This trial is active, not recruiting.

Condition hair removal
Treatments ice pack, topical emla cream
Sponsor Northwestern University
Start date December 2014
End date December 2016
Trial size 30 participants
Trial identifier NCT02318654, STU106090


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
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
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.

Primary Outcomes

Pain using the SF-MPQ immediately after treatment
time frame: immediately (at 0 min) after laser treatment
Pain using the SF-MPQ 5 minutes after treatment
time frame: 5 mins after laster treatment

Eligibility Criteria

Female participants from 18 years up to 65 years old.

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.

Additional Information

Official title Comparing the Efficacy of Ice Pack Versus Topical EMLA for Pain Control in Laser Axillary Hair Removal: A Randomized Control Trial
Principal investigator Murad Alam, MD
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Northwestern University.