Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
30 participants
INTERVENTIONAL
2014-12-30
2025-12-31
Brief Summary
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This study is a pilot study designed to determine feasibility of these procedures.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Ice Pack
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.
Topical EMLA cream
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
65 Years
FEMALE
Yes
Sponsors
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Northwestern University
OTHER
Responsible Party
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Murad Alam
Professor in Dermatology, Otolaryngology-Head and Neck Surgery, and Surgery
Principal Investigators
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Murad Alam, MD
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Locations
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Northwestern University Feinberg School of Medicine, Department of Dermatology
Chicago, Illinois, United States
Countries
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Other Identifiers
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STU106090
Identifier Type: -
Identifier Source: org_study_id
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