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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

A Phase 3B, Multicenter, Assessor-Blinded Study of the Tolerability of Clindamycin 1%-Tretinoin 0.025% Gel Used in Conjunction With Benzoyl Peroxide 4% Wash in Subjects With Mild to Moderate Facial Acne Vulgaris

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00891982
Enrollment
60
Registered
2009-05-01
Start date
2009-04-01
Completion date
2009-06-05
Last updated
2017-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acne Vulgaris

Keywords

Acne Vulgaris

Brief summary

The purpose of this study is to evaluate the tolerability of a combined regimen of a topical antibiotic and retinoid and a benzoyl peroxide wash.

Interventions

DRUGCTGel/ BPO Wash

Benzoyl Peroxide (BPO) wash will be used once daily in the morning for 28 days Clindamycin and Tretinoin (CT) gel will be used once daily in the evening for 28 days.

DRUGSoap Free Cleanser and CTGel

Soap Free Cleanser will be used once daily in the morning for 28 days Clindamycin and Tretinoin gel will be used once daily in the evening for 28 days.

Sponsors

GlaxoSmithKline
CollaboratorINDUSTRY
Stiefel, a GSK Company
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
12 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

* Subjects with mild to moderate facial acne vulgaris, with no history of known or suspected hypersensitivity or previous allergic reaction to any of the ingredients of the study products (eg, topical antibiotics, retinoids or benzoyl peroxide), capable of understanding and willing to provide signed and dated written voluntary informed consent and able to complete the study and to comply with study instructions. * Female subjects of childbearing potential must have a negative urine pregnancy test result at baseline and practice a reliable method of contraception throughout the study.

Exclusion criteria

* Use of topical antibiotics on the face within the past 2 weeks or use of systemic antibiotics within the past 4 weeks.

Design outcomes

Primary

MeasureTime frameDescription
Local Tolerability - Skin DrynessScreening/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
Local Tolerability - Skin ScalingScreening/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
Local Tolerability - Erythema (Redness)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

Secondary

MeasureTime frameDescription
Subject Assessment of Burning/StingingScreening/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
Subject Assessment of ItchingScreening/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

Countries

United States

Participant flow

Participants by arm

ArmCount
CTGel Plus BPO Wash
BPO Wash in the morning and CTGel in the evening
30
CTGel
Soap Free Cleanser in the morning and CTGel in the evening
31
Total61

Baseline characteristics

CharacteristicCTGel Plus BPO WashCTGelTotal
Age, Customized
<18 years
16 participants14 participants30 participants
Age, Customized
Between 18 and 45 years
14 participants17 participants31 participants
Ethnicity (NIH/OMB)
Hispanic or Latino
6 Participants5 Participants11 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
24 Participants26 Participants50 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
ISGA
Grade 2
9 participants11 participants20 participants
ISGA
Grade 3
18 participants15 participants33 participants
ISGA
Grade 4
3 participants5 participants8 participants
Race/Ethnicity, Customized
Black or African American
2 Participants3 Participants5 Participants
Race/Ethnicity, Customized
More than one race
4 Participants0 Participants4 Participants
Race/Ethnicity, Customized
White
24 Participants28 Participants52 Participants
Region of Enrollment
United States
30 participants31 participants61 participants
Sex: Female, Male
Female
18 Participants20 Participants38 Participants
Sex: Female, Male
Male
12 Participants11 Participants23 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
1 / 305 / 31
serious
Total, serious adverse events
0 / 300 / 31

Outcome results

Primary

Local Tolerability - Erythema (Redness)

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

ArmMeasureGroupValue (NUMBER)
CTGel Plus BPO WashLocal Tolerability - Erythema (Redness)Grade 25 Participants
CTGel Plus BPO WashLocal Tolerability - Erythema (Redness)Grade 40 Participants
CTGel Plus BPO WashLocal Tolerability - Erythema (Redness)Grade 15 Participants
CTGel Plus BPO WashLocal Tolerability - Erythema (Redness)Grade 50 Participants
CTGel Plus BPO WashLocal Tolerability - Erythema (Redness)Grade 31 Participants
CTGel Plus BPO WashLocal Tolerability - Erythema (Redness)Missing2 Participants
CTGel Plus BPO WashLocal Tolerability - Erythema (Redness)Grade 017 Participants
CTGelLocal Tolerability - Erythema (Redness)Missing2 Participants
CTGelLocal Tolerability - Erythema (Redness)Grade 012 Participants
CTGelLocal Tolerability - Erythema (Redness)Grade 19 Participants
CTGelLocal Tolerability - Erythema (Redness)Grade 26 Participants
CTGelLocal Tolerability - Erythema (Redness)Grade 32 Participants
CTGelLocal Tolerability - Erythema (Redness)Grade 40 Participants
CTGelLocal Tolerability - Erythema (Redness)Grade 50 Participants
Primary

Local Tolerability - Erythema (Redness)

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

ArmMeasureGroupValue (NUMBER)
CTGel Plus BPO WashLocal Tolerability - Erythema (Redness)Grade 34 Participants
CTGel Plus BPO WashLocal Tolerability - Erythema (Redness)Grade 40 Participants
CTGel Plus BPO WashLocal Tolerability - Erythema (Redness)Grade 15 Participants
CTGel Plus BPO WashLocal Tolerability - Erythema (Redness)Grade 50 Participants
CTGel Plus BPO WashLocal Tolerability - Erythema (Redness)Grade 015 Participants
CTGel Plus BPO WashLocal Tolerability - Erythema (Redness)Missing2 Participants
CTGel Plus BPO WashLocal Tolerability - Erythema (Redness)Grade 24 Participants
CTGelLocal Tolerability - Erythema (Redness)Missing0 Participants
CTGelLocal Tolerability - Erythema (Redness)Grade 016 Participants
CTGelLocal Tolerability - Erythema (Redness)Grade 19 Participants
CTGelLocal Tolerability - Erythema (Redness)Grade 32 Participants
CTGelLocal Tolerability - Erythema (Redness)Grade 40 Participants
CTGelLocal Tolerability - Erythema (Redness)Grade 50 Participants
CTGelLocal Tolerability - Erythema (Redness)Grade 24 Participants
Primary

Local Tolerability - Erythema (Redness)

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

ArmMeasureGroupValue (NUMBER)
CTGel Plus BPO WashLocal Tolerability - Erythema (Redness)Grade 14 Participants
CTGel Plus BPO WashLocal Tolerability - Erythema (Redness)Grade 40 Participants
CTGel Plus BPO WashLocal Tolerability - Erythema (Redness)Grade 21 Participants
CTGel Plus BPO WashLocal Tolerability - Erythema (Redness)Grade 50 Participants
CTGel Plus BPO WashLocal Tolerability - Erythema (Redness)Grade 022 Participants
CTGel Plus BPO WashLocal Tolerability - Erythema (Redness)Missing0 Participants
CTGel Plus BPO WashLocal Tolerability - Erythema (Redness)Grade 33 Participants
CTGelLocal Tolerability - Erythema (Redness)Missing0 Participants
CTGelLocal Tolerability - Erythema (Redness)Grade 14 Participants
CTGelLocal Tolerability - Erythema (Redness)Grade 24 Participants
CTGelLocal Tolerability - Erythema (Redness)Grade 31 Participants
CTGelLocal Tolerability - Erythema (Redness)Grade 40 Participants
CTGelLocal Tolerability - Erythema (Redness)Grade 50 Participants
CTGelLocal Tolerability - Erythema (Redness)Grade 022 Participants
Primary

Local Tolerability - Erythema (Redness)

