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OpenTrials
Completed

NCT Number: NCT01545869

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

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.

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Key information

Conditions

Freckles Hyperpigmentation Melanosis Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases

Age range

10 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dermatology department - faculty of medicine- Cairo University

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fractional carbon dioxide laser

Procedure

SmartXide fractional carbon dioxide laser (DEKA, Florence, Italy). Parameters adjusted for: Power 20 watts, spacing 200 µsec, dwell time 300 µm, stacks 1.

Other names: Ablative fractional laser resurfacing

Primary outcomes

  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 outcomes

  1. Treatment safety

    Time frame: three months

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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Mar 7, 2012
Registry last updated
Apr 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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