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

NCT03963466 | Completed DMC

• 1 other identifier: XijingH-PF-20190430
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Melasma; 1064-nm Q-Switched Fractional Laser; Tranexamic acid (TA); Treatment

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Patient self-evaluation

  20Weeks，36Weeks

Study Arms (4)

group 1

EXPERIMENTAL

(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; Radiation: 1064-nm Q-Switched fractional laser

group 2

EXPERIMENTAL

(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; Radiation: 1064-nm Q-Switched laser

group 3

EXPERIMENTAL

(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

group 4

EXPERIMENTAL

(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

Interventions

tranexamic acid DRUG

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

group 1; group 2

1064-nm Q-Switched fractional laser 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 1; group 3

1064-nm Q-Switched laser 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 2; group 4

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• xjpfW: lead
• Air Force General Hospital of the PLA: collaborator
• First Hospital of China Medical University: collaborator
• Chinese Academy of Medical Sciences: collaborator

Study Sites (1)

Dermatology Derpartment of Xijing Hospital

Xi'an, Shaanxi, 710032, China

Location

MeSH Terms

Conditions

Melanosis

Interventions

Tranexamic Acid; Lasers

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Gang Wang, Prof

  Dermatology Derpartment of Xijing Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Dermatology

Study Record Dates

• First Submitted: May 10, 2019
• First Posted: May 24, 2019
• Study Start: May 1, 2019
• Primary Completion: February 1, 2020
• Study Completion: May 1, 2020
• Last Updated: March 11, 2021

Record last verified: 2021-03

Locations

CN (1)