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

ArmMeasureGroupValue (NUMBER)
CTGel Plus BPO WashLocal Tolerability - Erythema (Redness)Grade 28 Participants
CTGel Plus BPO WashLocal Tolerability - Erythema (Redness)Grade 40 Participants
CTGel Plus BPO WashLocal Tolerability - Erythema (Redness)Grade 18 Participants
CTGel Plus BPO WashLocal Tolerability - Erythema (Redness)Grade 50 Participants
CTGel Plus BPO WashLocal Tolerability - Erythema (Redness)Grade 33 Participants
CTGel Plus BPO WashLocal Tolerability - Erythema (Redness)Missing1 Participants
CTGel Plus BPO WashLocal Tolerability - Erythema (Redness)Grade 010 Participants
CTGelLocal Tolerability - Erythema (Redness)Missing1 Participants
CTGelLocal Tolerability - Erythema (Redness)Grade 018 Participants
CTGelLocal Tolerability - Erythema (Redness)Grade 15 Participants
CTGelLocal Tolerability - Erythema (Redness)Grade 22 Participants
CTGelLocal Tolerability - Erythema (Redness)Grade 33 Participants
CTGelLocal Tolerability - Erythema (Redness)Grade 42 Participants
CTGelLocal Tolerability - Erythema (Redness)Grade 50 Participants
Primary

Local Tolerability - Skin Dryness

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

ArmMeasureGroupValue (NUMBER)
CTGel Plus BPO WashLocal Tolerability - Skin DrynessGrade 012 participants
CTGel Plus BPO WashLocal Tolerability - Skin DrynessGrade 25 participants
CTGel Plus BPO WashLocal Tolerability - Skin DrynessGrade 51 participants
CTGel Plus BPO WashLocal Tolerability - Skin DrynessGrade 36 participants
CTGel Plus BPO WashLocal Tolerability - Skin DrynessGrade 15 participants
CTGel Plus BPO WashLocal Tolerability - Skin DrynessGrade 40 participants
CTGel Plus BPO WashLocal Tolerability - Skin DrynessMissing1 participants
CTGelLocal Tolerability - Skin DrynessGrade 41 participants
CTGelLocal Tolerability - Skin DrynessMissing1 participants
CTGelLocal Tolerability - Skin DrynessGrade 50 participants
CTGelLocal Tolerability - Skin DrynessGrade 016 participants
CTGelLocal Tolerability - Skin DrynessGrade 18 participants
CTGelLocal Tolerability - Skin DrynessGrade 25 participants
CTGelLocal Tolerability - Skin DrynessGrade 30 participants
Primary

Local Tolerability - Skin Dryness

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

ArmMeasureGroupValue (NUMBER)
CTGel Plus BPO WashLocal Tolerability - Skin DrynessGrade 30 participants
CTGel Plus BPO WashLocal Tolerability - Skin DrynessGrade 50 participants
CTGel Plus BPO WashLocal Tolerability - Skin DrynessGrade 22 participants
CTGel Plus BPO WashLocal Tolerability - Skin DrynessMissing2 participants
CTGel Plus BPO WashLocal Tolerability - Skin DrynessGrade 019 participants
CTGel Plus BPO WashLocal Tolerability - Skin DrynessGrade 40 participants
CTGel Plus BPO WashLocal Tolerability - Skin DrynessGrade 17 participants
CTGelLocal Tolerability - Skin DrynessGrade 40 participants
CTGelLocal Tolerability - Skin DrynessGrade 30 participants
CTGelLocal Tolerability - Skin DrynessGrade 111 participants
CTGelLocal Tolerability - Skin DrynessGrade 21 participants
CTGelLocal Tolerability - Skin DrynessMissing0 participants
CTGelLocal Tolerability - Skin DrynessGrade 50 participants
CTGelLocal Tolerability - Skin DrynessGrade 019 participants
Primary

Local Tolerability - Skin Dryness

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

ArmMeasureGroupValue (NUMBER)
CTGel Plus BPO WashLocal Tolerability - Skin DrynessGrade 12 participants
CTGel Plus BPO WashLocal Tolerability - Skin DrynessGrade 30 participants
CTGel Plus BPO WashLocal Tolerability - Skin DrynessGrade 028 participants
CTGel Plus BPO WashLocal Tolerability - Skin DrynessGrade 40 participants
CTGel Plus BPO WashLocal Tolerability - Skin DrynessGrade 20 participants
CTGel Plus BPO WashLocal Tolerability - Skin DrynessMissing0 participants
CTGel Plus BPO WashLocal Tolerability - Skin DrynessGrade 50 participants
CTGelLocal Tolerability - Skin DrynessMissing0 participants
CTGelLocal Tolerability - Skin DrynessGrade 50 participants
CTGelLocal Tolerability - Skin DrynessGrade 026 participants
CTGelLocal Tolerability - Skin DrynessGrade 14 participants
CTGelLocal Tolerability - Skin DrynessGrade 21 participants
CTGelLocal Tolerability - Skin DrynessGrade 30 participants
CTGelLocal Tolerability - Skin DrynessGrade 40 participants
Primary

