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

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.

Study Overview

• Status: Completed
• Conditions: Freckles
• Intervention / Treatment: Procedure: Fractional carbon dioxide laser

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Dermatology department - faculty of medicine- Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Fractional carbon dioxide laser	Procedure: Fractional 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.; Other Names: Ablative fractional laser resurfacing

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Bakr M Elzawahry, MD, Cairo University; Principal Investigator: Aya Fahim, MBBCh, Cairo University

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (ACTUAL): July 1, 2012
• Study Completion (ACTUAL): October 1, 2012

Study Registration Dates

• First Submitted: March 2, 2012
• First Submitted That Met QC Criteria: March 6, 2012
• First Posted (ESTIMATE): March 7, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): April 7, 2014
• Last Update Submitted That Met QC Criteria: April 4, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: melanosis; carbon dioxide laser; fractional resurfacing; freckles
• Additional Relevant MeSH Terms: Skin Diseases; Hyperpigmentation; Pigmentation Disorders; Melanosis
• Other Study ID Numbers: Fractional CO2 in freckles