Melasma
Conditions
Keywords
Melasma, Tranexamic acid, Fractional CO2 laser
Brief summary
The objective of this study is to assess and compare the efficacy of tranexamic acid intradermal microinjection alone versus its combination with low power fractional CO2 laser in a sequential pattern. In all participants one half of the face will be randomly assigned to low power fractional CO2 laser while other side to Tranexamic acid intradermal microinjections on the 1st session. This split face session will be repeated every six weeks for 3 sessions. In addition, Tranexamic acid intradermal microinjections will be applied for full face at the 2nd and 4th week of each split face session. The response will be evaluated by the Melanin and erythema Indices which will be measured using reflectance spectrophotometer, Dermoscopy and photography before starting the study, two and four weeks after the last session. The sessions will take 4 months for each patient and another one month free of sessions for follow up.
Interventions
DEVICEFractional CO2 laser
Low power fractional CO2 laser with a power of 12 watts, spacing 800 micrometer (7.3% density), and dwell time 300 microsecond
DRUGTranexamic acid intradermal microinjections
Tranexamic acid 500mg/5ml ampules
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Each participate will be assigned to both arms (split face manner). One half of the face will be assigned to Tranexamic acid alone and the other side of the face will be assigned to combined Tranexamic acid and Fractional CO2 laser. Both sides of the face will take the same time of treatment and will be assessed at the same time.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Patients with bilateral symmetrical facial melasma
Exclusion criteria
* Pregnancy and lactation. * Patients taking oral contraceptive pills or hormonal replacement therapy at the time of the study or during the past 12 months. * Concomitant use of anticoagulants. * Bleeding disorders. * Personal or family history of deep venous thrombosis or thromboembolic events. * Scarring and keloid tendency. * Active skin infection, active Herpes simplex virus. * History of Post-inflammatory hyperpigmentation. * History of photosensitivity or photosensitizing medication as sulfonamides tetracycline,retinoids, bleaching creams, peeling and laser two months before the study. * Occupational sun exposure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Melanin and Erythema indices change from baseline | baseline, 18 weeks and 20 weeks | Comparing the effect of Tranexamic acid intradermal microinjection alone versus its combination with low power fractional CO2 laser in a sequential pattern on melasma improvement by measuring the Melanin and erythema Indices (MI and EI) using reflectance spectrophotometer before starting the study, two and four weeks after the last session. |
| Dermoscopic features change from baseline | baseline, 18 weeks and 20 weeks | Comparing the effect of Tranexamic acid intradermal microinjection alone versus its combination with low power fractional CO2 laser in a sequential pattern on melasma improvement by Dermoscopy before starting the study, two and four weeks after the last session. |
Contacts
Primary ContactEman R Said, MD
Backup ContactShereen O Tawfic, MD
Outcome results
None listed