Ice Versus EMLA for Pain in Laser Hair Removal

March 14, 2024 updated by: Murad Alam, Northwestern University

Comparing the Efficacy of Ice Pack Versus Topical EMLA for Pain Control in Laser Axillary Hair Removal: A Randomized Control Trial

The primary objective of this study is to compare the efficacy of ice pack to topical eutectic mixture of local anesthesia (EMLA) for pain control in diode 810 nm laser axillary hair removal.

This study is a pilot study designed to determine feasibility of these procedures.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University Feinberg School of Medicine, Department of Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria

  1. Subjects are Caucasian or Asian females.
  2. Subjects are 18-65 years old.
  3. Subjects have Fitzpatrick skin type I-III and coarse dark axillary hair.
  4. Subjects are in good health.
  5. Subjects can provide informed consent.
  6. Subjects have the willingness and the ability to understand and communicate with the investigators.

Exclusion Criteria

  1. Subjects who are allergic to lidocaine or prilocaine.
  2. History of methemoglobinemia.
  3. History of recurrent petechial or purpuric lesions.
  4. Bleeding tendency or coagulopathy.
  5. History of laser treatment in axilla.
  6. History of keloid or hypertrophic scarring.
  7. Pregnant or lactating or intends to become pregnant in the next 3 months.
  8. Active skin disease or skin infection in the treatment area.
  9. Subjects with known mental illness or other psychological conditions, such as psychotic disorders, mood disorders, anxiety disorders and cognitive disorders.
  10. History of cold urticaria.
  11. History of current injury or abnormal skin sensation.
  12. Unable to understand the protocol or to give informed consent.
  13. Any other condition that would, in the professional opinion of the investigator, potentially affect response or participation in the clinical clinical study, or would pose as an unacceptable risk to subject.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ice Pack
Other: Ice Pack
Subjects will have 600 grams of ice in clear plastic bag size 18 x 23 cm applied to the randomized axilla for 10 minutes. After 10 minutes, the ice pack will be removed and laser hair treatment will be performed.
Active Comparator: Topical EMLA cream
Drug: Topical EMLA cream
Topical EMLA will be applied approximately 2 mm thick to the randomized axilla with a wooden tongue depressor wrapped with impermeable plastic occlusion dressing for 60 minutes. After 60 minutes, the drug will be removed with regular gauze and saline and laser hair treatment will be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain using the SF-MPQ immediately after treatment
Time Frame: immediately (at 0 min) after laser treatment
immediately (at 0 min) after laser treatment
Pain using the SF-MPQ 5 minutes after treatment
Time Frame: 5 mins after laster treatment
5 mins after laster treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Investigators

  • Principal Investigator: Murad Alam, MD, Northwestern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

December 12, 2014

First Submitted That Met QC Criteria

December 12, 2014

First Posted (Estimated)

December 17, 2014

Study Record Updates

Last Update Posted (Actual)

March 18, 2024

Last Update Submitted That Met QC Criteria

March 14, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU106090

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hair Removal

Clinical Trials on Ice Pack

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sri Lanka

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe