Trial Outcomes & Findings for A Clinical Study to Evaluate the Tolerability of a Topical Antibiotic and Retinoid Used in a Combined Regimen With a BPO Wash (NCT NCT00891982)
NCT ID: NCT00891982
Last Updated: 2017-05-24
Results Overview
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
COMPLETED
PHASE3
60 participants
Screening/baseline
2017-05-24
Participant Flow
Participant milestones
| Measure |
CTGel Plus BPO Wash
BPO Wash in the morning and CTGel in the evening
|
CTGel
Soap Free Cleanser in the morning and CTGel in the evening
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
31
|
|
Overall Study
COMPLETED
|
28
|
30
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Clinical Study to Evaluate the Tolerability of a Topical Antibiotic and Retinoid Used in a Combined Regimen With a BPO Wash
Baseline characteristics by cohort
| Measure |
CTGel Plus BPO Wash
n=30 Participants
BPO Wash in the morning and CTGel in the evening
|
CTGel
n=31 Participants
Soap Free Cleanser in the morning and CTGel in the evening
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<18 years
|
16 participants
n=99 Participants
|
14 participants
n=107 Participants
|
30 participants
n=206 Participants
|
|
Age, Customized
Between 18 and 45 years
|
14 participants
n=99 Participants
|
17 participants
n=107 Participants
|
31 participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
24 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
4 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=99 Participants
|
31 participants
n=107 Participants
|
61 participants
n=206 Participants
|
|
ISGA
Grade 2
|
9 participants
n=99 Participants
|
11 participants
n=107 Participants
|
20 participants
n=206 Participants
|
|
ISGA
Grade 3
|
18 participants
n=99 Participants
|
15 participants
n=107 Participants
|
33 participants
n=206 Participants
|
|
ISGA
Grade 4
|
3 participants
n=99 Participants
|
5 participants
n=107 Participants
|
8 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Screening/baselineLocal 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
Outcome measures
| Measure |
CTGel Plus BPO Wash
n=30 Participants
BPO Wash in the morning and CTGel in the evening
|
CTGel
n=31 Participants
Soap Free Cleanser in the morning and CTGel in the evening
|
|---|---|---|
|
Local Tolerability - Skin Dryness
Grade 0
|
28 participants
|
26 participants
|
|
Local Tolerability - Skin Dryness
Grade 1
|
2 participants
|
4 participants
|
|
Local Tolerability - Skin Dryness
Grade 2
|
0 participants
|
1 participants
|
|
Local Tolerability - Skin Dryness
Grade 3
|
0 participants
|
0 participants
|
|
Local Tolerability - Skin Dryness
Grade 4
|
0 participants
|
0 participants
|
|
Local Tolerability - Skin Dryness
Grade 5
|
0 participants
|
0 participants
|
|
Local Tolerability - Skin Dryness
Missing
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Week 1Local 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
Outcome measures
| Measure |
CTGel Plus BPO Wash
n=30 Participants
BPO Wash in the morning and CTGel in the evening
|
CTGel
n=31 Participants
Soap Free Cleanser in the morning and CTGel in the evening
|
|---|---|---|
|
Local Tolerability - Skin Dryness
Missing
|
1 participants
|
1 participants
|
|
Local Tolerability - Skin Dryness
Grade 0
|
12 participants
|
16 participants
|
|
Local Tolerability - Skin Dryness
Grade 1
|
5 participants
|
8 participants
|
|
Local Tolerability - Skin Dryness
Grade 2
|
5 participants
|
5 participants
|
|
Local Tolerability - Skin Dryness
Grade 3
|
6 participants
|
0 participants
|
|
Local Tolerability - Skin Dryness
Grade 4
|
0 participants
|
1 participants
|
|
Local Tolerability - Skin Dryness
Grade 5
|
1 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Week 2Local 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
Outcome measures
| Measure |
CTGel Plus BPO Wash
n=30 Participants
BPO Wash in the morning and CTGel in the evening
|
CTGel
n=31 Participants
Soap Free Cleanser in the morning and CTGel in the evening
