Ice Versus EMLA for Pain in Laser Hair Removal

NCT02318654 | Active Not Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: STU106090
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hair Removal

Outcome Measures

Primary Outcomes (2)

• Pain using the SF-MPQ immediately after treatment

  immediately (at 0 min) after laser treatment

• Pain using the SF-MPQ 5 minutes after treatment

  5 mins after laster treatment

Study Arms (2)

Ice Pack

ACTIVE COMPARATOR

Other: Ice Pack

Topical EMLA cream

ACTIVE COMPARATOR

Drug: Topical EMLA cream

Interventions

Ice Pack OTHER

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.

Ice Pack

Topical EMLA cream DRUG

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.

Topical EMLA cream

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Subjects who are allergic to lidocaine or prilocaine.
• History of methemoglobinemia.
• History of recurrent petechial or purpuric lesions.
• Bleeding tendency or coagulopathy.
• History of laser treatment in axilla.
• History of keloid or hypertrophic scarring.
• Pregnant or lactating or intends to become pregnant in the next 3 months.
• Active skin disease or skin infection in the treatment area.
• Subjects with known mental illness or other psychological conditions, such as psychotic disorders, mood disorders, anxiety disorders and cognitive disorders.
• History of cold urticaria.
• History of current injury or abnormal skin sensation.
• Unable to understand the protocol or to give informed consent.
• 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.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University Feinberg School of Medicine, Department of Dermatology

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Interventions

Lidocaine, Prilocaine Drug Combination

Intervention Hierarchy (Ancestors)

Lidocaine; Acetanilides; Anilides; Amides; Organic Chemicals; Prilocaine; Aniline Compounds; Amines; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Murad Alam, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Dermatology, Otolaryngology-Head and Neck Surgery, and Surgery

Study Record Dates

• First Submitted: December 12, 2014
• First Posted: December 17, 2014
• Study Start: December 30, 2014
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 31, 2025

Record last verified: 2025-01

Locations

US (1)