel Plus BPO Wash CTGel
Hide Arm/Group Description:
BPO Wash in the morning and CTGel in the evening
Soap Free Cleanser in the morning and CTGel in the evening
Overall Number of Participants Analyzed 30 31
Measure Type: Number
Unit of Measure: Participants
Grade 0 15 16
Grade 1 5 9
Grade 2 4 4
Grade 3 4 2
Grade 4 0 0
Grade 5 0 0
Missing 2 0
13.Secondary Outcome
Title Subject Assessment of Burning/Stinging
Hide Description

Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:

0 - None

  1. - Trace
  2. - Mild
  3. - Moderate
  4. - Marked
  5. - Severe
Time Frame Screening/baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CTGel Plus BPO Wash CTGel
Hide Arm/Group Description:
BPO Wash in the morning and CTGel in the evening
Soap Free Cleanser in the morning and CTGel in the evening
Overall Number of Participants Analyzed 30 31
Measure Type: Number
Unit of Measure: Participants
Grade 0 27 26
Grade 1 2 1
Grade 2 1 3
Grade 3 0 0
Grade 4 0 1
Grade 5 0 0
Missing 0 0
14.Secondary Outcome
Title Subject Assessment of Burning/Stinging
Hide Description

Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:

0 - None

  1. - Trace
  2. - Mild
  3. - Moderate
  4. - Marked
  5. - Severe
Time Frame Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CTGel Plus BPO Wash CTGel
Hide Arm/Group Description:
BPO Wash in the morning and CTGel in the evening
Soap Free Cleanser in the morning and CTGel in the evening
Overall Number of Participants Analyzed 30 31
Measure Type: Number
Unit of Measure: Participants
Grade 0 14 15
Grade 1 7 8
Grade 2 3 3
Grade 3 5 2
Grade 4 0 0
Grade 5 0 1
Missing 1 2
15.Secondary Outcome
Title Subject Assessment of Burning/Stinging
Hide Description

Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:

0 - None

  1. - Trace
  2. - Mild
  3. - Moderate
  4. - Marked
  5. - Severe
Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CTGel Plus BPO Wash CTGel
Hide Arm/Group Description:
BPO Wash in the morning and CTGel in the evening
Soap Free Cleanser in the morning and CTGel in the evening
Overall Number of Participants Analyzed 30 31
Measure Type: Number
Unit of Measure: Participants
Grade 0 22 15
Grade 1 5 12
Grade 2 1 2
Grade 3 0 0
Grade 4 0 0
Grade 5 0 0
Missing 2 2
16.Secondary Outcome
Title Subject Assessment of Burning/Stinging
Hide Description

Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:

0 - None

  1. - Trace
  2. - Mild
  3. - Moderate
  4. - Marked
  5. - Severe
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CTGel Plus BPO Wash CTGel
Hide Arm/Group Description:
BPO Wash in the morning and CTGel in the evening
Soap Free Cleanser in the morning and CTGel in the evening
Overall Number of Participants Analyzed 30 31
Measure Type: Number
Unit of Measure: Participants
Grade 0 23 14
Grade 1 4 15
Grade 2 0 1
Grade 3 0 1
Grade 4 0 0
Grade 5 0 0
Missing 3 0
17.Secondary Outcome
Title Subject Assessment of Itching
Hide Description

Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:

0 - None

  1. - Trace
  2. - Mild
  3. - Moderate
  4. - Marked
  5. - Severe
Time Frame Screening/Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CTGel Plus BPO Wash CTGel
Hide Arm/Group Description:
BPO Wash in the morning and CTGel in the evening
Soap Free Cleanser in the morning and CTGel in the evening
Overall Number of Participants Analyzed 30 31
Measure Type: Number
Unit of Measure: Participants
Grade 0 25 21
Grade 1 3 6
Grade 2 2 2
Grade 3 0 2
Grade 4 0 0
Grade 5 0 0
Missing 0 0
18.Secondary Outcome
Title Subject Assessment of Itching
Hide Description

Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:

0 - None

  1. - Trace
  2. - Mild
  3. - Moderate
  4. - Marked
  5. - Severe
Time Frame Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CTGel Plus BPO Wash CTGel
Hide Arm/Group Description:
BPO Wash in the morning and CTGel in the evening
Soap Free Cleanser in the morning and CTGel in the evening
Overall Number of Participants Analyzed 30 31
Measure Type: Number
Unit of Measure: Participants
Grade 0 13 14
Grade 1 6 9
Grade 2 8 6
Grade 3 2 0
Grade 4 0 0
Grade 5 0 0
Missing 1 2
19.Secondary Outcome
Title Subject Assessment of Itching
Hide Description

Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:

0 - None

  1. - Trace
  2. - Mild
  3. - Moderate
  4. - Marked
  5. - Severe
Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CTGel Plus BPO Wash CTGel
Hide Arm/Group Description:
BPO Wash in the morning and CTGel in the evening
Soap Free Cleanser in the morning and CTGel in the evening
Overall Number of Participants Analyzed 30 31
Measure Type: Number
Unit of Measure: Participants
Grade 0 18 18
Grade 1 6 10
Grade 2 3 1
Grade 3 1 0
Grade 4 0 0
Grade 5 0 0
Missing 2 2
20.Secondary Outcome
Title Subject Assessment of Itching
Hide Description

Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:

0 - None

  1. - Trace
  2. - Mild
  3. - Moderate
  4. - Marked
  5. - Severe
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CTGel Plus BPO Wash CTGel
Hide Arm/Group Description:
BPO Wash in the morning and CTGel in the evening
Soap Free Cleanser in the morning and CTGel in the evening
Overall Number of Participants Analyzed 30 31
Measure Type: Number
Unit of Measure: Participants
Grade 0 18 21
Grade 1 9 8
Grade 2 0 2
Grade 3 0 0
Grade 4 0 0
Grade 5 0 0
Missing 3 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CTGel Plus BPO Wash CTGel
Hide Arm/Group Description BPO Wash in the morning and CTGel in the evening Soap Free Cleanser in the morning and CTGel in the evening
All-Cause Mortality
CTGel Plus BPO Wash CTGel
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
CTGel Plus BPO Wash CTGel
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/31 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
CTGel Plus BPO Wash CTGel
Affected / at Risk (%) Affected / at Risk (%)
Total   1/30 (3.33%)   5/31 (16.13%) 
General disorders     
Application site dryness  0/30 (0.00%)  3/31 (9.68%) 
Infections and infestations     
Nasopharyngitis  1/30 (3.33%)  2/31 (6.45%) 
1
Term from vocabulary, MedDRA (11.0)
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.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier: NCT00891982     History of Changes
Other Study ID Numbers: 114679
First Submitted: April 29, 2009
First Posted: May 1, 2009
Results First Submitted: October 6, 2010
Results First Posted: July 25, 2011
Last Update Posted: May 24, 2017