|
|---|---|---|
|
Local Tolerability - Skin Dryness
Grade 0
|
15 participants
|
17 participants
|
|
Local Tolerability - Skin Dryness
Grade 1
|
7 participants
|
8 participants
|
|
Local Tolerability - Skin Dryness
Grade 2
|
5 participants
|
4 participants
|
|
Local Tolerability - Skin Dryness
Grade 3
|
1 participants
|
0 participants
|
|
Local Tolerability - Skin Dryness
Grade 4
|
0 participants
|
0 participants
|
|
Local Tolerability - Skin Dryness
Grade 5
|
0 participants
|
0 participants
|
|
Local Tolerability - Skin Dryness
Missing
|
2 participants
|
2 participants
|
PRIMARY outcome
Timeframe: Week 4Local 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
Outcome measures
| Measure |
CTGel Plus BPO Wash
n=30 Participants
BPO Wash in the morning and CTGel in the evening
|
CTGel
n=31 Participants
Soap Free Cleanser in the morning and CTGel in the evening
|
|---|---|---|
|
Local Tolerability - Skin Dryness
Grade 0
|
19 participants
|
19 participants
|
|
Local Tolerability - Skin Dryness
Grade 1
|
7 participants
|
11 participants
|
|
Local Tolerability - Skin Dryness
Grade 2
|
2 participants
|
1 participants
|
|
Local Tolerability - Skin Dryness
Grade 3
|
0 participants
|
0 participants
|
|
Local Tolerability - Skin Dryness
Grade 4
|
0 participants
|
0 participants
|
|
Local Tolerability - Skin Dryness
Grade 5
|
0 participants
|
0 participants
|
|
Local Tolerability - Skin Dryness
Missing
|
2 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Screening/baselineLocal 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
Outcome measures
| Measure |
CTGel Plus BPO Wash
n=30 Participants
BPO Wash in the morning and CTGel in the evening
|
CTGel
n=31 Participants
Soap Free Cleanser in the morning and CTGel in the evening
|
|---|---|---|
|
Local Tolerability - Skin Scaling
Grade 0
|
29 Participants
|
28 Participants
|
|
Local Tolerability - Skin Scaling
Grade 1
|
1 Participants
|
2 Participants
|
|
Local Tolerability - Skin Scaling
Grade 2
|
0 Participants
|
1 Participants
|
|
Local Tolerability - Skin Scaling
Grade 3
|
0 Participants
|
0 Participants
|
|
Local Tolerability - Skin Scaling
Grade 4
|
0 Participants
|
0 Participants
|
|
Local Tolerability - Skin Scaling
Grade 5
|
0 Participants
|
0 Participants
|
|
Local Tolerability - Skin Scaling
Missing
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Week 1Local 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
Outcome measures
| Measure |
CTGel Plus BPO Wash
n=30 Participants
BPO Wash in the morning and CTGel in the evening
|
CTGel
n=31 Participants
Soap Free Cleanser in the morning and CTGel in the evening
|
|---|---|---|
|
Local Tolerability - Skin Scaling
Grade 0
|
13 Participants
|
19 Participants
|
|
Local Tolerability - Skin Scaling
Grade 1
|
5 Participants
|
5 Participants
|
|
Local Tolerability - Skin Scaling
Grade 2
|
5 Participants
|
3 Participants
|
|
Local Tolerability - Skin Scaling
Grade 3
|
5 Participants
|
2 Participants
|
|
Local Tolerability - Skin Scaling
Grade 4
|
1 Participants
|
1 Participants
|
|
Local Tolerability - Skin Scaling
Grade 5
|
0 Participants
|
0 Participants
|
|
Local Tolerability - Skin Scaling
Missing
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Week 2Local 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
Outcome measures
| Measure |
CTGel Plus BPO Wash
n=30 Participants
BPO Wash in the morning and CTGel in the evening
|
CTGel
n=31 Participants
Soap Free Cleanser in the morning and CTGel in the evening
|
|---|---|---|
|
Local Tolerability - Skin Scaling
Grade 0
|
17 Participants
|
19 Participants
|
|
Local Tolerability - Skin Scaling
Grade 1
|
6 Participants
|
6 Participants
|
|
Local Tolerability - Skin Scaling
Grade 2
|
4 Participants
|
4 Participants
|
|
Local Tolerability - Skin Scaling
Grade 3
|
1 Participants
|
0 Participants
|
|
Local Tolerability - Skin Scaling
Grade 4
|
0 Participants
|
0 Participants
|
|
Local Tolerability - Skin Scaling
Grade 5
|
0 Participants
|
0 Participants
|
|
Local Tolerability - Skin Scaling