Local Tolerability - Skin Dryness

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

ArmMeasureGroupValue (NUMBER)
CTGel Plus BPO WashLocal Tolerability - Skin DrynessGrade 25 participants
CTGel Plus BPO WashLocal Tolerability - Skin DrynessGrade 17 participants
CTGel Plus BPO WashLocal Tolerability - Skin DrynessGrade 40 participants
CTGel Plus BPO WashLocal Tolerability - Skin DrynessGrade 50 participants
CTGel Plus BPO WashLocal Tolerability - Skin DrynessGrade 31 participants
CTGel Plus BPO WashLocal Tolerability - Skin DrynessMissing2 participants
CTGel Plus BPO WashLocal Tolerability - Skin DrynessGrade 015 participants
CTGelLocal Tolerability - Skin DrynessMissing2 participants
CTGelLocal Tolerability - Skin DrynessGrade 30 participants
CTGelLocal Tolerability - Skin DrynessGrade 40 participants
CTGelLocal Tolerability - Skin DrynessGrade 017 participants
CTGelLocal Tolerability - Skin DrynessGrade 24 participants
CTGelLocal Tolerability - Skin DrynessGrade 50 participants
CTGelLocal Tolerability - Skin DrynessGrade 18 participants
Primary

Local Tolerability - Skin Scaling

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

ArmMeasureGroupValue (NUMBER)
CTGel Plus BPO WashLocal Tolerability - Skin ScalingGrade 15 Participants
CTGel Plus BPO WashLocal Tolerability - Skin ScalingGrade 35 Participants
CTGel Plus BPO WashLocal Tolerability - Skin ScalingGrade 50 Participants
CTGel Plus BPO WashLocal Tolerability - Skin ScalingGrade 41 Participants
CTGel Plus BPO WashLocal Tolerability - Skin ScalingGrade 25 Participants
CTGel Plus BPO WashLocal Tolerability - Skin ScalingMissing1 Participants
CTGel Plus BPO WashLocal Tolerability - Skin ScalingGrade 013 Participants
CTGelLocal Tolerability - Skin ScalingMissing1 Participants
CTGelLocal Tolerability - Skin ScalingGrade 019 Participants
CTGelLocal Tolerability - Skin ScalingGrade 50 Participants
CTGelLocal Tolerability - Skin ScalingGrade 15 Participants
CTGelLocal Tolerability - Skin ScalingGrade 23 Participants
CTGelLocal Tolerability - Skin ScalingGrade 32 Participants
CTGelLocal Tolerability - Skin ScalingGrade 41 Participants
Primary

Local Tolerability - Skin Scaling

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

ArmMeasureGroupValue (NUMBER)
CTGel Plus BPO WashLocal Tolerability - Skin ScalingMissing2 Participants
CTGel Plus BPO WashLocal Tolerability - Skin ScalingGrade 30 Participants
CTGel Plus BPO WashLocal Tolerability - Skin ScalingGrade 16 Participants
CTGel Plus BPO WashLocal Tolerability - Skin ScalingGrade 40 Participants
CTGel Plus BPO WashLocal Tolerability - Skin ScalingGrade 020 Participants
CTGel Plus BPO WashLocal Tolerability - Skin ScalingGrade 50 Participants
CTGel Plus BPO WashLocal Tolerability - Skin ScalingGrade 22 Participants
CTGelLocal Tolerability - Skin ScalingMissing0 Participants
CTGelLocal Tolerability - Skin ScalingGrade 025 Participants
CTGelLocal Tolerability - Skin ScalingGrade 15 Participants
CTGelLocal Tolerability - Skin ScalingGrade 21 Participants
CTGelLocal Tolerability - Skin ScalingGrade 30 Participants
CTGelLocal Tolerability - Skin ScalingGrade 40 Participants
CTGelLocal Tolerability - Skin ScalingGrade 50 Participants
Primary

