Ice Versus EMLA for Pain in Laser Hair Removal

Hair Removal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02318654
• Other study ID #: STU106090
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 2014
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hair Removal

Intervention

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.

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.

Locations

Country	Name	City	State
United States	Northwestern University Feinberg School of Medicine, Department of Dermatology	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain using the SF-MPQ immediately after treatment		immediately (at 0 min) after laser treatment
Primary	Pain using the SF-MPQ 5 minutes after treatment		5 mins after laster treatment