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

Primary Purpose

Freckles

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Fractional carbon dioxide laser
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Freckles focused on measuring carbon dioxide laser, fractional resurfacing, freckles, melanosis

Eligibility Criteria

10 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dermatology department - faculty of medicine- Cairo University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fractional carbon dioxide laser

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Treatment safety
Absence of irreversible changes in color and texture of the facial skin, that can cause patient dissatisfaction

Full Information

First Posted
March 2, 2012
Last Updated
April 4, 2014
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT01545869
Brief Title
Efficacy and Safety of Fractional Carbon Dioxide Laser for Treatment of Facial Freckles.
Official Title
Efficacy and Safety of Fractional Carbon Dioxide Laser for Treatment of Facial Freckles
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Freckles
Keywords
carbon dioxide laser, fractional resurfacing, freckles, melanosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fractional carbon dioxide laser
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Fractional carbon dioxide laser
Other Intervention Name(s)
Ablative fractional laser resurfacing
Intervention Description
SmartXide fractional carbon dioxide laser (DEKA, Florence, Italy). Parameters adjusted for: Power 20 watts, spacing 200 µsec, dwell time 300 µm, stacks 1.
Primary Outcome Measure Information:
Title
treatment success
Description
reduction of freckles number and color density more than 50% in comparison to pre-treatment digital photos
Time Frame
One month
Secondary Outcome Measure Information:
Title
Treatment safety
Description
Absence of irreversible changes in color and texture of the facial skin, that can cause patient dissatisfaction
Time Frame
three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bakr M Elzawahry, MD
Organizational Affiliation
Cairo University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Vanessa G Hafez, MD
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Aya Fahim, MBBCh
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dermatology department - faculty of medicine- Cairo University
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Learn more about this trial

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

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