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Topical Cream for Peripheral Neuropathy

Phase 2
Waitlist Available
Research Sponsored by WinSanTor, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 19 weeks or 24 weeks for subjects on a chemotherapy dose delay
Awards & highlights

Summary

This trial tests a skin cream called WST-057 on patients receiving chemotherapy with Carboplatin and Paclitaxel. The cream is applied to the skin to help manage side effects from the chemotherapy. Carboplatin and Paclitaxel are frequently used together in treatments for various cancers, including gynecological malignancies.

Who is the study for?
Adults over 18 with advanced solid tumors undergoing chemotherapy (carboplatin and paclitaxel) can join. They must be able to fill out questionnaires, have a life expectancy of at least 6 months, an ECOG status of 0-2, and use effective contraception. Excluded are those with pre-existing neuropathy not from chemo, certain health conditions or treatments that could interfere with the study.
What is being tested?
The trial is testing WST-057, a topical treatment for chemotherapy-induced peripheral neuropathy against a placebo. Participants will apply it daily while receiving six cycles of carboplatin and paclitaxel chemotherapy over up to 24 weeks in this randomized, double-blind study.
What are the potential side effects?
Potential side effects may include skin reactions where WST-057 is applied. Since it's being compared to a placebo which has no active ingredients, any additional side effects would likely be related to individual sensitivities or underlying conditions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~19 weeks or 24 weeks for subjects on a chemotherapy dose delay
This trial's timeline: 3 weeks for screening, Varies for treatment, and 19 weeks or 24 weeks for subjects on a chemotherapy dose delay for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of Treatment-Emergent Adverse Events as assessed by ECG (measuring P Wave, QRS complex, QT interval)
Incidence of Treatment-Emergent Adverse Events as assessed by a dermal assessment (Draize score (scale 0.0-4.0) of the dosing area
Incidence of Treatment-Emergent Adverse Events as assessed by hematology and chemistry blood tests.
+3 more
Secondary study objectives
Activity and Fear of Falling Measurement (Short FES-I)
Chemotherapy dose modifications as assessed by median duration of delays (days) between chemotherapy treatments.
Chemotherapy dose modifications as assessed by percentage of patients requiring dose reductions of chemotherapy.
+15 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: WST-057 ActiveExperimental Treatment1 Intervention
Participants will apply 4 mL QD WST-057 Active topical solution.
Group II: PlaceboExperimental Treatment1 Intervention
Participants will apply 4 mL QD Placebo topical solution
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Peripheral Neuropathy treatments often target pain relief and nerve function improvement. Topical agents like lidocaine work by blocking sodium channels in nerve cells, reducing pain signal transmission. This is crucial for patients as it provides localized pain relief with minimal systemic side effects. Duloxetine, a systemic treatment, inhibits the reuptake of serotonin and norepinephrine, enhancing pain modulation pathways in the central nervous system. This dual action can be particularly beneficial for chemotherapy-induced peripheral neuropathy (CIPN) patients, as it addresses both pain and nerve function. The trial WST-057, involving a topical agent, aims to offer a targeted approach to mitigate CIPN, potentially enhancing patient comfort and treatment adherence by reducing debilitating side effects.

Find a Location

Who is running the clinical trial?

WinSanTor, IncLead Sponsor
3 Previous Clinical Trials
132 Total Patients Enrolled
1 Trials studying Peripheral Neuropathy
58 Patients Enrolled for Peripheral Neuropathy
Angela HansenStudy DirectorWinSanTor, Inc
3 Previous Clinical Trials
132 Total Patients Enrolled
1 Trials studying Peripheral Neuropathy
58 Patients Enrolled for Peripheral Neuropathy
Marian Ijzerman, Ph.DStudy DirectorWinSanTor, Inc

Media Library

Placebo (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05488873 — Phase 2
Peripheral Neuropathy Research Study Groups: Placebo, WST-057 Active
Peripheral Neuropathy Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT05488873 — Phase 2
Placebo (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05488873 — Phase 2
~26 spots leftby Apr 2026