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Hair RemovalPhase 4NCT02318654

Ice Versus EMLA for Pain in Laser Hair Removal

A Phase 4 study testing Ice Pack and Topical EMLA cream in people with Hair Removal, run by Northwestern University at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for
Hair Removal
What is being tested?
Ice Pack and Topical EMLA cream
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
30 Dec 2014to Dec 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Subjects are Caucasian or Asian females.
  • Subjects are 18-65 years old.
  • Subjects have Fitzpatrick skin type I-III and coarse dark axillary hair.
  • Subjects are in good health.
  • Subjects can provide informed consent.
  • Subjects have the willingness and the ability to understand and communicate with the investigators.

Who cannot join

  • Subjects who are allergic to lidocaine or prilocaine.
  • History of methemoglobinemia.
  • History of recurrent petechial or purpuric lesions.
  • Bleeding tendency or coagulopathy.
  • History of laser treatment in axilla.
  • History of keloid or hypertrophic scarring.
Show all 13Show fewer
  • Pregnant or lactating or intends to become pregnant in the next 3 months.
  • Active skin disease or skin infection in the treatment area.
  • Subjects with known mental illness or other psychological conditions, such as psychotic disorders, mood disorders, anxiety disorders and cognitive disorders.
  • History of cold urticaria.
  • History of current injury or abnormal skin sensation.
  • Unable to understand the protocol or to give informed consent.
  • 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 locations and contacts

1 site in 1 country.

United States1 site
  • Northwestern University Feinberg School of Medicine, Department of Dermatology

    Chicago, Illinois, 60611

Other trials in United States

About this study

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

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.

Conditions
Hair Removal
Being tested
Ice Pack, Topical EMLA cream

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ice PackOther

    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 creamDrug

    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.

Study groups in NCT02318654
Study groupRoleWhat they receive
Ice PackActive comparatorNot described
Receives: Other: Ice Pack
Topical EMLA creamActive comparatorNot described
Receives: Drug: Topical EMLA cream

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain using the SF-MPQ immediately after treatment

    Measured: immediately (at 0 min) after laser treatment

  2. Pain using the SF-MPQ 5 minutes after treatment

    Measured: 5 mins after laster treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2014 (estimated)
  2. Study start30 Dec 2014
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02318654
Sponsor's protocol ID
STU106090
Status last verified
Jun 2026
First submitted
12 Dec 2014
Last updated
1 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ice Pack and Topical EMLA cream in people with Hair Removal, run by Northwestern University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain using the SF-MPQ immediately after treatment (time frame: immediately (at 0 min) after laser treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.

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