Local Tolerability - Skin Scaling

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

ArmMeasureGroupValue (NUMBER)
CTGel Plus BPO WashLocal Tolerability - Skin ScalingGrade 50 Participants
CTGel Plus BPO WashLocal Tolerability - Skin ScalingGrade 20 Participants
CTGel Plus BPO WashLocal Tolerability - Skin ScalingMissing0 Participants
CTGel Plus BPO WashLocal Tolerability - Skin ScalingGrade 30 Participants
CTGel Plus BPO WashLocal Tolerability - Skin ScalingGrade 11 Participants
CTGel Plus BPO WashLocal Tolerability - Skin ScalingGrade 40 Participants
CTGel Plus BPO WashLocal Tolerability - Skin ScalingGrade 029 Participants
CTGelLocal Tolerability - Skin ScalingGrade 50 Participants
CTGelLocal Tolerability - Skin ScalingGrade 40 Participants
CTGelLocal Tolerability - Skin ScalingMissing0 Participants
CTGelLocal Tolerability - Skin ScalingGrade 028 Participants
CTGelLocal Tolerability - Skin ScalingGrade 12 Participants
CTGelLocal Tolerability - Skin ScalingGrade 21 Participants
CTGelLocal Tolerability - Skin ScalingGrade 30 Participants
Primary

Local Tolerability - Skin Scaling

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

ArmMeasureGroupValue (NUMBER)
CTGel Plus BPO WashLocal Tolerability - Skin ScalingGrade 50 Participants
CTGel Plus BPO WashLocal Tolerability - Skin ScalingMissing2 Participants
CTGel Plus BPO WashLocal Tolerability - Skin ScalingGrade 017 Participants
CTGel Plus BPO WashLocal Tolerability - Skin ScalingGrade 16 Participants
CTGel Plus BPO WashLocal Tolerability - Skin ScalingGrade 24 Participants
CTGel Plus BPO WashLocal Tolerability - Skin ScalingGrade 31 Participants
CTGel Plus BPO WashLocal Tolerability - Skin ScalingGrade 40 Participants
CTGelLocal Tolerability - Skin ScalingGrade 50 Participants
CTGelLocal Tolerability - Skin ScalingGrade 24 Participants
CTGelLocal Tolerability - Skin ScalingMissing2 Participants
CTGelLocal Tolerability - Skin ScalingGrade 40 Participants
CTGelLocal Tolerability - Skin ScalingGrade 019 Participants
CTGelLocal Tolerability - Skin ScalingGrade 30 Participants
CTGelLocal Tolerability - Skin ScalingGrade 16 Participants
Secondary

Subject Assessment of Burning/Stinging

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

ArmMeasureGroupValue (NUMBER)
CTGel Plus BPO WashSubject Assessment of Burning/StingingGrade 50 Participants
CTGel Plus BPO WashSubject Assessment of Burning/StingingGrade 15 Participants
CTGel Plus BPO WashSubject Assessment of Burning/StingingGrade 40 Participants
CTGel Plus BPO WashSubject Assessment of Burning/StingingGrade 21 Participants
CTGel Plus BPO WashSubject Assessment of Burning/StingingGrade 022 Participants
CTGel Plus BPO WashSubject Assessment of Burning/StingingMissing2 Participants
CTGel Plus BPO WashSubject Assessment of Burning/StingingGrade 30 Participants
CTGelSubject Assessment of Burning/StingingMissing2 Participants
CTGelSubject Assessment of Burning/StingingGrade 30 Participants
CTGelSubject Assessment of Burning/StingingGrade 40 Participants
CTGelSubject Assessment of Burning/StingingGrade 50 Participants
CTGelSubject Assessment of Burning/StingingGrade 015 Participants
CTGelSubject Assessment of Burning/StingingGrade 112 Participants
CTGelSubject Assessment of Burning/StingingGrade 22 Participants
Secondary

