Clinical trial NCT03963466: A Clinical Observation of 1064-nm Q-Switched Fractional Laser Combined With Oral Tranexamic Acid on Treating of Melasma.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Melasma
Keywords: Melasma
1064-nm Q-Switched Fractional Laser
Tranexamic acid (TA)
Treatment
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
Collaborators: name: Air Force General Hospital of the PLA
name: First Hospital of China Medical University
name: Chinese Academy of Medical Sciences
First posted: 2019-05-24
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Melasma area and severity index (MASI)
timeFrame: From 0weeks to 36Weeks
measure: Antera 3D skin test
timeFrame: From 0weeks to 36Weeks
measure: VISIA image analysis system
timeFrame: From 0weeks to 36Weeks
Secondary outcomes:
measure: Patient self-evaluation
timeFrame: 20Weeks，36Weeks
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Dermatology Derpartment of Xijing Hospital
state: Shaanxi
Study officials:
affiliation: Dermatology Derpartment of Xijing Hospital
name: Gang Wang, Prof
role: PRINCIPAL_INVESTIGATOR
References: