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.

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.

Study Overview

• Status: Completed
• Conditions: Melasma
• Intervention / Treatment: Drug: tranexamic acid; Radiation: 1064-nm Q-Switched fractional laser; Radiation: 1064-nm Q-Switched laser

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Dermatology Derpartment of Xijing Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	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
Experimental: 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)	Drug: tranexamic acid; Oral tranexamic acid group(menstrual period>2days) 250mg bid（exclude menstrual period ）; 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
Experimental: 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	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
Experimental: 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Melasma area and severity index (MASI)	Quantitative analysis was made according to the area, depth and uniformity of melasma. Pigmentation area was assessed in four areas: the forehead (F) 30%, the right cheek (MR) 30%, the left cheek (ML) 30%, and the mandible (C) 10%. According to the proportion of pigmented spots in the four areas, the scores were: 1 was less than 10%, 2 was 10%-29%, 3 was 30%-49%, 4 was 50%-69%, 5 was 70%-89%, 6 was 90%-100%. Color Depth (D) and Uniformity (H) Scores: 0 - 4 points: 0 points for none, 1 points for slight, 2 points for moderate, 3 points for obvious, 4 points for maximum. MASI = forehead [0.3A (D + H)] + right cheek [0.3A (D + H)] + left cheek [0.3A (D + H)] + mandible [0.1A (D + H)]. The maximum score is 48 and the minimum is 0.	From 0weeks to 36Weeks
Antera 3D skin test	Antera 3D skin test measures the changes of skin melanin and hemoglobin before and after treatment quantitatively.	From 0weeks to 36Weeks
VISIA image analysis system	VISIA image analysis system: different light sources, such as standard, ultraviolet and orthogonal polarization, are used to quantify different skin states. The patients with melasma are judged the number, distribution, area, depth and capillary condition of pigments by surface, ultraviolet and brown spots.	From 0weeks to 36Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient self-evaluation	Through questionnaires, patients' satisfaction with curative effect was investigated, which was divided into very satisfactory (improvement (> 75%), satisfactory (improvement 50% - 75%), general (improvement 25% - 50%) and unsatisfactory (improvement (< 25%). Statistical satisfaction rate was obtained.	20Weeks，36Weeks

Collaborators and Investigators

• Sponsor: xjpfW
• Collaborators: Cancer Institute and Hospital, Chinese Academy of Medical Sciences; First Hospital of China Medical University; Air Force General Hospital of the PLA
• Investigators: Principal Investigator: Gang Wang, Prof, Dermatology Derpartment of Xijing Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Actual): February 1, 2020
• Study Completion (Actual): May 1, 2020

Study Registration Dates

• First Submitted: May 10, 2019
• First Submitted That Met QC Criteria: May 22, 2019
• First Posted (Actual): May 24, 2019

Study Record Updates

• Last Update Posted (Actual): March 11, 2021
• Last Update Submitted That Met QC Criteria: March 10, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Treatment; Melasma; 1064-nm Q-Switched Fractional Laser; Tranexamic acid (TA)
• Additional Relevant MeSH Terms: Skin Diseases; Hyperpigmentation; Pigmentation Disorders; Melanosis; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: XijingH-PF-20190430

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No