Dermatology Derpartment of Xijing Hospital
Xi'an, Shaanxi, 710032, China
NCT Number: NCT03963466
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.
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Notify Me20 year–60 year
All sexes
Interventional
Not applicable
Xi'an, Shaanxi, 710032, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
.Subjects must be clinically diagnosed by the investigator to melasma and MASI score ≥24.
Exclusion criteria
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
Time frame: From 0weeks to 36Weeks
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 measures the changes of skin melanin and hemoglobin before and after treatment quantitatively.
Time frame: From 0weeks to 36Weeks
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: 20Weeks,36Weeks
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.
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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.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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