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

NCT01545869 | Completed DMC

• 1 other identifier: Fractional CO2 in freckles
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Freckles

Keywords

carbon dioxide laser; fractional resurfacing; freckles; melanosis

Outcome Measures

Primary Outcomes (1)

• treatment success

  reduction of freckles number and color density more than 50% in comparison to pre-treatment digital photos

  One month

Secondary Outcomes (1)

• Treatment safety

  three months

Study Arms (1)

Fractional carbon dioxide laser

EXPERIMENTAL

Procedure: Fractional carbon dioxide laser

Interventions

Fractional carbon dioxide laser PROCEDURE

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

Also known as: Ablative fractional laser resurfacing

Fractional carbon dioxide laser

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients affected with facial freckles.
• Age: 10 years or more

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Dermatology department - faculty of medicine- Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Melanosis

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Bakr M Elzawahry, MD

  Cairo University

  STUDY CHAIR

• Vanessa G Hafez, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

• Aya Fahim, MBBCh

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 2, 2012
• First Posted: March 7, 2012
• Study Start: March 1, 2012
• Primary Completion: July 1, 2012
• Study Completion: October 1, 2012
• Last Updated: April 7, 2014

Record last verified: 2014-04

Locations

EG (1)