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

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

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

Sponsors & Collaborators

• Air Force General Hospital of the PLA

  collaborator OTHER_GOV

• First Hospital of China Medical University

  collaborator OTHER

• Chinese Academy of Medical Sciences

  collaborator OTHER

• xjpfW

  lead OTHER

Principal Investigators

• Gang Wang, Prof · Dermatology Derpartment of Xijing Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

FACTORIAL

Eligibility

Min Age

20 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-05-01

Primary Completion

2020-02-01

Completion

2020-05-01

Countries

• China

Study Locations