COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01545869
Recruitment Status : Completed
First Posted : March 7, 2012
Last Update Posted : April 7, 2014
Information provided by (Responsible Party):
Pr. Bakr Mohamed Elzawahry, 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.

Condition or disease Intervention/treatment Phase
Freckles Procedure: Fractional carbon dioxide laser Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Fractional Carbon Dioxide Laser for Treatment of Facial Freckles
Study Start Date : March 2012
Actual Primary Completion Date : July 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

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 Name: Ablative fractional laser resurfacing

Primary Outcome Measures :
  1. treatment success [ Time Frame: One month ]
    reduction of freckles number and color density more than 50% in comparison to pre-treatment digital photos

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01545869

Layout table for location information
Dermatology department - faculty of medicine- Cairo University
Cairo, Egypt
Sponsors and Collaborators
Cairo University
Layout table for investigator information
Study Chair: Bakr M Elzawahry, MD Cairo University
Principal Investigator: Vanessa G Hafez, MD Cairo University
Principal Investigator: Aya Fahim, MBBCh Cairo University
Layout table for additonal information
Responsible Party: Pr. Bakr Mohamed Elzawahry, Professor, Cairo University Identifier: NCT01545869    
Other Study ID Numbers: Fractional CO2 in freckles
First Posted: March 7, 2012    Key Record Dates
Last Update Posted: April 7, 2014
Last Verified: April 2014
Keywords provided by Pr. Bakr Mohamed Elzawahry, Cairo University:
carbon dioxide laser
fractional resurfacing
Additional relevant MeSH terms:
Layout table for MeSH terms
Pigmentation Disorders
Skin Diseases