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IRCT20220609055116N1 IRCT 2023-07-23 Shiraz University of Medical Sciences Clinical assessment of the efficacy of topical nano-formulation of tranexamic acid/niacinamide in melasma Clinical assessment of the efficacy of tranexamic acid-niacinamide loaded niosome in comparison to tranexamic acid-niacinamide and hydroquinone conventional creams in melasma 2023-08-06 anticipated 102 Complete https://irct.ir/trial/67780 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly divided into 3 treatment groups through the block randomization technique using Sealed Envelope software. Sealed Envelope software is used for block randomization of the samples. In this regard, the sample size (102 patients), the block size (6), and the number of treatment groups (3 groups) will be given to the software. Then, according to the inputs, a total of 102 patients will be randomly divided into 17 blocks and each block will contain 6 individuals. In addition, each block will contain an equal number of each treatment type. After that, through the Sealed Envelope software, a specified code number (ex. NB4) will be assigned to each patient. After formulation preparation according to the suggested blocks, each formulation will be put in an envelope and sealed, and then marked with a specified code number. The prepared sealed envelopes will be grouped in the aforementioned blocks and will be given to the physician. Each sealed envelope that is marked with a specified code number will be randomly allocated to each participant entered in the trial by the physician. So, the Sealed Envelope software will be used as a randomization tool and allocation concealment would be achieved through the sealed envelopes and specified codes that will be assigned to each participant. Only the principle investigator and the formulator will be aware of the treatment type of each sealed envelope and specified code number, while others are blinded, Blinding description: In this study, all participants, the physician who will visit the patients and assess the response to therapy sequentially, those who will give the formulations to the patients, the statistical analyst, and the outcome analyzer will be blinded. However, the principle investigator, Safety Monitoring Board, the researcher who prepared the formulations, and the manuscript writers will be unblinded. It should be mentioned that all patients will be aware of the clinical trial and will be included in this study just after signing the informed consent form. Blinding will be performed through the recruitment of the suggested specified code numbers by the Sealed Envelope software. In this regard, each treatment (topical formulation) would be put in an envelope and sealed, and marked with a specified code number from the software. After that, the sealed envelopes will be further grouped in blocks. The prepared sealed envelopes that are grouped in 17 blocks (each block contains 6 envelopes) will be given to the physician. The physician will randomly allocate each sealed envelope to each participant who entered the trial. Therefore, only the principle investigator, Safety Monitoring Board, and the formulator will be aware of the treatment type of each specified code number of sealed envelopes, while the others are blinded. 2-3 Melasma. Intervention 1: First group: Patients receiving topical niosomal tranexamic acid %2-niacinamide %2 formulation twice daily for 3 months. Intervention 2: Second group: Patients receiving topical tranexamic acid %5-niacinamide %4 conventional cream twice daily for 3 months. Intervention 3: Positive control group: Patients receiving topical hydroquinone %4 conventional cream at night (and blinded-label cold cream in the morning) for 3 months. Yes - There is a plan to make this available What will be shared: All gathered deidentified individual participant data (IPD) would be shared where necessary. When: Data would be available after the collection of required data from all participants or when any severe adverse reaction occurred. Data would be available at least for 5 years after the completion of this study. To whom: Data would be available to healthcare authorities. Conditions: Data would be available on request. Where to obtain: Data would be available through direct communication with the project administrator. How to obtain: Data would be available through direct communication with the project administrator. (Email address: smsamani@sums.ac.ir) Comments:
public Prof. Soliman Mohammadi-Samani
School of Pharmacy, Karafarin Street, Shiraz-Isfahan Hyw, Shiraz.
Shiraz Iran (Islamic Republic of) 7146864685 +98 71 3242 4128 smsamani@sums.ac.ir Shiraz University of Medical Sciences scientific Prof. Soliman Mohammadi-Samani
School of Pharmacy, Karafarin Street, Shiraz-Isfahan Hwy., Shiraz.
Shiraz Iran (Islamic Republic of) 7146864685 +98 71 3242 4128 smsamani@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Patients (Male/female) with melasma between 18 and 50 years old Patients who have had melasma for at least 6 months ago Patients who are capable to understand, read, and write the informed consent form Patients who are able to participate in periodic follow-up visits by physician 18 years 50 years Both Patients who have received oral contraceptive (OCP) therapy within 3 months prior to the study initiation or during the study Patients who are receiving oral corticosteroids or applying topical corticosteroids on melasma lesions during the study Patients with a history of thyroid disease Patients with a history of intolerance, hypersensitivity reactions, or severe irritation to hydroquinone, tranexamic acid, or niacinamide, Patients with other hyperpigmentary disorders Pregnancy or lactation Patients who have received any pharmacologic or procedural treatment within 2 months prior to the study initiation L81 Other disorders of pigmentation Treatment - Drugs Treatment - Drugs Treatment - Drugs First group: Patients receiving topical niosomal tranexamic acid %2-niacinamide %2 formulation twice daily for 3 months Second group: Patients receiving topical tranexamic acid %5-niacinamide %4 conventional cream twice daily for 3 months Positive control group: Patients receiving topical hydroquinone %4 conventional cream at night (and blinded-label cold cream in the morning) for 3 months In each follow-up, standard skin photography will be performed from the left, right, and front sides of the faces of the patients using Visioface 1000D instrument (CK Electronic, Germany) and modified melasma area and severity (mMASI) score, as a major assessment tool in melasma, will be calculated accordingly. Timepoint: Clinical responses to the topical treatment will be assessed every 4 weeks up to 3 months in patients with melasma. Method of measurement: Modified MASI score = 0.3 × Area (forehead) × Darkness (forehead) + 0.3 × Area (left malar) × Darkness (left malar) + 0.3 × Area (right malar) × Darkness (right malar) + 0.1 × Area (chin) × Darkness (chin). Patients' quality of life will be assessed through the Melasma Quality of Life Scale (MELASQOL) questionnaire. Timepoint: Patients' quality of life will be assessed before treatment initiation and also at the end of the study (after 3 months of treatment). Method of measurement: Patients' quality of life will be assessed through the Melasma Quality of Life Scale (MELASQOL) questionnaire in which validity and reliability are confirmed. Shiraz University of Medical Sciences Approved 2023-04-24 Ethics Committee of Shiraz University of Medical Sciences Ethics Committee, Vice Chancellor for Research, Administrative Buiding of Shiraz University of Medical Sciences, Zand Blvd, Shiraz, Iran Shiraz Fars Iran (Islamic Republic of)