Efficacy and Safety of Fractional Carbon Dioxide Laser for Treatment of Facial Freckles.

Study Overview
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Brief Summary
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Freckles are clusters of melanin in the superficial epidermis. They affect mostly face and sun exposed areas, and appear as flat brown or red macules that fade in winter, usually in a fair complexion patient, but may be present in other skin types. The gold standard in the industry for non-surgical facial rejuvenation, removal of wrinkles, pigmentation, and general sun damage has been the carbon dioxide (CO2) laser since the mid 1990s. The traditional CO2 laser was very effective, however it fell out of favor because it required general anesthesia. It also had a prolonged recovery time. Over the last several years, advances in technology known as fractional resurfacing has made the CO2 laser popular again: Fractional CO2 laser treatment is one of the newest laser rejuvenation technology. It proved successful in treatment of melasma, one of the pigmented dermatoses. To the best of our knowledge, based on a thorough search of literature, no clinical studies assessing fractional CO2 laser in treatment of freckles could be retrieved.

Official Title
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Efficacy and Safety of Fractional Carbon Dioxide Laser for Treatment of Facial Freckles

Conditions
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Freckles

Intervention / Treatment
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* Procedure: Fractional carbon dioxide laser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -Patients affected with facial freckles. Age: 10 years or more Exclusion Criteria: Patients younger than 10 years old. Patients aged 10-21 years who can not provide a written consent of parents or legal guardian. Patients with known tendency to keloid or hypertrophic scar formation. Patients receiving treatment with systemic retinoids or having stopped their course since less than six months duration.

Ages Eligible for Study
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Minimum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fractional carbon dioxide laser<br> | Procedure: Fractional carbon dioxide laser<br>* SmartXide fractional carbon dioxide laser (DEKA, Florence, Italy). Parameters adjusted for: Power 20 watts, spacing 200 µsec, dwell time 300 µm, stacks 1.<br>* Other names: Ablative fractional laser resurfacing;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| treatment success | reduction of freckles number and color density more than 50% in comparison to pre-treatment digital photos | One month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment safety | Absence of irreversible changes in color and texture of the facial skin, that can cause patient dissatisfaction | three months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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carbon dioxide laser, fractional resurfacing, freckles, melanosis