Ice Versus EMLA for Pain in Laser Hair Removal

Northwestern University

Status: Active, not recruiting

Conditions: Hair Removal

Treatments: Other: Ice Pack; Drug: Topical EMLA cream

Study type: Interventional

Funder types: Other

Identifiers

NCT02318654

STU106090

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Ice Pack

Active Comparator group

Treatment:

Other: Ice Pack

Topical EMLA cream

Active Comparator group

Treatment:

Drug: Topical EMLA cream