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

NCT05911698 | Unknown

• 1 other identifier: Fractional laser in melasma
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Melasma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Patients with all types of melasma

OTHER

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

Interventions

Fractional co2 laser DEVICE

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.

Patients with all types of melasma

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Khadija Qenawi: lead

Related Publications (3)

• 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.

  PMID: 21142733 BACKGROUND

• 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.

  PMID: 24858737 BACKGROUND

• 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.

  PMID: 35122202 BACKGROUND

MeSH Terms

Conditions

Melanosis

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Khadija Qenawi, Doctor

  Assiut University

  PRINCIPAL INVESTIGATOR

• Hanan Ahmed, Professor

  Assiut University

  STUDY DIRECTOR

• Reham Maher, Professor

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Khadija Qenawi, Doctor

CONTACT

+201140109931; diganova796@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: March 28, 2023
• First Posted: June 22, 2023
• Study Start: October 28, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: August 15, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share