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SB-275833, 1%

Phase 3

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

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
ImpetigoUnlock trial analytics
PHASE3COMPLETED
Topical SB-275833 Ointment, 1% For The Treatment Of Impetigo
Skin Infections, BacterialUnlock trial analytics

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 used for?

SB-275833 is an investigational small molecule being developed by GSK plc for the treatment of impetigo and other bacterial skin infections. It is formulated as a 1% topical ointment and has been studied in Phase 3 clinical trials.

Who makes SB-275833?

SB-275833 is being developed by GSK plc, a global biopharma company listed on the New York Stock Exchange under the ticker GSK. The drug is a small molecule formulated as a 1% topical ointment for bacterial skin infections.

What phase is SB-275833 in?

SB-275833 is in Phase 3 clinical development. Two Phase 3 trials have been completed, one with 210 participants and another with 520 participants, both evaluating the 1% ointment for impetigo and bacterial skin infections. The drug is investigational and not yet approved.

What clinical trials is SB-275833 in?

SB-275833 has been studied in two completed Phase 3 trials: NCT00133848, which enrolled 210 participants with impetigo across India, Italy, Mexico, Netherlands, and Peru, and NCT00133874, which enrolled 520 participants with bacterial skin infections across multiple countries including Canada, France, Germany, and South Africa.

Is SB-275833 the same as a placebo?

No, SB-275833 is an active drug, not a placebo. In clinical trials, it was compared against a topical placebo ointment to evaluate its efficacy in treating impetigo. The trials were randomized and double-blind, meaning neither participants nor investigators knew who received the active drug.