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Clinical Trials/NCT05911698
NCT05911698Not yet recruitingNot Applicable

Fractional co2 Laser Followed by Either Vitamin c or Tranexamic Acid in Treatment of Melasma. Asplit Face Dermoscopic and Clinical Study.

Khadija Qenawi0 sites25 target enrollmentStarted: October 28, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
25
Primary Endpoint
Efficacy and safety of fractional CO2 laser in treatment of melasma.

Study Overview

Brief Summary

The aim of the study:

1.To compare the efficacy and safety of fractional CO2 laser in combination with vitamin c and tranexamic acid in the treatment of melasma.

2 .To assess the value of dermoscope in measuring of the response to treatment in melasma patients compared to clinical scoring.

Detailed Description

Melasma is a chronic dermatologic condition defined by hyperpigmented macules and patches that appear in areas of sun exposure .

Traditionally, the mainstays of treatment for melasma have been topical bleaching agents and strict photoprotection.

Additional adjuvant treatment modalities include chemical peels, dermabrasion, and laser treatments, all of which have demonstrated limited efficacy. There has been an interest in studying the effects of vitamin c and tranexamic acid in melasma.

The development of fractional resurfacing has led to improvements to melasma treatment with decreased incidence of post-inflammatory hyperpigmentation; these improvements are due to the enhanced healing times and decreased inflammation as a result of the formation of microscopic columns of tissue destruction.

These microscopic columns of damaged tissue are surrounded by areas of normal tissue, allowing for shorter migratory paths for the healing keratinocytes.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
20 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • All types of melasma (epidermal, dermal, and mixed) will be included .
  • Patients older than 19 years of age.

Exclusion Criteria

  • Pregnancy, breastfeeding.
  • Patients taking drugs that induce facial pigmentation e.g, oral contraceptive pills, or hormonal replacement therapy at the time of the study or during the past 12 months.
  • Patients using of any topical bleaching within 1 month before recruitment.
  • Employment of chemical peels or laser therapy during the past 6 months.
  • Concomitant use of anticoagulants, bleeding disorders.

Outcomes

Primary Outcomes

Efficacy and safety of fractional CO2 laser in treatment of melasma.

Time Frame: 1year

1.: For each patient, Right side of the face : Fractional ablative CO2 laser will be followed by immediate topical application of vitamin c 3% . Left side of the face: Fractional ablative CO2 laser will be followed by immediate topical application of tranexamic acid. * Fractional ablative CO2 laser sessions will be performed using the following parameters: power 8-10 W (according to the skin type), spacing 1000 μm (5.3% density), dwell time 400 μs, and stack . * During the session, protective goggles will be used both by the patient and by the physician. acid in the treatment of melasma. 2 .To assess the value of dermoscope in measuring of the response to treatment in melasma patients compared to clinical scoring.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Khadija Qenawi
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Khadija Qenawi

Doctor

Assiut University

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