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

NCT ID: NCT02427724

Last Updated: 2025-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Lentigo

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

lidocaine 2.5%/prilocaine 2.5% topical anesthetic

Intervention Type DRUG

Q-switched 532nm Laser

Intervention Type DEVICE

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.

Group Type ACTIVE_COMPARATOR

lidocaine 7%/tetracaine 7% topical anesthetic

Intervention Type DRUG

Q-switched 532nm Laser

Intervention Type DEVICE

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.

Group Type PLACEBO_COMPARATOR

placebo vehicle

Intervention Type DRUG

Q-switched 532nm Laser

Intervention Type DEVICE

Interventions

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lidocaine 2.5%/prilocaine 2.5% topical anesthetic

Intervention Type DRUG

lidocaine 7%/tetracaine 7% topical anesthetic

Intervention Type DRUG

placebo vehicle

Intervention Type DRUG

Q-switched 532nm Laser

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Murad Alam

Professor in Dermatology, Otolaryngology-Head and Neck Surgery, and Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Murad Alam, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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Northwestern University Feinberg School of Medicine, Department of Dermatology

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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STU200401

Identifier Type: -

Identifier Source: org_study_id

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