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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fractional CO2 laser combined with Tranexamic acid | Active Comparator | one side of the face of all participants will be subjected to low power fractional CO2 laser with a power of 12 watts, spacing 800 micrometer (7.3% density), and dwell time 300 microsecond for 3 sessions every 6 weeks. In addition to Tranexamic acid intradermal microinjections using tranexamic acid 500mg/5ml ampoules, the dose of 1ml syringe with 100mg/ml with maximum of 4ml per session, on the 2nd and the 4th week of each laser session. With total treatment time for each patient of 4 months and another month free of sessions for followup. |
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| Tranexamic acid alone | Active Comparator | the other side of the face of all participants will be subjected Tranexamic acid intradermal microinjections using tranexamic acid 500mg/5ml ampoules, the dose of 1ml syringe with 100mg/ml with maximum of 4ml per session, every 2 weeks for 4 months then another month free of sessions for followup. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fractional CO2 laser | Device | Low power fractional CO2 laser with a power of 12 watts, spacing 800 micrometer (7.3% density), and dwell time 300 microsecond |
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| Measure | Description | Time Frame |
|---|---|---|
| Melanin and Erythema indices change from baseline | 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. | baseline, 18 weeks and 20 weeks |
| Dermoscopic features change from baseline | 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. | baseline, 18 weeks and 20 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eman R Said, MD | Contact | +201110066044 | dremy07@cu.edu.eg | |
| Shereen O Tawfic, MD | Contact | +201220085050 | shereenosamat@yahoo.com |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30431171 | Background | Tawfic SO, Abdel Halim DM, Albarbary A, Abdelhady M. Assessment of combined fractional CO2 and tranexamic acid in melasma treatment. Lasers Surg Med. 2019 Jan;51(1):27-33. doi: 10.1002/lsm.23032. Epub 2018 Nov 15. | |
| 20514787 | Background | Trelles MA, Velez M, Gold MH. The treatment of melasma with topical creams alone, CO2 fractional ablative resurfacing alone, or a combination of the two: a comparative study. J Drugs Dermatol. 2010 Apr;9(4):315-22. |
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| ID | Term |
|---|---|
| D008548 | Melanosis |
| ID | Term |
|---|---|
| D017495 | Hyperpigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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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.
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| Tranexamic acid intradermal microinjections | Drug | Tranexamic acid 500mg/5ml ampules |
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| 24858737 | Background | Jalaly NY, Valizadeh N, Barikbin B, Yousefi M. Low-power fractional CO(2) laser versus low-fluence Q-switch 1,064 nm Nd:YAG laser for treatment of melasma: a randomized, controlled, split-face study. Am J Clin Dermatol. 2014 Aug;15(4):357-63. doi: 10.1007/s40257-014-0080-x. |
| 29027510 | Background | Saki N, Darayesh M, Heiran A. Comparing the efficacy of topical hydroquinone 2% versus intradermal tranexamic acid microinjections in treating melasma: a split-face controlled trial. J Dermatolog Treat. 2018 Jun;29(4):405-410. doi: 10.1080/09546634.2017.1392476. Epub 2017 Nov 9. |