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

NCT03899233 | Unknown Phase 4

• 1 other identifier: Melasma treatment
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Melasma

Keywords

Melasma; Tranexamic acid; Fractional CO2 laser

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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.

Device: Fractional CO2 laser; Drug: Tranexamic acid intradermal microinjections

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.

Drug: Tranexamic acid intradermal microinjections

Interventions

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

Fractional CO2 laser combined with Tranexamic acid

Tranexamic acid intradermal microinjections DRUG

Tranexamic acid 500mg/5ml ampules

Fractional CO2 laser combined with Tranexamic acid; Tranexamic acid alone

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with bilateral symmetrical facial melasma

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Related Publications (4)

• 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.

  PMID: 30431171 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.

  PMID: 20514787 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.

  PMID: 24858737 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.

  PMID: 29027510 BACKGROUND

MeSH Terms

Conditions

Melanosis

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Eman R Said, MD

CONTACT

+201110066044; dremy07@cu.edu.eg

Shereen O Tawfic, MD

CONTACT

+201220085050; shereenosamat@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Dermatology Department, Faculty of Medicine

Model Details: 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.

Study Record Dates

• First Submitted: March 21, 2019
• First Posted: April 2, 2019
• Study Start: April 1, 2019
• Primary Completion: October 1, 2019
• Study Completion: November 1, 2019
• Last Updated: April 2, 2019

Record last verified: 2019-03