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Trial record 12 of 1686 for:    CARBON DIOXIDE AND dioxide

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.
 
ClinicalTrials.gov Identifier: NCT01545869
Recruitment Status : Completed
First Posted : March 7, 2012
Last Update Posted : April 7, 2014
Sponsor:
Information provided by (Responsible Party):
Pr. Bakr Mohamed Elzawahry, Cairo University

Tracking Information
First Submitted Date  ICMJE March 2, 2012
First Posted Date  ICMJE March 7, 2012
Last Update Posted Date April 7, 2014
Study Start Date  ICMJE March 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2012)
treatment success [ Time Frame: One month ]
reduction of freckles number and color density more than 50% in comparison to pre-treatment digital photos
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01545869 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 6, 2012)
Treatment safety [ Time Frame: three months ]
Absence of irreversible changes in color and texture of the facial skin, that can cause patient dissatisfaction
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Fractional Carbon Dioxide Laser for Treatment of Facial Freckles.
Official Title  ICMJE Efficacy and Safety of Fractional Carbon Dioxide Laser for Treatment of Facial Freckles
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Freckles
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Fractional carbon dioxide laser
Intervention: Procedure: Fractional carbon dioxide laser
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 6, 2012)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01545869
Other Study ID Numbers  ICMJE Fractional CO2 in freckles
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pr. Bakr Mohamed Elzawahry, Cairo University
Study Sponsor  ICMJE Cairo University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Bakr M Elzawahry, MD Cairo University
Principal Investigator: Vanessa G Hafez, MD Cairo University
Principal Investigator: Aya Fahim, MBBCh Cairo University
PRS Account Cairo University
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP