Fractional co2 Laser Followed by Either Vitamin c or Tranexamic Acid in Treatment of Melasma.

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Melasma
• Intervention / Treatment: Device: Fractional co2 laser

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 Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Khadija Qenawi, Doctor; Phone Number: +201140109931; Email: diganova796@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Pregnancy, breastfeeding.
2. 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.
3. Patients using of any topical bleaching within 1 month before recruitment.
4. Employment of chemical peels or laser therapy during the past 6 months.
5. Concomitant use of anticoagulants, bleeding disorders.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Patients with all types of melasma; Fractional ablative CO2 laser : 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.

Device: Fractional co2 laser; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy and safety of fractional CO2 laser in treatment of melasma.	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.	1year

Collaborators and Investigators

• Sponsor: Khadija Qenawi
• Investigators: Principal Investigator: Khadija Qenawi, Doctor, Assiut University; Study Director: Hanan Ahmed, Professor, Assiut University; Study Director: Reham Maher, Professor, Assiut University

Publications and helpful links

General Publications

• Jalaly NY, Valizadeh N, Barikbin B, Yousefi M. Low-power fractional CO(2) laser versus low-fluence Q-switch 1,064 nm Nd:YAG laser for treatment of melasma: a randomized, controlled, split-face study. Am J Clin Dermatol. 2014 Aug;15(4):357-63. doi: 10.1007/s40257-014-0080-x.
• Neeley MR, Pearce FB, Collawn SS. Successful treatment of malar dermal melasma with a fractional ablative CO(2) laser in a patient with type V skin. J Cosmet Laser Ther. 2010 Dec;12(6):258-60. doi: 10.3109/14764172.2010.538412.
• Lai D, Zhou S, Cheng S, Liu H, Cui Y. Laser therapy in the treatment of melasma: a systematic review and meta-analysis. Lasers Med Sci. 2022 Jun;37(4):2099-2110. doi: 10.1007/s10103-022-03514-2. Epub 2022 Feb 5.

Study record dates

Study Major Dates

• Study Start (Estimated): October 28, 2023
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: March 28, 2023
• First Submitted That Met QC Criteria: June 11, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): August 15, 2023
• Last Update Submitted That Met QC Criteria: August 14, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Hyperpigmentation; Pigmentation Disorders; Melanosis
• Other Study ID Numbers: Fractional laser in melasma

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No