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Completed

NCT Number: NCT00641420

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

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.

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Key information

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Henry Ford Health System

Detroit, Michigan, 48202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fractionated Laser Resurfacing

Procedure

Other names: Fractionated Laser: FRAXEL

Primary outcomes

  1. Improvement in acne scarring.

    Time frame: 6 months

    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 outcomes

  1. Dyspigmentation

    Time frame: 6 months

    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.

  2. Pain with treatment

    Time frame: 5 months

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

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Mar 24, 2008
Registry last updated
Mar 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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