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W0027

Phase 1

Tinea Pedis | Small molecule | Infectious Disease |GSK plc|Last Updated: May 30, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment120

FDA Designations

No designations recorded

Clinical trial landscape

W0027 · 1 trial · 1 indication

Phase 1 1
NCT00509275A Study to Evaluate Efficacy and Safety of Three W0027 Regimens in the Treatment of Moccasin Type Tinea Pedis (MTTP)Tinea Pedis
COMPLETED120 Analytics
PHASE1COMPLETED
A Study to Evaluate Efficacy and Safety of Three W0027 Regimens in the Treatment of Moccasin Type Tinea Pedis (MTTP)
Tinea PedisUnlock trial analytics

Study Endpoints

Primary Endpoints

The primary objective of this study is to assess the subject response to three W0027 regimens in subjects with MTTP.
Week 8

Secondary Endpoints

The secondary objectives of this study are: To assess the safety and tolerability of three W0027 regimens in subjects with MTTP; To assess skin and nail pharmacokinetics of three Albaconazole doses in subjects with MTTP.
Skin and Plasma samples Week 0 (Visit 2) through to Week 8 (Visit 9), Nail samples Week 0 (Visit 2) Week 4(Visit 7) and Week 8(Visit 9)
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALW0027
2EXPERIMENTALW0027
3EXPERIMENTALW0027
4PLACEBO_COMPARATORPlacebo

Interventions

NameTypeDescription
W0027DRUGcapsule
PlaceboDRUGPlacebo
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: * Subjects aged 18-65 years, who have been diagnosed with moccasin type tinea pedis (by positive dermatophyte culture, positive potassium hydroxide/calcofluor white preparation, and a Total Signs and Symptoms Score of at least 4). * Females of childbearing potential must use con...

Countries:United StatesAustralia
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Frequently asked questions about W0027

What is W0027 used for?

W0027 is an investigational small molecule being developed for the treatment of tinea pedis, commonly known as athlete's foot. It is specifically being studied for moccasin type tinea pedis (MTTP), a form of the infection that affects the soles and sides of the feet.

Who makes W0027?

W0027 is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker symbol GSK. The company is conducting clinical research to evaluate the safety and efficacy of this investigational drug for the treatment of tinea pedis.

What phase is W0027 in?

W0027 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and effectiveness. The drug is being studied for the treatment of tinea pedis.

What clinical trials is W0027 in?

W0027 has been studied in one completed clinical trial, identified as NCT00509275. This Phase 1 study evaluated the efficacy and safety of three W0027 regimens in the treatment of moccasin type tinea pedis. The trial enrolled 120 participants in the United States and Australia.

How does W0027 work?

The specific molecular target of W0027 has not been disclosed. As a small molecule, it is designed to interact with biological pathways involved in the treatment of tinea pedis, a fungal infection of the skin. However, the exact mechanism of action has not been publicly detailed.

Is W0027 FDA approved?

W0027 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The drug has completed one clinical trial, but it has not received regulatory approval for the treatment of tinea pedis or any other condition.