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

This study is not yet open for participant recruitment.
Verified March 2012 by Cairo University
Sponsor:
Information provided by (Responsible Party):
Pr. Bakr Mohamed Elzawahry, Cairo University
ClinicalTrials.gov Identifier:
NCT01545869
First received: March 2, 2012
Last updated: March 6, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention
Freckles
 Procedure: Fractional carbon dioxide laser

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Fractional Carbon Dioxide Laser for Treatment of Facial Freckles

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cairo University:

Primary Outcome Measures:
  • treatment success [ Time Frame: One month ] [ Designated as safety issue: No ]
    reduction of freckles number and color density more than 50% in comparison to pre-treatment digital photos


Secondary Outcome Measures:
  • Treatment safety [ Time Frame: three months ] [ Designated as safety issue: Yes ]
    Absence of irreversible changes in color and texture of the facial skin, that can cause patient dissatisfaction


Estimated Enrollment: 20
Study Start Date: March 2012
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Ablative fractional laser resurfacing

  Eligibility

Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01545869

Contacts
Contact: Vanessa G Hafez, MD 01001688434 ext 002 vanessahafez@hotmail.com

Locations
Egypt
Dermatology department - faculty of medicine- Cairo University Not yet recruiting
Cairo, Egypt
Contact         ho_rash@yahoo.com    
Contact         vanessahafez@hotmail.com    
Principal Investigator: Bakr M Elzawahry, MD            
Principal Investigator: Vanessa G Hafez, MD            
Principal Investigator: Aya Fahim, MBBCh            
Sponsors and Collaborators
Cairo University
Investigators
Study Chair: Bakr M Elzawahry, MD Cairo University
Principal Investigator: Vanessa G Hafez, MD Cairo University
Principal Investigator: Aya Fahim, MBBCh Cairo University
  More Information

No publications provided

Responsible Party: Pr. Bakr Mohamed Elzawahry, Professor, Cairo University
ClinicalTrials.gov Identifier: NCT01545869     History of Changes
Other Study ID Numbers: Fractional CO2 in freckles
Study First Received: March 2, 2012
Last Updated: March 6, 2012
Health Authority: Egypt: Institutional Review Board

Keywords provided by Cairo University:
carbon dioxide laser
fractional resurfacing
freckles
melanosis

Additional relevant MeSH terms:
Melanosis
Hyperpigmentation
Pigmentation Disorders
Skin Diseases

ClinicalTrials.gov processed this record on May 19, 2013