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Trial record 3 of 18 for:    Recruiting, Not yet recruiting, Available Studies | Chloasma

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

Tracking Information
First Submitted Date  ICMJE March 21, 2019
First Posted Date  ICMJE April 2, 2019
Last Update Posted Date April 2, 2019
Estimated Study Start Date  ICMJE April 1, 2019
Estimated Primary Completion Date October 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 30, 2019)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tranexamic Acid vs. Combination With Fractional Carbon Dioxide Laser in Melasma
Official Title  ICMJE Comparing Tranexamic Acid Microinjection Alone Versus Its Combination With Fractional Carbon Dioxide Laser in Melasma 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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
Condition  ICMJE Melasma
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Device: Fractional CO2 laser
    • Drug: Tranexamic acid intradermal microinjections
  • 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.
    Intervention: Drug: Tranexamic acid intradermal microinjections
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 30, 2019)
25
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 1, 2019
Estimated Primary Completion Date October 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Eman R Said, MD +201110066044 dremy07@cu.edu.eg
Contact: Shereen O Tawfic, MD +201220085050 shereenosamat@yahoo.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03899233
Other Study ID Numbers  ICMJE Melasma treatment
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eman Raafat Said, Cairo University
Study Sponsor  ICMJE Cairo University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Cairo University
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP