An interventional study of tranexamic acid and 1064-nm Q-Switched fractional laser in Melasma, sponsored by xjpfW. Completed at 1 site in China. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2021-03-11.
Sponsored by xjpfW · Not applicable, Interventional, and Treatment
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.
149 studies on the registry are indexed under Melanosis; 38 are open to participants now.
This study's enrollment of 30 is below the median of 40 across 139 interventional studies indexed under Melanosis.
Browse Melanosis studies →xjpfW is the lead sponsor of 7 studies on the registry; none are open to participants now.
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.Subjects must be clinically diagnosed by the investigator to melasma and MASI score ≥24.
Exclusion Criteria:
(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
(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
(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
(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
Oral tranexamic acid group(menstrual period\>2days) 250mg bid（exclude menstrual period ）
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
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
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.
Time frame: 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.
Time frame: 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.
Time frame: From 0weeks to 36Weeks
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.
Time frame: 20Weeks，36Weeks
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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