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

NCT ID: NCT03963466

Last Updated: 2021-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-01
• Study Completion Date: 2020-05-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

group 1

(left side of cheek) 1064-nm Q-Switched fractional laser+drug Device: 1064-nm Q-Switched fractional laser is used for melisma with the MASI ≥24 Drug: Oral tranexamic acid group(menstrual period\>2days)

Group Type: EXPERIMENTAL

tranexamic acid

Intervention Type: DRUG

Oral tranexamic acid group(menstrual period\>2days) 250mg bid（exclude menstrual period ）

1064-nm Q-Switched fractional laser

Intervention Type: RADIATION

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

group 2

(right side of cheek) 1064-nm Q-Switched laser+drug Device: 1064-nm Q-Switched laser is used for melisma with the MASI ≥24 Drug: Oral tranexamic acid group(menstrual period\>2days)

Group Type: EXPERIMENTAL

tranexamic acid

Intervention Type: DRUG

Oral tranexamic acid group(menstrual period\>2days) 250mg bid（exclude menstrual period ）

1064-nm Q-Switched laser

Intervention Type: RADIATION

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

group 3

(left side of cheek) 1064-nm Q-Switched fractional laser Device: 1064-nm Q-Switched fractional laser is used for melisma with the MASI ≥24

Group Type: EXPERIMENTAL

1064-nm Q-Switched fractional laser

Intervention Type: RADIATION

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

group 4

(right side of cheek) 1064-nm Q-Switched laser Device: 1064-nm Q-Switched laser is used for melisma with the MASI ≥24

Group Type: EXPERIMENTAL

1064-nm Q-Switched laser

Intervention Type: RADIATION

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

Interventions

tranexamic acid

Oral tranexamic acid group(menstrual period\>2days) 250mg bid（exclude menstrual period ）

Intervention Type: DRUG

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

Intervention Type: 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

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

.Subjects must be clinically diagnosed by the investigator to melasma and MASI score ≥24.

• no other treatment was performed for the skin lesions for half a year before the treatment
• (patients with a "no" in any of the above criteria are not eligible for inclusion) .Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted.

Exclusion Criteria

• subjects with a recent history of exposure to sunlight;
• subjects allergic to topical anesthesia;
• subjects with scar constitution;
• subjects with skin malignant tumors or precancerous lesions; .subjects with diabetes, heart disease, epilepsy, connective tissue disease, etc.
• subjects who Pregnant or breast feeding;
• subjects with recent skin infections (such as viruses, bacteria, etc.);
• the methods are being used to treat subjects with similar diseases;
• subject who have taken isotretinoin A in the past year; .subject with facial dermatitis.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Air Force General Hospital of the PLA

OTHER_GOV

Sponsor Role: collaborator

First Hospital of China Medical University

OTHER

Sponsor Role: collaborator

Chinese Academy of Medical Sciences

OTHER

Sponsor Role: collaborator

xjpfW

OTHER

Sponsor Role: lead

Responsible Party

xjpfW

Head of Dermatology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Gang Wang, Prof

Role: PRINCIPAL_INVESTIGATOR

Dermatology Derpartment of Xijing Hospital

Locations

Dermatology Derpartment of Xijing Hospital

Xi'an, Shaanxi, China

Countries

China

Other Identifiers

XijingH-PF-20190430

Identifier Type: -

Identifier Source: org_study_id