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

• ClinicalTrials.gov Identifier: NCT05911698
• Recruitment Status: Not yet recruiting
• First Posted: June 22, 2023
• Last Update Posted: August 15, 2023
• Sponsor: Khadija Qenawi
• Information provided by (Responsible Party): Khadija Qenawi, Assiut University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Melasma	Device: Fractional co2 laser	Not Applicable

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 (Clinical Trial)
• Estimated Enrollment: 25 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Fractional co2 Laser Followed by Either Vitamin c or Tranexamic Acid in Treatment of Melasma. Asplit Face Dermoscopic and Clinical Study.
• Estimated Study Start Date: October 28, 2023
• Estimated Primary Completion Date: March 2024
• Estimated Study Completion Date: March 2024

Arms and Interventions

Arm

Intervention/treatment

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.

Outcome Measures

Primary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 20 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Contacts

Contact: Khadija Qenawi, Doctor; +201140109931; diganova796@gmail.com

Sponsors and Collaborators

Khadija Qenawi

Investigators

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

More Information

Publications:

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.

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.

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.

• Responsible Party: Khadija Qenawi, Doctor, Assiut University
• ClinicalTrials.gov Identifier: NCT05911698
• Other Study ID Numbers: Fractional laser in melasma
• First Posted: June 22, 2023
• Last Update Posted: August 15, 2023
• Last Verified: August 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Melanosis; Hyperpigmentation; Pigmentation Disorders; Skin Diseases