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Completed

NCT Number: NCT02427724

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

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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Key information

Age range

25 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Northwestern University Feinberg School of Medicine, Department of Dermatology

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Younger than 25 or older than 65 years of age.
  • Pregnant or lactating.
  • Is a male.
  • 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
  • Has an active infection on the face or upper inner arms (excluding mild acne).
  • Is allergic to lidocaine, tetracaine, or prilocaine.
  • Has kidney disease and/or liver disease.
  • Has G-6-PD and/or pseudocholinesterase deficiency.
  • Is taking a class I anti-arrhythmic medication.
  • Is tanned.
  • Has a history of hyperpigmentation with laser treatment.
  • Has a mental illness.
  • Has a history of a chronic pain condition such as fibromyalgia or vulvodynia.
  • Unable to understand the protocol or to give informed consent.
  • Multiply recurrent episodes of cold sores.
  • Any significant skin disease beyond mild acne.
  • 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.

Treatment and study plan

lidocaine 2.5%/prilocaine 2.5% topical anesthetic

Drug

lidocaine 7%/tetracaine 7% topical anesthetic

Drug

placebo vehicle

Drug

Q-switched 532nm Laser

Device

Primary outcomes

  1. visual analog score (VAS) pain rating

    Time frame: Day of treatment

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

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

The Effect of Topical Anesthetic Using Lidocaine 2.5%/Prilocaine 2.5% Versus Lidocaine 7%/Tetracaine 7% Cream on Patients' Pain and Operative Experience During Treatment With QSwitched 532nm Laser

Important dates

Study start
2015
Primary completion
2024
Study completion
2024
First posted
Apr 28, 2015
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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