Missing
|
2 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Week 4Local 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
Outcome measures
| Measure |
CTGel Plus BPO Wash
n=30 Participants
BPO Wash in the morning and CTGel in the evening
|
CTGel
n=31 Participants
Soap Free Cleanser in the morning and CTGel in the evening
|
|---|---|---|
|
Local Tolerability - Skin Scaling
Grade 0
|
20 Participants
|
25 Participants
|
|
Local Tolerability - Skin Scaling
Grade 1
|
6 Participants
|
5 Participants
|
|
Local Tolerability - Skin Scaling
Grade 2
|
2 Participants
|
1 Participants
|
|
Local Tolerability - Skin Scaling
Grade 3
|
0 Participants
|
0 Participants
|
|
Local Tolerability - Skin Scaling
Grade 4
|
0 Participants
|
0 Participants
|
|
Local Tolerability - Skin Scaling
Grade 5
|
0 Participants
|
0 Participants
|
|
Local Tolerability - Skin Scaling
Missing
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Screening/baselineLocal 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
Outcome measures
| Measure |
CTGel Plus BPO Wash
n=30 Participants
BPO Wash in the morning and CTGel in the evening
|
CTGel
n=31 Participants
Soap Free Cleanser in the morning and CTGel in the evening
|
|---|---|---|
|
Local Tolerability - Erythema (Redness)
Grade 0
|
22 Participants
|
22 Participants
|
|
Local Tolerability - Erythema (Redness)
Grade 1
|
4 Participants
|
4 Participants
|
|
Local Tolerability - Erythema (Redness)
Grade 2
|
1 Participants
|
4 Participants
|
|
Local Tolerability - Erythema (Redness)
Grade 3
|
3 Participants
|
1 Participants
|
|
Local Tolerability - Erythema (Redness)
Grade 4
|
0 Participants
|
0 Participants
|
|
Local Tolerability - Erythema (Redness)
Grade 5
|
0 Participants
|
0 Participants
|
|
Local Tolerability - Erythema (Redness)
Missing
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Week 1Local 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
Outcome measures
| Measure |
CTGel Plus BPO Wash
n=30 Participants
BPO Wash in the morning and CTGel in the evening
|
CTGel
n=31 Participants
Soap Free Cleanser in the morning and CTGel in the evening
|
|---|---|---|
|
Local Tolerability - Erythema (Redness)
Grade 0
|
10 Participants
|
18 Participants
|
|
Local Tolerability - Erythema (Redness)
Grade 1
|
8 Participants
|
5 Participants
|
|
Local Tolerability - Erythema (Redness)
Grade 2
|
8 Participants
|
2 Participants
|
|
Local Tolerability - Erythema (Redness)
Grade 3
|
3 Participants
|
3 Participants
|
|
Local Tolerability - Erythema (Redness)
Grade 4
|
0 Participants
|
2 Participants
|
|
Local Tolerability - Erythema (Redness)
Grade 5
|
0 Participants
|
0 Participants
|
|
Local Tolerability - Erythema (Redness)
Missing
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Week 2Local 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
Outcome measures
| Measure |
CTGel Plus BPO Wash
n=30 Participants
BPO Wash in the morning and CTGel in the evening
|
CTGel
n=31 Participants
Soap Free Cleanser in the morning and CTGel in the evening
|
|---|---|---|
|
Local Tolerability - Erythema (Redness)
Grade 0
|
17 Participants
|
12 Participants
|
|
Local Tolerability - Erythema (Redness)
Grade 1
|
5 Participants
|
9 Participants
|
|
Local Tolerability - Erythema (Redness)
Grade 2
|
5 Participants
|
6 Participants
|
|
Local Tolerability - Erythema (Redness)
Grade 3
|
1 Participants
|
2 Participants
|
|
Local Tolerability - Erythema (Redness)
Grade 4
|
0 Participants
|
0 Participants
|
|
Local Tolerability - Erythema (Redness)
Grade 5
|
0 Participants
|
0 Participants
|
|
Local Tolerability - Erythema (Redness)
Missing
|
2 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Week 4Local 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
Outcome measures
| Measure |
CTGel Plus BPO Wash
n=30 Participants
BPO Wash in the morning and CTGel in the evening
|
CTGel
n=31 Participants
Soap Free Cleanser in the morning and CTGel in the evening
|
|---|---|---|
|
Local Tolerability - Erythema (Redness)
