Tranexamic Acid vs. Combination With Fractional Carbon Dioxide Laser in Melasma

Melasma Clinical Trial

Official title:

Comparing Tranexamic Acid Microinjection Alone Versus Its Combination With Fractional Carbon Dioxide Laser in Melasma Treatment

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03899233
• Other study ID #: Melasma treatment
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: April 1, 2019
• Est. completion date: November 1, 2019

Study information

• Verified date: March 2019
• Source: Cairo University
• Contact: Eman R Said, MD
• Phone: +201110066044
• Email: dremy07[@]cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: November 1, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Melanosis
• Melasma

Intervention

Device:
• Fractional CO2 laser
Low power fractional CO2 laser with a power of 12 watts, spacing 800 micrometer (7.3% density), and dwell time 300 microsecond

Drug:
• Tranexamic acid intradermal microinjections
Tranexamic acid 500mg/5ml ampules

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (4)

Jalaly NY, Valizadeh N, Barikbin B, Yousefi M. Low-power fractional CO2 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. — View 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. — View Citation

Tawfic SO, Abdel Halim DM, Albarbary A, Abdelhady M. Assessment of combined fractional CO(2) and tranexamic acid in melasma treatment. Lasers Surg Med. 2019 Jan;51(1):27-33. doi: 10.1002/lsm.23032. Epub 2018 Nov 15. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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