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CompletedNCT01545869Updated Apr 7, 2014

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

An interventional study of Fractional carbon dioxide laser in Freckles, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 10 Years and older. Per ClinicalTrials.gov, last updated 2014-04-07.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
10 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Freckles

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Keywords

  • carbon dioxide laser
  • fractional resurfacing
  • freckles
  • melanosis
03

In context

Melanosis

149 studies on the registry are indexed under Melanosis; 38 are open to participants now.

This study's enrollment of 20 is below the median of 40 across 139 interventional studies indexed under Melanosis.

Browse Melanosis studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Fractional carbon dioxide laser

    Procedure: Fractional carbon dioxide laser

Interventions

  • ProcedureFractional 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.

    Also known as: Ablative fractional laser resurfacing

06

What researchers measure

Primary outcomes

  1. treatment success

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

    Time frame: One month

Secondary outcomes

  1. Treatment safety

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

    Time frame: three months

07

Study locations

1 site
  • Dermatology department - faculty of medicine- Cairo University
    Cairo, Egypt
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 7, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01545869
Lead sponsor
Cairo University
Responsible party
Pr. Bakr Mohamed Elzawahry (Professor, Cairo University) — Principal investigator
First posted
Mar 7, 2012
Start date
Mar 2012
Primary completion
Jul 2012
Completion
Oct 2012
Last update
Apr 7, 2014

Study contacts

Bakr M Elzawahry, MD
study chair · Cairo University
Vanessa G Hafez, MD
principal investigator · Cairo University
Aya Fahim, MBBCh
principal investigator · Cairo University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.

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