Grade 0
|
15 Participants
|
16 Participants
|
|
Local Tolerability - Erythema (Redness)
Grade 1
|
5 Participants
|
9 Participants
|
|
Local Tolerability - Erythema (Redness)
Grade 2
|
4 Participants
|
4 Participants
|
|
Local Tolerability - Erythema (Redness)
Grade 3
|
4 Participants
|
2 Participants
|
|
Local Tolerability - Erythema (Redness)
Grade 4
|
0 Participants
|
0 Participants
|
|
Local Tolerability - Erythema (Redness)
Grade 5
|
0 Participants
|
0 Participants
|
|
Local Tolerability - Erythema (Redness)
Missing
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Screening/baselineEach 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
Outcome measures
| Measure |
CTGel Plus BPO Wash
n=30 Participants
BPO Wash in the morning and CTGel in the evening
|
CTGel
n=31 Participants
Soap Free Cleanser in the morning and CTGel in the evening
|
|---|---|---|
|
Subject Assessment of Burning/Stinging
Grade 0
|
27 Participants
|
26 Participants
|
|
Subject Assessment of Burning/Stinging
Grade 1
|
2 Participants
|
1 Participants
|
|
Subject Assessment of Burning/Stinging
Grade 2
|
1 Participants
|
3 Participants
|
|
Subject Assessment of Burning/Stinging
Grade 3
|
0 Participants
|
0 Participants
|
|
Subject Assessment of Burning/Stinging
Grade 4
|
0 Participants
|
1 Participants
|
|
Subject Assessment of Burning/Stinging
Grade 5
|
0 Participants
|
0 Participants
|
|
Subject Assessment of Burning/Stinging
Missing
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 1Each 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
Outcome measures
| Measure |
CTGel Plus BPO Wash
n=30 Participants
BPO Wash in the morning and CTGel in the evening
|
CTGel
n=31 Participants
Soap Free Cleanser in the morning and CTGel in the evening
|
|---|---|---|
|
Subject Assessment of Burning/Stinging
Grade 0
|
14 Participants
|
15 Participants
|
|
Subject Assessment of Burning/Stinging
Grade 1
|
7 Participants
|
8 Participants
|
|
Subject Assessment of Burning/Stinging
Grade 2
|
3 Participants
|
3 Participants
|
|
Subject Assessment of Burning/Stinging
Grade 3
|
5 Participants
|
2 Participants
|
|
Subject Assessment of Burning/Stinging
Grade 4
|
0 Participants
|
0 Participants
|
|
Subject Assessment of Burning/Stinging
Grade 5
|
0 Participants
|
1 Participants
|
|
Subject Assessment of Burning/Stinging
Missing
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Week 2Each 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
Outcome measures
| Measure |
CTGel Plus BPO Wash
n=30 Participants
BPO Wash in the morning and CTGel in the evening
|
CTGel
n=31 Participants
Soap Free Cleanser in the morning and CTGel in the evening
|
|---|---|---|
|
Subject Assessment of Burning/Stinging
Grade 0
|
22 Participants
|
15 Participants
|
|
Subject Assessment of Burning/Stinging
Grade 1
|
5 Participants
|
12 Participants
|
|
Subject Assessment of Burning/Stinging
Grade 2
|
1 Participants
|
2 Participants
|
|
Subject Assessment of Burning/Stinging
Grade 3
|
0 Participants
|
0 Participants
|
|
Subject Assessment of Burning/Stinging
Grade 4
|
0 Participants
|
0 Participants
|
|
Subject Assessment of Burning/Stinging
Grade 5
|
0 Participants
|
0 Participants
|
|
Subject Assessment of Burning/Stinging
Missing
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Week 4Each 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
Outcome measures
| Measure |
CTGel Plus BPO Wash
n=30 Participants
BPO Wash in the morning and CTGel in the evening
|
CTGel
n=31 Participants
Soap Free Cleanser in the morning and CTGel in the evening
|
|---|---|---|
|
Subject Assessment of Burning/Stinging
Grade 0
|
23 Participants
|
14 Participants
|
|
Subject Assessment of Burning/Stinging
Grade 1
|
4 Participants
|
15 Participants
|
|
Subject Assessment of Burning/Stinging
Grade 2
|
0 Participants
|
1 Participants
|
|
Subject Assessment of Burning/Stinging
Grade 3
|
0 Participants
|
1 Participants
|
|
Subject Assessment of Burning/Stinging
Grade 4
|
0 Participants
|
0 Participants
|
|
