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CTGel/ BPO Wash

Phase 3

Acne Vulgaris | Small molecule | Dermatology |GSK plc|Trials Updated: May 24, 2017

CTGel/ BPO Wash development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since May 2001

CTGel/ BPO Wash target and mechanism

ModalitySmall molecule

Also known as Veltin

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

CTGel/ BPO Wash clinical trials

CTGel/ BPO Wash · 1 trial · 1 indication

Phase 3 1
NCT00891982A Clinical Study to Evaluate the Tolerability of a Topical Antibiotic and Retinoid Used in a Combined Regimen With a BPO WashAcne Vulgaris
COMPLETED60 Analytics
PHASE3COMPLETED
A Clinical Study to Evaluate the Tolerability of a Topical Antibiotic and Retinoid Used in a Combined Regimen With a BPO Wash
Acne VulgarisUnlock trial analytics

Study Endpoints

Primary Endpoints

Local Tolerability - Skin Dryness
Screening/baseline

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

Local Tolerability - Skin Scaling
Screening/baseline

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

Local Tolerability - Erythema (Redness)
Screening/baseline

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

Secondary Endpoints

Subject Assessment of Burning/Stinging
Screening/baseline
Subject Assessment of Itching
Screening/Baseline
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
CTGel plus BPO washEXPERIMENTALBenzoyl peroxide (BPO) Wash in the morning and CTGel in the evening
CTGelACTIVE_COMPARATORSoap Free Cleanser in the morning and CTGel in the evening

Interventions

NameTypeDescription
CTGel/ BPO WashDRUGBenzoyl 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.
Soap Free Cleanser and CTGelDRUGSoap 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.
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Eligibility Criteria

Age Range12 Years to 45 Years
SexALL
Healthy VolunteersNo
Study Sites5

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 will...

Countries:United States
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Frequently asked questions about CTGel/ BPO Wash

What is CTGel/ BPO Wash?

CTGel/ BPO Wash is an investigational topical combination regimen being developed by GSK plc for acne vulgaris. It pairs a topical antibiotic and retinoid gel with a benzoyl peroxide wash. It is a small molecule dermatology asset and has been studied in a Phase 3 clinical trial.

What is CTGel/ BPO Wash used for?

CTGel/ BPO Wash is being developed for the treatment of acne vulgaris. The regimen combines a topical antibiotic and retinoid gel with a benzoyl peroxide wash. It is intended for patients with acne, including adolescents, as the trial enrolled participants aged 12 years and older.

Who is developing CTGel/ BPO Wash?

GSK plc, which trades under the ticker GSK, is the developer of CTGel/ BPO Wash. The company is advancing this topical acne regimen through clinical development in dermatology.

What phase is CTGel/ BPO Wash in?

CTGel/ BPO Wash has completed a Phase 3 clinical trial. It is an investigational product and is not approved for marketing. The completed Phase 3 study evaluated the tolerability of the combined regimen in acne vulgaris.

What clinical trials is CTGel/ BPO Wash in?

CTGel/ BPO Wash has been studied in one completed Phase 3 trial, NCT00891982, titled a clinical study to evaluate the tolerability of a topical antibiotic and retinoid used in a combined regimen with a BPO wash. The trial enrolled 60 participants with acne vulgaris in the United States.

How was the Phase 3 trial of CTGel/ BPO Wash designed?

The Phase 3 trial NCT00891982 was an active-controlled study that enrolled 60 participants with acne vulgaris. It was randomized but not double-blind, and it included participants aged 12 years and older of all sexes. The study was conducted in the United States and has been completed.