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

NCT02427724 | Active Not Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: STU200401
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lentigo

Outcome Measures

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

  Day of treatment

Study Arms (3)

lidocaine 2.5%/prilocaine 2.5% topical anesthetic

ACTIVE COMPARATOR

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

lidocaine 7%/tetracaine 7% topical anesthetic

ACTIVE COMPARATOR

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 vehicle

PLACEBO COMPARATOR

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

lidocaine 2.5%/prilocaine 2.5% topical anesthetic DRUG

lidocaine 2.5%/prilocaine 2.5% topical anesthetic

lidocaine 7%/tetracaine 7% topical anesthetic DRUG

lidocaine 7%/tetracaine 7% topical anesthetic

placebo vehicle DRUG

placebo vehicle

Q-switched 532nm Laser DEVICE

lidocaine 2.5%/prilocaine 2.5% topical anesthetic; lidocaine 7%/tetracaine 7% topical anesthetic; placebo vehicle

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University Feinberg School of Medicine, Department of Dermatology

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Lentigo

Interventions

Lidocaine; Prilocaine; Anesthetics, Local; Tetracaine; Lasers

Condition Hierarchy (Ancestors)

Melanosis; Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Murad Alam, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Dermatology, Otolaryngology-Head and Neck Surgery, and Surgery

Study Record Dates

• First Submitted: April 13, 2015
• First Posted: April 28, 2015
• Study Start: April 1, 2015
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 31, 2025

Record last verified: 2025-01

Locations

US (1)