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IRCT20191213045719N1 IRCT 2020-01-26 Ahvaz University of Medical Sciences "Effect of Ascorbic acid in treatment of melasma" Comparison of the Effectiveness of intradermal injected tranexamic acid50mg/ml plus ascorbic acid50mg/ml VS tranexamic acid50mg/ml in the treatment of melasma:A split face comparative trial 2019-11-23 anticipated 24 Complete https://irct.ir/trial/44216 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization will be done by coin toss.The coin will be thrown into the air several times (based on the number of study samples) and we will check which side is showing when it will land.If it will land from the head,righte side of the face will put in groupe A(tranxamic acid and ascorbic acid) and if it will land on the tail, righte side of the face will put in groupe B(tranxamic acid and placebo).left side of the face.Then left side of the face will put in the other groupe, Blinding description: Due to the uniformity of the color and similarity of the appearance of the injected medication, participants and value assessment will be blinded to the medication given at any side of their faces. 3 Melasma. Intervention 1: Intervention group: One side of the face is injected with Tranexamic acid 50 mg / ml and Ascorbic acid 50 mg / ml is given intradermally every other week for 12 weeks. Intervention 2: Control group: The other side of the face is injected with tranexamic acid 50 mg / ml intradermaly every other week for 12 weeks.Tranexamic acid is available in 500 mg ampoules at 5 cc. Ascorbic acid is available in 500 mg ampoules at 5 cc. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is "No more information"
public Doctor Seyedeh Nasrin Molavi
Dr Maashi office, Zaminha Ave, Kooye Abazar Ave, Bandar Imam Khomeini Town
Bandar Imam Khomeini Iran (Islamic Republic of) 6356144731 098 61 52223968 Molavi.n@ajums.ac.ir Ahvaz University of Medical Sciences scientific Doctor Nader Pazyar
Imam khomeini hospital, Dermatology clinic, Azadegan Ave
Ahwaz Iran (Islamic Republic of) 6193673111 +98 61 3292 1873 Dr.Pazyar@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Women at the range of 18 to 50 years old patients with symmetrical bilateral melasma 18 years 50 years Female Patient who is pregnant or in lactation period Patient who had taken oral contraceptive pill in 12 months ago Patient who has history of coagulopathy and thrombotic disorder Patient who ia taking anticoagulant and antiepileptic drug Patient who has sensitivity to tranexamic acid Patient who has history of treatment for melasma during 1 month ago Patient who has active facial herpes simplex virus infection Patient who has facial wart L81.1 Chloasma Treatment - Drugs Treatment - Drugs Intervention group: One side of the face is injected with Tranexamic acid 50 mg / ml and Ascorbic acid 50 mg / ml is given intradermally every other week for 12 weeks. Control group: The other side of the face is injected with tranexamic acid 50 mg / ml intradermaly every other week for 12 weeks.Tranexamic acid is available in 500 mg ampoules at 5 cc. Ascorbic acid is available in 500 mg ampoules at 5 cc. Melasma area and severity index. Timepoint: Melasma area and severity index measured at base of trial and 4, 8, 12 and24 weeks of trial. Method of measurement: Melasma area and severity index. Patient satisfaction. Timepoint: Measuring of patient satisfaction in 4, 8, 12 and 24 weeks of trial. Method of measurement: Satisfaction percentage questionnaire. Ahvaz University of Medical Sciences Approved 2019-11-23 Ethics committee of Ahwaz Jondishapur University of Medical Sciences Vice Chancellor for Research, Ahwaz Jundishapur University of Medical Sciences; Golestan Blvd Ahwaz Khouzestan Iran (Islamic Republic of)