Safety and Efficacy of 1550nm Fractional Laser Treatment for Acne Scars in Fitzpatrick Type IV-VI Skin
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ClinicalTrials.gov Identifier: NCT00641420 |
Recruitment Status :
Completed
First Posted : March 24, 2008
Last Update Posted : March 15, 2022
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Condition or disease | Intervention/treatment | Phase |
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Acne Scarring | Procedure: Fractionated Laser Resurfacing | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 15 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Safety and Efficacy of 1550nm Fractional Laser Treatment for Acne Scars in Fitzpatrick Type IV-VI Skin |
Study Start Date : | September 2007 |
Actual Primary Completion Date : | August 2008 |
Actual Study Completion Date : | September 2008 |

Arm | Intervention/treatment |
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Experimental: Fractional Laser 10mJ
Patients receive fractional laser resurfacing to 17% of the face five times one month apart at 10mJ.
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Procedure: Fractionated Laser Resurfacing
Other Name: Fractionated Laser: FRAXEL |
Experimental: Fractional Laser 40mJ
Patients receive fractional laser resurfacing to 17% of the face five times one month apart at 40mJ.
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Procedure: Fractionated Laser Resurfacing
Other Name: Fractionated Laser: FRAXEL |
- 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%]).
- 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.
- 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

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Ages Eligible for Study: | 18 Years to 59 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00641420
United States, Michigan | |
Henry Ford Health System | |
Detroit, Michigan, United States, 48202 |
Principal Investigator: | David M Ozog, MD | Henry Ford Health System |
Responsible Party: | David M. Ozog, Senior Staff, Henry Ford Health System |
ClinicalTrials.gov Identifier: | NCT00641420 |
Other Study ID Numbers: |
HenryFord4447 |
First Posted: | March 24, 2008 Key Record Dates |
Last Update Posted: | March 15, 2022 |
Last Verified: | March 2022 |
Acne scarring Post inflammatory hyperpigmentation |
Cicatrix Fibrosis Pathologic Processes |