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CTGel/ BPO Wash

Phase 3

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

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 used for?

CTGel/ BPO Wash is used for the treatment of acne vulgaris, a common skin condition characterized by pimples, blackheads, and whiteheads. It is a topical combination regimen being developed by GSK plc for dermatology applications. The drug is currently in Phase 3 clinical development.

What does CTGel/ BPO Wash target?

CTGel/ BPO Wash is a small molecule topical treatment for acne vulgaris. While the specific molecular targets are not disclosed, it combines an antibiotic and a retinoid with a benzoyl peroxide (BPO) wash. This regimen is designed to address acne through multiple mechanisms, including antibacterial and skin cell turnover effects.

Who makes CTGel/ BPO Wash?

CTGel/ BPO Wash is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. GSK is conducting clinical trials to evaluate the safety and efficacy of this topical treatment for acne vulgaris.

What phase is CTGel/ BPO Wash in?

CTGel/ BPO Wash is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, and the results will inform potential regulatory submissions for the treatment of acne vulgaris.

What clinical trials is CTGel/ BPO Wash in?

CTGel/ BPO Wash has one completed Phase 3 clinical trial, identified as NCT00891982. This study evaluated the tolerability of a topical antibiotic and retinoid used in a combined regimen with a BPO wash in 60 patients with acne vulgaris. The trial was conducted in the United States and enrolled participants aged 12 years and older.

Is CTGel/ BPO Wash the same as other acne treatments?

CTGel/ BPO Wash is a specific combination regimen developed by GSK plc. It combines a topical antibiotic and retinoid with a benzoyl peroxide wash, which are common ingredients in acne treatments. However, the specific formulation and combination are unique to this investigational drug, and it is not marketed under any other names.