Topical Cream for Peripheral Neuropathy

Recruiting at 7 trial locations

Overseen By Angela Hansen

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: WinSanTor, Inc

Must be taking: Carboplatin, Paclitaxel

Must not be taking: Pain medications, Vitamin E

Disqualifiers: Peripheral neuropathy, Severe paclitaxel hypersensitivity, Macrovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 19-24 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that you stop taking regular pain medications like gabapentin, pregabalin, amitriptyline, or duloxetine, unless they are opioids for short-term malignant pain. Also, you cannot use local anesthetics or analgesics like lidocaine or capsaicin.

What data supports the effectiveness of the drug Topical Pirenzepine for treating peripheral neuropathy?

Research on mice shows that topical pirenzepine can prevent and reverse symptoms of peripheral neuropathy, such as pain and nerve damage, especially in diabetic conditions. This suggests it might be effective for similar nerve-related issues in humans. ^{1 2 3 4 5}

Is the topical cream for peripheral neuropathy safe for humans?

Topical treatments for peripheral neuropathic pain, like the one being studied, are generally considered safe because they have limited systemic availability, meaning they don't spread much throughout the body, which results in minimal side effects and drug interactions. ^{4 6 7 8 9}

How does the topical cream for peripheral neuropathy differ from other treatments?

The topical cream for peripheral neuropathy is unique because it uses pirenzepine, which is typically not used in standard treatments for neuropathic pain. This cream is applied directly to the skin, potentially reducing systemic side effects associated with oral medications. ^{4 7 10 11 12}

Research Team

Angela Hansen

Principal Investigator

WinSanTor, Inc

Eligibility Criteria

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.

Inclusion Criteria

I am over 18 years old.

Ability to complete patient reported outcome questionnaires by themselves

Ability to sign informed consent and understand the nature of a placebo-controlled trial

Exclusion Criteria

History of sensitive skin

I have nerve damage not caused by previous chemotherapy.

I have problems emptying my bladder or an enlarged prostate.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive once-daily topical WST-057 or placebo for up to 19 weeks, or up to 24 weeks if there is a chemotherapy dose delay, alongside 6 cycles of Carboplatin and Paclitaxel

19-24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Placebo
• Topical Pirenzepine

Trial Overview 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.

Participant Groups

Group I: WST-057 Active Experimental Treatment 1 Intervention

Participants will apply 4 mL QD WST-057 Active topical solution.

Group II: Placebo Experimental Treatment 1 Intervention

Participants will apply 4 mL QD Placebo topical solution

Who Is Running the Clinical Trial?

WinSanTor, Inc

Lead Sponsor

Trials

4

Recruited

190+

Findings from Research

The FDA has only approved one new drug, a topical capsaicin patch, for painful diabetic neuropathy in the last decade, while gabapentinoids and SNRIs remain the preferred treatments due to their better safety and efficacy profiles.

Recent literature highlights the importance of exercise as a complementary therapy, which not only helps manage pain but may also improve the underlying conditions associated with polyneuropathy, such as obesity and diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of Neuropathic Pain in Polyneuropathy. Peltier, AC., Wood, D.[2021]

In a study involving 2177 patients with various chronic pain conditions, two compounded topical creams (Cream I and Cream II) significantly reduced pain intensity scores by 37% and 35%, respectively, compared to a 19% reduction with Voltaren gel.

Both Cream I and Cream II were found to be more effective than Voltaren gel, suggesting that compounded topical formulations may offer better pain relief options for patients with chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective Evaluation on the Analgesic Activities of 2 Compounded Topical Creams and Voltaren Gel in Chronic Noncancer Pain. Somberg, JC., Molnar, J.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Topical Delivery of Muscarinic Receptor Antagonists Prevents and Reverses Peripheral Neuropathy in Female Diabetic Mice. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

A placebo-controlled trial of lamotrigine for painful HIV-associated neuropathy. [2019]

3. Denmark pubmed.ncbi.nlm.nih.gov

Topiramate in painful diabetic polyneuropathy: findings from three double-blind placebo-controlled trials. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Transdermal clonidine versus placebo in painful diabetic neuropathy. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Lamotrigine for HIV-associated painful sensory neuropathies: a placebo-controlled trial. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Management of Neuropathic Pain in Polyneuropathy. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Enriched enrollment randomized double-blind placebo-controlled cross-over trial with phenytoin cream in painful chronic idiopathic axonal polyneuropathy (EPHENE): a study protocol. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Topical Treatment of Peripheral Neuropathic Pain: Applying the Evidence. [2018]

9. Scotland pubmed.ncbi.nlm.nih.gov

0.075% capsaicin lotion for the treatment of painful diabetic neuropathy: A randomized, double-blind, crossover, placebo-controlled trial. [2019]

10. New Zealand pubmed.ncbi.nlm.nih.gov

Ethical justification of single-blind and double-blind placebo-controlled response tests in neuropathic pain and N-of-1 treatment paradigm in clinical settings. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Retrospective Study on the Analgesic Activity of a Topical (TT-CTAC) Cream in Patients With Diabetic Neuropathy and Other Chronic Pain Conditions. [2015]

12. United States pubmed.ncbi.nlm.nih.gov

Retrospective Evaluation on the Analgesic Activities of 2 Compounded Topical Creams and Voltaren Gel in Chronic Noncancer Pain. [2022]