NCT03963466

A Clinical Observation of 1064-nm Q-Switched Fractional Laser Combined With Oral Tranexamic Acid on Treating of Melasma.

A Randomized Controlled Trial of the Efficacy and Safety of 1064-nm Q-Switched Fractional Laser Combined With Oral Tranexamic Acid on Treating of Melasma.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: xjpfW · Academic / Other
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

1.Melasma is a common acquired condition of symmetric hyperpigmentation, typically occurring on the face, with higher prevalence in females and darker skin types. Treatments for melasma include topical, oral, procedural, and combination treatments. 2.1064-nm Q-Switched laser is one of the most widely used lasers for pigmented diseases in recent years. This wavelength laser can be effectively absorbed by pigment, which leads to damage of pigment and melanocyte. Previous 1064-nm Q-Switched laser treatment of melasma requires the use of large flare and low energy scanning repeatedly in the lesion area, and the terminal reaction is reddish and skin lesion temperature increased by 2℃. So the course of treatment is even longer and is closely related to the treatment of the doctor's subjective judgment. Current 1064-nm Q-Switched fractional laser is designed with focusing lens and can be scanned only once for skin lesions during treatment. Further more, the treatment energy of a single point is higher and it has stronger ability to destroy melanin. Finally, 1064-nm Q-Switched fractional laser promotes the expulsion of melanin particles from the superficial dermis and basal epidermis. 3.Tranexamic acid (TA) works by inhibiting the plasmin-plasminogen pathway. Increase in plasmin in keratinocytes leads to increase in production of arachidonic acid and alpha-melanocyte-stimulating hormone (alpha-MSH) production. Thus, by inhibiting the plasmin pathway, TA results in decreased melanogenesis. Studies support the use of oral TA as an adjuvant therapy for in refractory cases of melasma or as a second-line or third-line agent, and there is some early evidence supporting the utility of oral TA as monotherapy. Overall, randomized controlled trials have found that combination treatment regimens using oral TA as adjunct therapy results in greater reduction of melasma.

Conditions

• Melasma

Interventions

Type	Name	Description
DRUG	tranexamic acid	Oral tranexamic acid group(menstrual period\>2days) 250mg bid（exclude menstrual period ）
RADIATION	1064-nm Q-Switched fractional laser	Device: 1064-nm Q-Switched fractional laser is used for melisma with the MASI ≥24 left side of cheek is selected to be treated with 1064-nm Q-Switched fractional laser therapy (8ms, 1.5±0.5J/cm2) once 4 weeks for a total of 5 times
RADIATION	1064-nm Q-Switched laser	Device: 1064-nm Q-Switched laser is used for melisma with the MASI ≥24 right side of cheek is selected to be treated with 1064-nm Q-Switched laser therapy (8ms, 1.5±0.5J/cm2) once 4 weeks for a total of 5 times

Timeline

• Start date: 2019-05-01
• Primary completion: 2020-02-01
• Completion: 2020-05-01
• First posted: 2019-05-24
• Last updated: 2021-03-11

Locations

1 site across 1 country: China