Subject Assessment of Burning/Stinging

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

ArmMeasureGroupValue (NUMBER)
CTGel Plus BPO WashSubject Assessment of Burning/StingingGrade 20 Participants
CTGel Plus BPO WashSubject Assessment of Burning/StingingGrade 40 Participants
CTGel Plus BPO WashSubject Assessment of Burning/StingingGrade 14 Participants
CTGel Plus BPO WashSubject Assessment of Burning/StingingGrade 50 Participants
CTGel Plus BPO WashSubject Assessment of Burning/StingingGrade 30 Participants
CTGel Plus BPO WashSubject Assessment of Burning/StingingMissing3 Participants
CTGel Plus BPO WashSubject Assessment of Burning/StingingGrade 023 Participants
CTGelSubject Assessment of Burning/StingingMissing0 Participants
CTGelSubject Assessment of Burning/StingingGrade 014 Participants
CTGelSubject Assessment of Burning/StingingGrade 115 Participants
CTGelSubject Assessment of Burning/StingingGrade 21 Participants
CTGelSubject Assessment of Burning/StingingGrade 31 Participants
CTGelSubject Assessment of Burning/StingingGrade 40 Participants
CTGelSubject Assessment of Burning/StingingGrade 50 Participants
Secondary

Subject Assessment of Burning/Stinging

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

ArmMeasureGroupValue (NUMBER)
CTGel Plus BPO WashSubject Assessment of Burning/StingingGrade 12 Participants
CTGel Plus BPO WashSubject Assessment of Burning/StingingGrade 30 Participants
CTGel Plus BPO WashSubject Assessment of Burning/StingingGrade 027 Participants
CTGel Plus BPO WashSubject Assessment of Burning/StingingGrade 40 Participants
CTGel Plus BPO WashSubject Assessment of Burning/StingingGrade 21 Participants
CTGel Plus BPO WashSubject Assessment of Burning/StingingGrade 50 Participants
CTGel Plus BPO WashSubject Assessment of Burning/StingingMissing0 Participants
CTGelSubject Assessment of Burning/StingingGrade 50 Participants
CTGelSubject Assessment of Burning/StingingMissing0 Participants
CTGelSubject Assessment of Burning/StingingGrade 026 Participants
CTGelSubject Assessment of Burning/StingingGrade 11 Participants
CTGelSubject Assessment of Burning/StingingGrade 23 Participants
CTGelSubject Assessment of Burning/StingingGrade 30 Participants
CTGelSubject Assessment of Burning/StingingGrade 41 Participants
Secondary

Subject Assessment of Burning/Stinging

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

ArmMeasureGroupValue (NUMBER)
CTGel Plus BPO WashSubject Assessment of Burning/StingingGrade 23 Participants
CTGel Plus BPO WashSubject Assessment of Burning/StingingGrade 40 Participants
CTGel Plus BPO WashSubject Assessment of Burning/StingingGrade 17 Participants
CTGel Plus BPO WashSubject Assessment of Burning/StingingGrade 50 Participants
CTGel Plus BPO WashSubject Assessment of Burning/StingingGrade 35 Participants
CTGel Plus BPO WashSubject Assessment of Burning/StingingMissing1 Participants
CTGel Plus BPO WashSubject Assessment of Burning/StingingGrade 014 Participants
CTGelSubject Assessment of Burning/StingingMissing2 Participants
CTGelSubject Assessment of Burning/StingingGrade 015 Participants
CTGelSubject Assessment of Burning/StingingGrade 18 Participants
CTGelSubject Assessment of Burning/StingingGrade 23 Participants
CTGelSubject Assessment of Burning/StingingGrade 32 Participants
CTGelSubject Assessment of Burning/StingingGrade 40 Participants
CTGelSubject Assessment of Burning/StingingGrade 51 Participants
Secondary