Subject Assessment of Burning/Stinging
Grade 5
|
0 Participants
|
0 Participants
|
|
Subject Assessment of Burning/Stinging
Missing
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Screening/BaselineEach 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
Outcome measures
| Measure |
CTGel Plus BPO Wash
n=30 Participants
BPO Wash in the morning and CTGel in the evening
|
CTGel
n=31 Participants
Soap Free Cleanser in the morning and CTGel in the evening
|
|---|---|---|
|
Subject Assessment of Itching
Grade 0
|
25 Participants
|
21 Participants
|
|
Subject Assessment of Itching
Grade 1
|
3 Participants
|
6 Participants
|
|
Subject Assessment of Itching
Grade 2
|
2 Participants
|
2 Participants
|
|
Subject Assessment of Itching
Grade 3
|
0 Participants
|
2 Participants
|
|
Subject Assessment of Itching
Grade 4
|
0 Participants
|
0 Participants
|
|
Subject Assessment of Itching
Grade 5
|
0 Participants
|
0 Participants
|
|
Subject Assessment of Itching
Missing
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 1Each 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
Outcome measures
| Measure |
CTGel Plus BPO Wash
n=30 Participants
BPO Wash in the morning and CTGel in the evening
|
CTGel
n=31 Participants
Soap Free Cleanser in the morning and CTGel in the evening
|
|---|---|---|
|
Subject Assessment of Itching
Grade 0
|
13 Participants
|
14 Participants
|
|
Subject Assessment of Itching
Grade 1
|
6 Participants
|
9 Participants
|
|
Subject Assessment of Itching
Grade 2
|
8 Participants
|
6 Participants
|
|
Subject Assessment of Itching
Grade 3
|
2 Participants
|
0 Participants
|
|
Subject Assessment of Itching
Grade 4
|
0 Participants
|
0 Participants
|
|
Subject Assessment of Itching
Grade 5
|
0 Participants
|
0 Participants
|
|
Subject Assessment of Itching
Missing
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Week 2Each 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
Outcome measures
| Measure |
CTGel Plus BPO Wash
n=30 Participants
BPO Wash in the morning and CTGel in the evening
|
CTGel
n=31 Participants
Soap Free Cleanser in the morning and CTGel in the evening
|
|---|---|---|
|
Subject Assessment of Itching
Grade 0
|
18 Participants
|
18 Participants
|
|
Subject Assessment of Itching
Grade 1
|
6 Participants
|
10 Participants
|
|
Subject Assessment of Itching
Grade 2
|
3 Participants
|
1 Participants
|
|
Subject Assessment of Itching
Grade 3
|
1 Participants
|
0 Participants
|
|
Subject Assessment of Itching
Grade 4
|
0 Participants
|
0 Participants
|
|
Subject Assessment of Itching
Grade 5
|
0 Participants
|
0 Participants
|
|
Subject Assessment of Itching
Missing
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Week 4Each 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
Outcome measures
| Measure |
CTGel Plus BPO Wash
n=30 Participants
BPO Wash in the morning and CTGel in the evening
|
CTGel
n=31 Participants
Soap Free Cleanser in the morning and CTGel in the evening
|
|---|---|---|
|
Subject Assessment of Itching
Grade 0
|
18 Participants
|
21 Participants
|
|
Subject Assessment of Itching
Grade 1
|
9 Participants
|
8 Participants
|
|
Subject Assessment of Itching
Grade 2
|
0 Participants
|
2 Participants
|
|
Subject Assessment of Itching
Grade 3
|
0 Participants
|
0 Participants
|
|
Subject Assessment of Itching
Grade 4
|
0 Participants
|
0 Participants
|
|
Subject Assessment of Itching
Grade 5
|
0 Participants
|
0 Participants
|
|
Subject Assessment of Itching
Missing
|
3 Participants
|
0 Participants
|
Adverse Events
CTGel Plus BPO Wash
CTGel
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CTGel Plus BPO Wash
n=30 participants at risk
BPO Wash in the morning and CTGel in the evening
|
CTGel
n=31 participants at risk
Soap Free Cleanser in the morning and CTGel in the evening
|
|---|---|---|
|
General disorders
Application site dryness
|
0.00%
0/30
|
9.7%
3/31
|
|
Infections and infestations
Nasopharyngitis
|
3.3%
1/30
|
6.5%
2/31
|
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER