← Back to Search

Cohort 1 (EMLA cream) for Skin Cancer

Phase 2

Recruiting

Led By Carlo M Contreras, MD

Research Sponsored by Ohio State University Comprehensive Cancer Center

Eligibility Criteria Checklist

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

Must have

Histologically confirmed cutaneous melanoma, Merkel cell carcinoma, squamous cell carcinoma, or other cutaneous malignancy for which lymphoscintigraphy and sentinel lymph node biopsy has been recommended.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

Study Summary

This trial is testing how well a cream called EMLA works in reducing pain in patients with skin cancers who are receiving Technetium 99 injections for a procedure called lymphoscintigraphy mapping.

Who is the study for?

This trial is for patients with skin cancers like Squamous Cell Carcinoma and Merkel Cell Carcinoma, who are undergoing a lymphoscintigraphy mapping procedure using Technetium 99 injections. The study aims to include those who need their lead lymph node identified and possibly removed.Check my eligibility

What is being tested?

The trial is testing EMLA topical cream, which contains numbing medicine, against a placebo to see if it reduces pain from the injections during the lymphoscintigraphy procedure in skin cancer patients.See study design

What are the potential side effects?

Potential side effects of EMLA cream may include reactions at the application site such as redness, swelling or itching. Systemic side effects are rare but could involve nervous system or blood-related issues.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have a skin cancer diagnosis that requires a special lymph node biopsy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pain score

Secondary outcome measures

Incidence of adverse events

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Cohort 1 (EMLA cream)Experimental Treatment2 Interventions

Patients apply EMLA cream topically to skin 30 minutes prior to Tc99 lymphoscintigraphy procedure.

Group II: Cohort 2 (placebo cream)Placebo Group2 Interventions

Patients apply placebo cream topically to skin 30 minutes prior to Tc99 lymphoscintigraphy procedure.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ohio State University Comprehensive Cancer CenterLead Sponsor

320 Previous Clinical Trials

289,995 Total Patients Enrolled

Carlo M Contreras, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center

3 Previous Clinical Trials

115 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals above the age of 20 eligible to participate in this study?

"To be eligible for this clinical trial, potential participants must have reached the age of majority (18 years old) and there is no upper age limit specified."

Answered by AI

What is the current number of individuals being admitted into this particular medical trial?

"Indeed, according to the information available on clinicaltrials.gov, this study is actively seeking eligible participants. The trial was originally posted on December 19th, 2023 and most recently updated on January 16th, 2024. Enrolment of approximately 100 individuals will take place at a single designated site."

Answered by AI

Is the enrollment process currently open for this research study?

"According to the information provided on clinicaltrials.gov, this study is currently in the recruitment phase. The initial posting of the trial occurred on December 19th, 2023, and it was last updated on January 16th, 2024."

Answered by AI

Has the Food and Drug Administration granted approval for Cohort 1, which involves the use of EMLA cream?

"Based on our assessment, the safety of Cohort 1 (EMLA cream) is rated as a 2. This rating reflects the fact that there is supporting data indicating its safety in this Phase 2 trial, but no evidence yet to support its efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

EMLA Topical Cream for Treatment of Pain in Patients Receiving Intra-Dermal Technetium 99 Injections for Lymphoscintigraphy for Skin Cancers

Carlo Contreras 2023. "EMLA Topical Cream for Treatment of Pain in Patients Receiving Intra-Dermal Technetium 99 Injections for Lymphoscintigraphy for Skin Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06223659.

All > Merkel Cell Carcinoma