Clinical trial NCT03899233: Tranexamic Acid vs. Combination With Fractional Carbon Dioxide Laser in Melasma
Official title: Comparing Tranexamic Acid Microinjection Alone Versus Its Combination With Fractional Carbon Dioxide Laser in Melasma Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Melasma
Keywords: Melasma
Tranexamic acid
Fractional CO2 laser
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-04-02
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Melanin and Erythema indices change from baseline
timeFrame: baseline, 18 weeks and 20 weeks
measure: Dermoscopic features change from baseline
timeFrame: baseline, 18 weeks and 20 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.