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

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ClinicalTrials.gov Identifier: NCT03899233
Recruitment Status : Not yet recruiting
First Posted : April 2, 2019
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
Eman Raafat Said, Cairo University

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.


Condition or disease Intervention/treatment Phase
Melasma Device: Fractional CO2 laser Drug: Tranexamic acid intradermal microinjections Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparing Tranexamic Acid Microinjection Alone Versus Its Combination With Fractional Carbon Dioxide Laser in Melasma Treatment
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : November 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Fractional CO2 laser combined with Tranexamic acid
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
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

Active Comparator: Tranexamic acid alone
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
Tranexamic acid 500mg/5ml ampules




Primary Outcome Measures :
  1. Melanin and Erythema indices change from baseline [ Time Frame: 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.

  2. Dermoscopic features change from baseline [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03899233


Contacts
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Contact: Eman R Said, MD +201110066044 dremy07@cu.edu.eg
Contact: Shereen O Tawfic, MD +201220085050 shereenosamat@yahoo.com

Sponsors and Collaborators
Cairo University

Publications:
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Responsible Party: Eman Raafat Said, Lecturer of Dermatology Department, Faculty of Medicine, Cairo University
ClinicalTrials.gov Identifier: NCT03899233     History of Changes
Other Study ID Numbers: Melasma treatment
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Eman Raafat Said, Cairo University:
Melasma
Tranexamic acid
Fractional CO2 laser

Additional relevant MeSH terms:
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Melanosis
Hyperpigmentation
Pigmentation Disorders
Skin Diseases
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants