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

Melasma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05911698
• Other study ID #: Fractional laser in melasma
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 28, 2023
• Est. completion date: March 2024

Study information

• Verified date: August 2023
• Source: Assiut University
• Contact: Khadija Qenawi, Doctor
• Phone: +201140109931
• Email: diganova796[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Melanosis
• Melasma

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Khadija Qenawi

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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