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

Not Applicable

Completed

• Conditions: Freckles
• Interventions: Procedure: Fractional carbon dioxide laser

• Registration Number: NCT01545869
• Lead Sponsor: Cairo University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-02
• Study First Submitted QC: 2012-03-06
• Study First Posted: 2012-03-07
• Primary Completion: 2012-07
• Study Completion: 2012-10
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-04
• Last Update Posted: 2014-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fractional carbon dioxide laser	Fractional carbon dioxide laser	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Dermatology department - faculty of medicine- Cairo University; 🇪🇬 Cairo, Egypt