ClinicalTrials.Veeva

Menu

Ice Versus EMLA for Pain in Laser Hair Removal

Northwestern University logo

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)

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

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems