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SB-275833, 1%

Phase 3

Impetigo | Small molecule | Infectious Disease |GSK plc|Last Updated: Jan 23, 2017

Target and mechanism

ModalitySmall molecule

Also known as SB-275833 ointment, 1%

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment210

FDA Designations

No designations recorded

Clinical trial landscape

SB-275833, 1% · 2 trials · 2 indications

Phase 3 2
NCT00133848Treatment Of Impetigo With Topical SB-275833 Ointment, 1% Versus Topical Placebo OintmentImpetigo
COMPLETED210 Analytics
NCT00133874Topical SB-275833 Ointment, 1% For The Treatment Of ImpetigoSkin Infections, Bacterial
COMPLETED520 Analytics
PHASE3COMPLETED
Treatment Of Impetigo With Topical SB-275833 Ointment, 1% Versus Topical Placebo Ointment
Impetigo
NCT00133848210
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PHASE3COMPLETED
Topical SB-275833 Ointment, 1% For The Treatment Of Impetigo
Skin Infections, Bacterial
NCT00133874520
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Study Endpoints

Primary Endpoints

Clinical response of impetigo at end of therapy visit. Clinical response of success is defined as no further need for antibacterial treatment.
Clinical response assessed at end of therapy visit. Clinical success defined by the need for no additional antibiotic treatment.
7 Days

Secondary Endpoints

Clinical response of impetigo at follow up visit. Impetigo lesion area at end of therapy and follow up visits.
Clinical response assessed at follow up visit. Microbiologic response at end of therapy and follow up visits. Impetigo lesion area measured at end of therapy and follow up visits.
7 Days
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
PurposeTREATMENT

Interventions

NameTypeDescription
SB-275833 ointment, 1%DRUG -
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Eligibility Criteria

Age Range9 Months to N/A
SexALL
Healthy VolunteersNo
Study Sites22

Inclusion criteria: * Must have primary impetigo with total lesion area being 100 square centimeters or less. * Women who could bear children must have a negative urine pregnancy test and agree to either abstain from sexual intercourse or the use of specific effective contraceptive measures. Exclu...

Countries:IndiaItalyMexicoNetherlandsPeruCanadaCosta RicaFranceGermanyPolandSouth Africa
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Frequently asked questions about SB-275833, 1%

What is SB-275833, 1%?

SB-275833, 1% is a topical small molecule ointment being developed by GSK plc for the treatment of impetigo and other bacterial skin infections. It is applied directly to the skin and is in Phase 3 clinical development. It is also known as SB-275833 ointment, 1%.

What is SB-275833, 1% used for?

SB-275833, 1% is being developed for the treatment of impetigo and bacterial skin infections. It is a topical ointment applied to affected skin. The clinical program has studied it in patients with impetigo, including a Phase 3 trial comparing it to topical placebo ointment.

Who makes SB-275833, 1%?

SB-275833, 1% is developed by GSK plc, which trades on the New York Stock Exchange under the ticker GSK. GSK is the sponsor of the clinical trials evaluating this topical ointment for impetigo and bacterial skin infections.

What phase is SB-275833, 1% in?

SB-275833, 1% is in Phase 3 clinical development. It is an investigational topical ointment and has not been approved by the FDA. The Phase 3 program includes completed trials in impetigo and bacterial skin infections.

What clinical trials is SB-275833, 1% in?

SB-275833, 1% has been studied in two completed Phase 3 trials: NCT00133874, which enrolled 520 patients with bacterial skin infections across multiple countries, and NCT00133848, which enrolled 210 patients with impetigo and compared the ointment to topical placebo. Both trials are completed.

Is SB-275833, 1% the same as SB-275833 ointment, 1%?

Yes, SB-275833, 1% and SB-275833 ointment, 1% refer to the same investigational product. The full name includes the concentration and dosage form, but both names describe the same topical small molecule ointment developed by GSK plc for impetigo and bacterial skin infections.