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Safety and Efficacy of 1550nm Fractional Laser Treatment for Acne Scars in Fitzpatrick Type IV-VI Skin

Primary Purpose

Acne Scarring

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Fractionated Laser Resurfacing

About this trial

This is an interventional treatment trial for Acne Scarring focused on measuring Acne scarring, Post inflammatory hyperpigmentation

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Male or female voluntary patients between the ages of 18 and 59 with Fitzpatrick skin type IV-VI as verified by one of the investigators
Patients with clinical diagnosis of ice pick, rolling, or boxcar type ane scarring
Patients able to follow instructions
If patient has a history of cold sores (herpes labialis) they must be willing to take prophylactic valtrex
Written informed consent from the patients (Appendix II)

Exclusion Criteria:

Children (less than 18 years old)
Pregnant or lactating women
Personal history of keloids or hypertrophic scarring
Active acne requiring topical or oral therapy
Accutane or other oral retinoid in past year
Patients with a known allergy to lidocaine
Allergy to valacyclovir in a patient that needs prophylaxis
Patients with an unstable or non controlled underlying medical problem
Patients who are not able to follow instructions
Patients who have participated in a study within the 3 months prior to study entry
Patients who refuse to give written informed consent
Patients with a history of a pigmentary abnormality

Sites / Locations

Henry Ford Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Fractional Laser 10mJ

Fractional Laser 40mJ

Arm Description

Patients receive fractional laser resurfacing to 17% of the face five times one month apart at 10mJ.

Patients receive fractional laser resurfacing to 17% of the face five times one month apart at 40mJ.

Outcomes

Primary Outcome Measures

Improvement in acne scarring.

Blinded evaluators will score improvement of acne via photographs using a quartile grading scale (0 = no improvement, 1 = minor improvement [1-25%], 2 =moderate improvement [26-50%], 3 =marked improvement [51-75%], 4 = very significant improvement [76-100%]).

Secondary Outcome Measures

Dyspigmentation

dyspigmentation will be assessed separately from acne scarring via photographs with blinded evaluators on a scale of 1- 3. 1 (minimal amount of hyperpigmentation), 2 (moderate hyperpigmentation) and 3 (severe amount of hyperpigmentation) depending on the degree of hyperpigmentation compared with their baseline photo.

Pain with treatment

subjects will report any pain with treatment on a 0-10 scale, with zero indicating no pain and 10 indicating the worst pain

Full Information

NCT ID

NCT00641420

First Posted

March 17, 2008

Last Updated

March 10, 2022

Sponsor

Henry Ford Health System

1. Study Identification

Unique Protocol Identification Number

NCT00641420

Brief Title

Safety and Efficacy of 1550nm Fractional Laser Treatment for Acne Scars in Fitzpatrick Type IV-VI Skin

Official Title

Safety and Efficacy of 1550nm Fractional Laser Treatment for Acne Scars in Fitzpatrick Type IV-VI Skin

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

September 2007 (undefined)

Primary Completion Date

August 2008 (Actual)

Study Completion Date

September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Henry Ford Health System

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Fractionated laser resurfacing is commonly used as a treatment for acne scarring in fair skinned individuals. This study aims to test the efficacy and safety in darker skin types. Patients are randomized to either the 10mJ 40mJ dosages and receive a total of five treatments at 17% one month apart. Improvement is judged by a dermatologist as 0-25%, 25-50%, 50-75% or 75-100%. Side effects such as pigmentary abnormalities and pain are also evaluated.

Detailed Description

Background: Ablative resurfacing lasers are effective for treatment of acne scars, but they have a high risk of complications. Fractional lasers have less severe side effects but more moderate efficacy than ablative devices. Studies were performed in individuals with Fitzpatrick skin type I to VI. Objective: To determine the efficacy and safety of an erbium 1,550-nm fractional laser in the treatment of facial acne scars in Fitzpatrick skin types IV to VI. Methods: We conducted a prospective, single-blind, randomized trial in patients with acne scars (n=15), skin type IV to VI, with a 1,550-nm erbium fractionated laser. Patients were divided into two groups; one was treated with 10 mJ and the other with 40 mJ. Five monthly laser sessions were performed. A patient questionnaire was distributed.

6. Conditions and Keywords

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

Acne Scarring

Keywords

Acne scarring, Post inflammatory hyperpigmentation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fractional Laser 10mJ

Arm Type

Experimental

Arm Description

Patients receive fractional laser resurfacing to 17% of the face five times one month apart at 10mJ.

Arm Title

Fractional Laser 40mJ

Arm Type

Experimental

Arm Description

Patients receive fractional laser resurfacing to 17% of the face five times one month apart at 40mJ.

Intervention Type

Procedure

Intervention Name(s)

Fractionated Laser Resurfacing

Other Intervention Name(s)

Fractionated Laser: FRAXEL

Primary Outcome Measure Information:

Title

Improvement in acne scarring.

Description

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Dyspigmentation

Description

Time Frame

6 months

Title

Pain with treatment

Description

subjects will report any pain with treatment on a 0-10 scale, with zero indicating no pain and 10 indicating the worst pain

Time Frame

5 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

59 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female voluntary patients between the ages of 18 and 59 with Fitzpatrick skin type IV-VI as verified by one of the investigators Patients with clinical diagnosis of ice pick, rolling, or boxcar type ane scarring Patients able to follow instructions If patient has a history of cold sores (herpes labialis) they must be willing to take prophylactic valtrex Written informed consent from the patients (Appendix II) Exclusion Criteria: Children (less than 18 years old) Pregnant or lactating women Personal history of keloids or hypertrophic scarring Active acne requiring topical or oral therapy Accutane or other oral retinoid in past year Patients with a known allergy to lidocaine Allergy to valacyclovir in a patient that needs prophylaxis Patients with an unstable or non controlled underlying medical problem Patients who are not able to follow instructions Patients who have participated in a study within the 3 months prior to study entry Patients who refuse to give written informed consent Patients with a history of a pigmentary abnormality

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David M Ozog, MD

Organizational Affiliation

Henry Ford Health System

Official's Role

Principal Investigator

Facility Information:

Facility Name

Henry Ford Health System

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy of 1550nm Fractional Laser Treatment for Acne Scars in Fitzpatrick Type IV-VI Skin

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