Subject Assessment of Itching

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

ArmMeasureGroupValue (NUMBER)
CTGel Plus BPO WashSubject Assessment of ItchingGrade 22 Participants
CTGel Plus BPO WashSubject Assessment of ItchingGrade 40 Participants
CTGel Plus BPO WashSubject Assessment of ItchingGrade 13 Participants
CTGel Plus BPO WashSubject Assessment of ItchingGrade 50 Participants
CTGel Plus BPO WashSubject Assessment of ItchingGrade 30 Participants
CTGel Plus BPO WashSubject Assessment of ItchingMissing0 Participants
CTGel Plus BPO WashSubject Assessment of ItchingGrade 025 Participants
CTGelSubject Assessment of ItchingMissing0 Participants
CTGelSubject Assessment of ItchingGrade 021 Participants
CTGelSubject Assessment of ItchingGrade 16 Participants
CTGelSubject Assessment of ItchingGrade 22 Participants
CTGelSubject Assessment of ItchingGrade 32 Participants
CTGelSubject Assessment of ItchingGrade 40 Participants
CTGelSubject Assessment of ItchingGrade 50 Participants
Secondary

Subject Assessment of Itching

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

ArmMeasureGroupValue (NUMBER)
CTGel Plus BPO WashSubject Assessment of ItchingGrade 28 Participants
CTGel Plus BPO WashSubject Assessment of ItchingGrade 40 Participants
CTGel Plus BPO WashSubject Assessment of ItchingGrade 16 Participants
CTGel Plus BPO WashSubject Assessment of ItchingGrade 50 Participants
CTGel Plus BPO WashSubject Assessment of ItchingGrade 32 Participants
CTGel Plus BPO WashSubject Assessment of ItchingMissing1 Participants
CTGel Plus BPO WashSubject Assessment of ItchingGrade 013 Participants
CTGelSubject Assessment of ItchingMissing2 Participants
CTGelSubject Assessment of ItchingGrade 014 Participants
CTGelSubject Assessment of ItchingGrade 19 Participants
CTGelSubject Assessment of ItchingGrade 26 Participants
CTGelSubject Assessment of ItchingGrade 30 Participants
CTGelSubject Assessment of ItchingGrade 40 Participants
CTGelSubject Assessment of ItchingGrade 50 Participants
Secondary

Subject Assessment of Itching

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

ArmMeasureGroupValue (NUMBER)
CTGel Plus BPO WashSubject Assessment of ItchingGrade 23 Participants
CTGel Plus BPO WashSubject Assessment of ItchingGrade 40 Participants
CTGel Plus BPO WashSubject Assessment of ItchingGrade 16 Participants
CTGel Plus BPO WashSubject Assessment of ItchingGrade 50 Participants
CTGel Plus BPO WashSubject Assessment of ItchingGrade 31 Participants
CTGel Plus BPO WashSubject Assessment of ItchingMissing2 Participants
CTGel Plus BPO WashSubject Assessment of ItchingGrade 018 Participants
CTGelSubject Assessment of ItchingMissing2 Participants
CTGelSubject Assessment of ItchingGrade 018 Participants
CTGelSubject Assessment of ItchingGrade 110 Participants
CTGelSubject Assessment of ItchingGrade 21 Participants
CTGelSubject Assessment of ItchingGrade 30 Participants
CTGelSubject Assessment of ItchingGrade 40 Participants
CTGelSubject Assessment of ItchingGrade 50 Participants
Secondary

Subject Assessment of Itching

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

ArmMeasureGroupValue (NUMBER)
CTGel Plus BPO WashSubject Assessment of ItchingGrade 018 Participants
CTGel Plus BPO WashSubject Assessment of ItchingGrade 40 Participants
CTGel Plus BPO WashSubject Assessment of ItchingGrade 30 Participants
CTGel Plus BPO WashSubject Assessment of ItchingGrade 50 Participants
CTGel Plus BPO WashSubject Assessment of ItchingGrade 19 Participants
CTGel Plus BPO WashSubject Assessment of ItchingMissing3 Participants
CTGel Plus BPO WashSubject Assessment of ItchingGrade 20 Participants
CTGelSubject Assessment of ItchingMissing0 Participants
CTGelSubject Assessment of ItchingGrade 22 Participants
CTGelSubject Assessment of ItchingGrade 30 Participants
CTGelSubject Assessment of ItchingGrade 021 Participants
CTGelSubject Assessment of ItchingGrade 18 Participants
CTGelSubject Assessment of ItchingGrade 40 Participants
CTGelSubject Assessment of ItchingGrade 50 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026