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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01545869

Enrollment

Registered

2012-03-07

Start date

2012-03-31

Completion date

2012-10-31

Last updated

2014-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Freckles

Keywords

carbon dioxide laser, fractional resurfacing, freckles, melanosis

Brief summary

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.

Interventions

PROCEDUREFractional carbon dioxide laser

SmartXide fractional carbon dioxide laser (DEKA, Florence, Italy). Parameters adjusted for: Power 20 watts, spacing 200 µsec, dwell time 300 µm, stacks 1.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

10 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026