Recruiting
Phase 2

EMLA

Sponsor:

Ohio State University Comprehensive Cancer Center

Code:

NCT06223659

Conditions

Cutaneous Melanoma

Merkel Cell Carcinoma

Skin Squamous Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Eutectic Mixture of Local Anesthetics

Placebo Administration

Questionnaire Administration

Study Details

Brief summary:

This phase II trial tests how well EMLA topical cream works in treating pain in patients with skin cancers receiving Technetium 99 injections for a lymphoscintigraphy mapping procedure. A lymphoscintigraphy mapping procedure is used to find the main or lead lymph node (tissue that fight infection) so it can be removed and checked for tumor cells. Using lymphoscintigraphy to highlight and then surgically remove lymph nodes is standard way to treat skin cancer for many patients. The Technetium 99 injections used for lymphoscintigraphy can be briefly painful due to the sensitivity of the nerve endings in the skin. The EMLA topical cream, which contains a numbing medicine to block pain from nerve endings, has been studied in breast cancer patients with a difference in pain reported, but this is the first time it has been studied in patients undergoing lymphoscintigraphy for skin cancer. This study may help researchers learn whether the use of EMLA cream may improve the associated pain at the time of the lymphoscintigraphy procedure.

Conditions

Cutaneous Melanoma

Merkel Cell Carcinoma

Skin Squamous Cell Carcinoma

Study ID

NCT06223659

Start date

Dec 19, 2023

Status verified date

Mar, 2026

Completion date

Oct 31, 2026

Anticipated

Primary completion date

Oct 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Biologic males or females
  • 18 - 99 years of age
  • 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.

Exclusion Criteria:

  • Known allergy or intolerance to EMLA cream, lidocaine, prilocaine, or any other local anesthetic
  • History of adhesive allergy
  • Contraindication to Tc99 injection for sentinel lymph node mapping
  • Incarcerated patients
  • Patients incapable of independently providing consent
  • Mucosal or genital lymphoscintigraphy site
  • Pregnancy
  • Participant self-declared or Ohio State University (OSU) medical chart listing chronic pain as a pre-existing diagnosis
  • Participants with chronic pain as defined by the Centers for Disease Control and Prevention (CDC):"pain lasting 3 months or more that can be caused by a disease or condition, injury, medical treatment, or unknown reason" excluding those with stable co-morbid conditions such as peripheral neuropathy, fibromyalgia, arthritis, and cancer-related pain who do not require narcotics. Patients who require narcotics at any time within the 7-day period leading up to the procedure

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Cohort 2 (placebo cream)

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

experimental: Cohort 1 (EMLA cream)

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

Interventions

Eutectic Mixture of Local Anesthetics

Apply topically to skin

Placebo Administration

Apply topically to skin

Questionnaire Administration

Ancillary studies

Primary outcome measure

  • Pain score [ Time Frame: Up to 1 year ]

Central Contacts and Locations

Central contacts

The Ohio State University Comprehensive Cancer Center

800-293-5066OSUCCCClinicaltrials@osumc.edu

Locations

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Carlo M. Contreras, MD

614-366-3681Carlo.Contreras@osumc.edu

Principal Investigator:

Carlo M. Contreras, MD

More Information

Sponsor

Ohio State University Comprehensive Cancer Center

Last update posted

Mar 10, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center on 2026-03-10.