]>
IRCT20220122053789N1 IRCT 2022-02-13 Iran University of Medical Sciences Evaluation of the effect of microneedling with tranexamic acid in combination with hydroquinone formula in comparison with either alone in the treatment of melasma Evaluation of the efficacy, safety and reliability of the effect of microneedling with tranexamic acid, in combination with a hydroquinone topical formula, in comparison with any of the treatments alone in patients with melasma: A randomized controlled clinical trial 2022-03-16 anticipated 50 Complete https://irct.ir/trial/61851 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are randomly divided into one of two groups A or B with an equal number by the randomization list prepared by the statistics specialist with specialized software. Each patient who have the inclusion criteria will be randomly admitted to one of the two treatment groups according to the randomization list. To choose which side of the face to be assigned to which of the two desired treatments, a simple random method will be performed by the doctor at the same time, Blinding description: The second physician and statistics specialist are blind to the group in which each patient is located and the type of treatment performed on each side of the patient's face. 2-3 Melasma. Intervention 1: Intervention group A: Patients use the Kligman-like topical formula on one side of the face every other day for 2 months and microneedling with 10% tranhexamic acid on the other side for 3 sessions at intervals of 1 month. Intervention 2: Intervention group B: Patients use the Kligman-like topical formula for both sides of the face every other day for 2 months and in addition, on one side of the face, microneedling with tranhexamic acid 10% and on the opposite side microneedling with tranhexamic acid 4% for 3 sessions at intervals of 1 month. 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 There is no further information
public Azadeh Goodarzi
Dermatology ward, Hazrat Rasool Akram hospital, Niayesh avenue, Satarkhan street, Tehran, Iran
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6651 7341 azadeh_goodarzi1984@yahoo.com Iran University of Medical Sciences scientific Azadeh Goodarzi
Dermatology ward, Hazrat Rasool Akram hospital, Niayesh avenue, Satarkhan street, Tehran, Iran
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6651 7341 azadeh_goodarzi1984@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) Age 18 to 60 years old Clinical diagnosis of bilateral melasma of the cheek 18 years 60 years Both Patients who have received any treatment for melasma in the past 1 month. Patients who have contraindications to tranexamic acid. (Includes known drug allergy, intracranial hemorrhage, known color vision disorder, history of arterial or venous thromboembolism or active thromboembolic disease, ischemic heart disease, and stroke) Patients with mental instability (which is expected to affect the study process). Patients who do not have informed consent to participate in the study. Patients who do not have the opportunity to visit regularly and cooperate for scoring and follow-up sessions. L81.1 Chloasma Treatment - Other Treatment - Other Intervention group A: Patients use the Kligman-like topical formula on one side of the face every other day for 2 months and microneedling with 10% tranhexamic acid on the other side for 3 sessions at intervals of 1 month. Intervention group B: Patients use the Kligman-like topical formula for both sides of the face every other day for 2 months and in addition, on one side of the face, microneedling with tranhexamic acid 10% and on the opposite side microneedling with tranhexamic acid 4% for 3 sessions at intervals of 1 month. Efficacy. Timepoint: One and two months after the start of treatment and one and four months after the end of treatment. Method of measurement: By modified Melasma Area & Severity Index and Visual Analogue Scale. Safety. Timepoint: One and two months after the start of treatment and one and four months after the end of treatment. Method of measurement: Ask from the patient for possible adverse effects. Satisfaction. Timepoint: One and two months after the start of treatment and one and four months after the end of treatment. Method of measurement: Based on patient scoring. Iran University of Medical Sciences Approved 2021-12-18 Ethics committee of Iran University of medical scinces Hazrat Rasool Akram hospital, Mansoori avenue, Sattarkhan street, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)