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

Acne Scarring Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00641420
• Other study ID #: HenryFord4447
• Status: Completed
• Phase: N/A
• Start date: September 2007
• Est. completion date: September 2008

Study information

• Verified date: March 2022
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: September 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Acne Scarring
• Cicatrix

Intervention

Procedure:
• Fractionated Laser Resurfacing

Locations

Country	Name	City	State
United States	Henry Ford Health System	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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%]).	6 months
Secondary	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.	6 months
Secondary	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	5 months