Comparison of 1,550 and 755 Laser in a Split-face Trial

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-08

Study Completion Date

2019-10-30

Brief Summary

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Clinical Trial comparing the 1,550-nanometer fractionated photothermolysis system laser to the 755 nanometer picosecond laser using a split-face (Right-Left) comparison. Patients will receive laser treatments at week 0, week 4, and week 8. Photographs will be taken prior to laser treatment at each visit, and at the week 24 follow-up visit. Photographs will be reviewed by blinded assessors to rate each side of the face and change from baseline photos.

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Detailed Description

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This is a Clinical Trial comparing the 1,550-nanometer fractionated photothermolysis system laser to the 755 nanometer picosecond laser using a split-face (Right-Left) comparison. Both of these lasers are currently FDA approved for acne scarring.

Approximately 18 subjects, men and women with Fitzpatrick skin types I through V and facial acne scarring of grades III-IV (moderate to severe) will be enrolled. Both sides of the participants' face should have similar amount and severity of acne scarring. Participants will be over 18 years old. Patients have to be otherwise healthy without a history of skin cancer, keloidal scarring, localized or active infection, immunodeficiency disorders, and light sensitivity.

Patients have to be overall healthy without a history of skin cancer, keloidal scarring, localized or active infection, immunodeficiency disorders, and light sensitivity. Per PI discretion, any serious medical condition that may interfere with the study. In addition, patients who have been taking isotretinoin for a period of 6 months before treatment will be excluded.

Patients will have photographs taken at every visit prior to the laser treatments at week 0, week 4, and week 8. Photographs will also be taken at the week 24 follow-up visit. Photos will then be assessed by qualified blinded reviewers for comparison.

Conditions

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Acne Scars - Mixed Atrophic and Hypertrophic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

All subjects will receive half of their faces treated with each laser. Subjects will be randomized to determine which side of the face is treated with each laser.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Blinded Assessors will be reviewing and scoring the photos after the study is completed.

Study Groups

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1,550 laser

This arm is the side of the face treated with the 1550-nanometer Fracionated Photothermolysis laser.

Group Type ACTIVE_COMPARATOR

1,550 fracionated photothermolysis laser

Intervention Type DEVICE

All subjects will have one side of their face treated with one laser, and the other side with the other laser.

755 laser

This arm is the side of the face treated with the 755-nanometer alexandrite picosecond laser.

Group Type ACTIVE_COMPARATOR

755 picosecond laser

Intervention Type DEVICE

All subjects will have one side of their face treated with one laser, and the other side with the other laser.

Interventions

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1,550 fracionated photothermolysis laser

All subjects will have one side of their face treated with one laser, and the other side with the other laser.

Intervention Type DEVICE

755 picosecond laser

All subjects will have one side of their face treated with one laser, and the other side with the other laser.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Men and women with Fitzpatrick skin types I through V and facial acne scarring of grades III-IV (moderate to severe) will be enrolled. Both sides of the participants' face should have similar amount and severity of acne scarring. Participants will be over 18 years old. Patients have to be otherwise healthy without a history of skin cancer, keloidal scarring, localized or active infection, immunodeficiency disorders, and light sensitivity.

Exclusion Criteria

* Patients have to be overall healthy without a history of skin cancer, keloidal scarring, localized or active infection, immunodeficiency disorders, and light sensitivity. Per PI discretion, any serious medical condition that may interfere with the study. In addition, patients who have been taking isotretinoin for a period of 6 months before treatment will be excluded.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No