What side effects are associated with this type of intervention?

Common topical treatments for pain include capsaicin cream, lidocaine gel, and phenytoin cream. Capsaicin cream can cause skin irritation and a burning sensation at the application site. Lidocaine gel may lead to localized reactions such as redness, swelling, and irritation. Phenytoin cream has been reported to be effective in reducing pain without significant side effects, although more extensive studies are needed to confirm its safety profile.

What prior FDA approvals exist?

The FDA has approved several topical analgesics for the treatment of pain, including lidocaine patches, diclofenac gel, and capsaicin cream. These treatments are used for various types of pain, such as neuropathic pain, osteoarthritis, and musculoskeletal pain. While Menadione Topical Lotion is being studied for its protective and soothing effects on skin discomfort in cancer patients, similar FDA-approved treatments focus on alleviating pain and inflammation through topical application, providing localized relief with minimal systemic side effects.

What other types of research exist?

Promising alternatives to Menadione Topical Lotion for treating skin discomfort and psychological distress in pain patients include topical bimatoprost for chemotherapy-induced eyelash alopecia and low-dose oral or topical minoxidil for alopecia related to systemic cancer therapy. These treatments have shown potential in clinical settings and may offer similar protective and soothing effects on the skin.

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Menadione Lotion for Cancer-Related Skin Discomfort

N/A

Waitlist Available

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 years or older

Ability to reliably apply Menadione Topical Lotion / placebo twice a day to the face

Must not have

Cutaneous metastases, skin cancer, or history of precancerous skin lesions involving the face and/or chest

Use of topical corticosteroids on the face and/or chest at the time of study entry or anticipated use in the next 8 weeks

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 8 weeks

Awards & highlights

All Individual Drugs Already Approved

Summary

This trial studies a menadione lotion to help cancer patients with skin discomfort and distress from their treatments. The lotion is applied to the skin to soothe and protect it, aiming to reduce rashes and pain. Menadione, also known as vitamin K3, has been studied for its potential to activate certain skin receptors and reduce skin rashes caused by cancer treatments.

Who is the study for?

Adults starting or within 3 days of beginning treatment with panitumumab, erlotinib hydrochloride, or cetuximab for cancer. Participants must be able to apply lotion twice daily and complete questionnaires. Excluded are those using certain skin treatments, pregnant or nursing women, and individuals not practicing contraception.

What is being tested?

The trial is testing menadione topical lotion versus a placebo to see if it can prevent skin discomfort and reduce psychological distress in patients treated with specific cancer drugs. It includes applying the lotion regularly and answering questionnaires about their condition.

What are the potential side effects?

While the side effects of menadione topical lotion aren't detailed here, typical concerns may include local skin reactions like redness or irritation at the site of application.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I can apply a lotion to my face twice daily without help.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have skin cancer or precancerous skin lesions on my face/chest.

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I am using or plan to use topical corticosteroids on my face or chest.

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I am currently breastfeeding.

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I currently have a rash on my face or chest.

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I am not willing to use birth control during the study due to its potential risks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Face

Secondary study objectives

Long-term Cutaneous Discomfort as Measured by the Change From Baseline in Face Pain Scale at 4 Weeks (Treatment-regimen Estimand)

Long-term Psychosocial Discomfort as Measured by the Change From Baseline in Psychological Distress Score at 4 Weeks (Treatment-regimen Estimand)

The Number of Patients Experiencing Worst Toxicity

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm I (lotion)Experimental Treatment3 Interventions

Patients apply menadione topical lotion BID for 28 days.

Group II: Arm II (placebo)Placebo Group2 Interventions

Patients apply topical placebo lotion BID for 28 days.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

management of therapy complications

2008

Completed Phase 3

~3940

0 / 7Eligibility criteria met

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

Common treatments for pain include topical agents, systemic medications, and integrative therapies. Topical agents like corticosteroids and capsaicin work by reducing inflammation and desensitizing pain receptors in the skin. Systemic medications, such as NSAIDs and opioids, act on the central nervous system to block pain signals. Integrative therapies, including acupuncture and manual therapy, may modulate pain through descending pathways and the release of endogenous opioids. Understanding these mechanisms helps pain patients and their doctors choose the most effective treatment, minimize side effects, and improve overall quality of life.

The Role of Descending Modulation in Manual Therapy and Its Analgesic Implications: A Narrative Review.