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

Primary Purpose

Lentigo

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
lidocaine 2.5%/prilocaine 2.5% topical anesthetic
lidocaine 7%/tetracaine 7% topical anesthetic
placebo vehicle
Q-switched 532nm Laser
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Lentigo

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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:

  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.

Sites / Locations

  • Northwestern University Feinberg School of Medicine, Department of Dermatology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

lidocaine 2.5%/prilocaine 2.5% topical anesthetic

lidocaine 7%/tetracaine 7% topical anesthetic

placebo vehicle

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 13, 2015
Last Updated
February 17, 2023
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT02427724
Brief Title
The Effect of Topical Anesthetics on Patients' Pain and Operative Experience During Treatment With QSwitched Laser
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 2015 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lentigo

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
lidocaine 2.5%/prilocaine 2.5% topical anesthetic
Arm Type
Active Comparator
Arm Description
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.
Arm Title
lidocaine 7%/tetracaine 7% topical anesthetic
Arm Type
Active Comparator
Arm Description
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.
Arm Title
placebo vehicle
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
lidocaine 2.5%/prilocaine 2.5% topical anesthetic
Intervention Type
Drug
Intervention Name(s)
lidocaine 7%/tetracaine 7% topical anesthetic
Intervention Type
Drug
Intervention Name(s)
placebo vehicle
Intervention Type
Device
Intervention Name(s)
Q-switched 532nm Laser
Primary Outcome Measure Information:
Title
visual analog score (VAS) pain rating
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Murad Alam, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University Feinberg School of Medicine, Department of Dermatology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

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

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