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CompletedNCT02427724Updated Jul 1, 2026

The Effect of Topical Anesthetics on Patients' Pain and Operative Experience During Treatment With QSwitched Laser

An Early Phase 1 interventional study of lidocaine 2.5%/prilocaine 2.5% topical anesthetic and lidocaine 7%/tetracaine 7% topical anesthetic in Lentigo, sponsored by Northwestern University. Completed at 1 site in United States. Open to female participants aged 25 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-01.

Sponsored by Northwestern University · Early Phase 1, Interventional, and Other

Phase
Early Phase 1
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
25 Years to 65 Years
Sex
Female
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Study summary

This study will conduct a split-face and -body randomized control trial to compare lidocaine 2.5%/prilocaine 2.5% topical anesthetic (LPTA), lidocaine 7%/tetracaine 7% topical anesthetic (LTTA), and placebo vechicle (PV) on patients' pain perceptions with Q-switched 532nm laser for the treatment of lentigines and/or photorejuvenation.Subjects will fill out a pain score on a visual analog scale (VAS) with 0 being no pain and 10 being most pain after each treatment area is completed.

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Conditions studied

  • Lentigo

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Who can participate

Ages eligible
25 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Patients who have moderate lentigines and/or photodamage and desire laser toning.
  2. Females 25-65 years of age.
  3. In good health.
  4. Have Fitzpatrick phototype I-III.
  5. Willingness and the ability to understand and provide informed consent and communicate with the investigator/study staff.

Exclusion criteria

Exclusion Criteria:

  1. Younger than 25 or older than 65 years of age.
  2. Pregnant or lactating.
  3. Is a male.
  4. Has received the following treatments on the face:

    • ablative or non-ablative laser procedure in the past 3 months
    • radiofrequency device treatment in the past 3 months
    • ultrasound device treatment in the past 3 months
    • medium to deep chemical peel in the past 3 months
  5. Has an active infection on the face or upper inner arms (excluding mild acne).
  6. Is allergic to lidocaine, tetracaine, or prilocaine.
  7. Has kidney disease and/or liver disease.
  8. Has G-6-PD and/or pseudocholinesterase deficiency.
  9. Is taking a class I anti-arrhythmic medication.
  10. Is tanned.
  11. Has a history of hyperpigmentation with laser treatment.
  12. Has a mental illness.
  13. Has a history of a chronic pain condition such as fibromyalgia or vulvodynia.
  14. Unable to understand the protocol or to give informed consent.
  15. Multiply recurrent episodes of cold sores.
  16. Any significant skin disease beyond mild acne.
  17. 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 the subject.
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Study design

Phase
Early Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
48 participants (estimated)

Study arms

  • Active comparator
    lidocaine 2.5%/prilocaine 2.5% topical anesthetic

    Subjects will be screened, assessed, and randomized to be treated with a single pass of the Q-switched 532nm laser after application of LPTA, LTTA, or PV under occlusion to the assigned randomized site.

    Drug: lidocaine 2.5%/prilocaine 2.5% topical anesthetic · Device: Q-switched 532nm Laser

  • Active comparator
    lidocaine 7%/tetracaine 7% topical anesthetic

    Subjects will be screened, assessed, and randomized to be treated with a single pass of the Q-switched 532nm laser after application of LPTA, LTTA, or PV under occlusion to the assigned randomized site.

    Drug: lidocaine 7%/tetracaine 7% topical anesthetic · Device: Q-switched 532nm Laser

  • Placebo comparator
    placebo vehicle

    Subjects will be screened, assessed, and randomized to be treated with a single pass of the Q-switched 532nm laser after application of LPTA, LTTA, or PV under occlusion to the assigned randomized site.

    Drug: placebo vehicle · Device: Q-switched 532nm Laser

Interventions

  • Druglidocaine 2.5%/prilocaine 2.5% topical anesthetic
  • Druglidocaine 7%/tetracaine 7% topical anesthetic
  • Drugplacebo vehicle
  • DeviceQ-switched 532nm Laser
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What researchers measure

Primary outcomes

  1. visual analog score (VAS) pain rating

    Subjects will fill out a visual analog score (VAS) pain rating after treatment with 0 being no pain and 10 being worst pain

    Time frame: Day of treatment

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Study locations

1 site
  • Northwestern University Feinberg School of Medicine, Department of Dermatology
    Chicago, Illinois 60611, United States
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Registry details

Key details

Study ID
NCT02427724
Lead sponsor
Northwestern University
Responsible party
Murad Alam (Professor in Dermatology, Otolaryngology-Head and Neck Surgery, and Surgery, Northwestern University) — Principal investigator
First posted
Apr 28, 2015
Start date
Apr 2015
Primary completion
May 30, 2024
Completion
May 30, 2024
Last update
Jul 1, 2026

Study contacts

Murad Alam, MD
principal investigator · Northwestern University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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