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IRCT20230729058956N1 IRCT 2023-10-24 Shahed University effect of Irsa(Iris Germanica L.) topical product on melasma Evaluating the effect of Irsa(Iris Germanica L.) topical product on melasma 2023-09-23 anticipated 66 Complete https://irct.ir/trial/71860 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: Randomization is simple and each participant is randomly assigned to the treatment of the main intervention group or the treatment of the control group. The randomization unit is individual. Randomization tool: Excel software is used to generate random numbers and sealed envelopes. A code is assigned to each sealed envelope by the software, and one of these codes is randomly assigned to each participant by the software, and the corresponding envelope containing the medicine is delivered to the patient. The person who registers the codes in the software is different from the person who delivers the envelope to the patient. How to make a random sequence using a table of random numbers, Blinding description: The samples of the two intervention and control groups are not aware of the active substance inside the tubes due to the similarity of the tubes and the substance inside, and the pharmacist gives a code to each of them that only he knows, and the prescribing physician in the research plan is also not aware of the contents. And finally, after the end of the study, the appropriate medicine will be prescribed to the samples in accordance with the ethical principles of the research. Therefore, because the samples, the researchers and the analyst do not know, it will be blinded on three sides. 3 Melasma. Intervention 1: "Intervention group": includes people who receive Irsa cream. For 12 weeks, a thin layer of cream is applied on the spots in the morning and at night, and sunscreen is used during the day. Method of preparation of the cream: extraction is done from the rhizomes of the plant by the maceration method and using ethanol. After 72 hours, the resulting mixture is filtered and concentrated by rotary. The resulting liquid is completely dried and kept in a refrigerator at a temperature of 4 degrees Celsius until consumption. The extract is standardized in terms of total phenol and flavonoids. The cream is prepared with 5% of Irsa extract using cold cream as a cream base. The prepared cream is stored in 50 gram containers at refrigerator temperature. After using the cream, patients are examined every 4 weeks to 12 weeks and 4 weeks after the end of the treatment period, and the size of the spots is determined with the visio face device and the MASI SCORE index, and the color of the spots is measured with the German MPA CK megometer. The light of the room, the place of taking the photo, the place of measuring the color change of the spots, the angle of taking the photo are the same. In each visit, patients are evaluated in terms of drug consumption, improvement of lesions (size and color of lesions), disease progression, and occurrence of complications."Control group": includes people who receive hydroquinone cream. The creams in both groups are filled in unlabeled tubes. Intervention 2: "Control group": includes people who receive hydroquinone cream. The creams are filled in unlabeled tubes. For 12 weeks, patients apply a thin layer of cream on the spots in the morning and at night, and use sunscreen during the day. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals When: The access period starts 6 months after the results are published To whom: Researchers working in academic, scientific and research institutions Conditions: It is allowed to use the data for the purpose of meta-analyses and by preserving all the rights of the creators of this data. Where to obtain: By referring to the scientific officer of the research Ms. Dr. Maryam Iranzad Asl at the email address m_iranzadasl@yahoo.com and at the address of Shahed University, Fars Gulf Highway, Tehran, Tehran Province, Iran. zip code 3319118651. contact number 00982151214055. How to obtain: The applicant's request will be sent to the mentioned e-mail containing the applicant's profile,the purpose of receiving the data, and the details of the desired data, and it will be checked for compliance of the conditions and data requested with the publication conditions within a maximum of one month, and an appropriate response will be sent. Comments:
public masoomeh akhoondi ghahroodi
No. 14, Ashrafi Esfahani Street, Koche 21
Tehran Iran (Islamic Republic of) 1469915531 +98 21 4448 8342 masoomehakhoondi3@gmail.com Shahed University scientific Maryam Iranzad Asl
Persian Gulf Free way
Tehran Iran (Islamic Republic of) 3319118651 +98 21 5121 4055 m_iranzadasl@yahoo.com Shahed University Iran (Islamic Republic of) Women aged 18-60 years Having clear lesions of melasma with expert approval 18 years 60 years Female Pregnancy or breastfeeding Local or systemic treatment of melasma in the last 4 weeks Use of hormonal drugs (OCP and corticosteroids). L81.1 Chloasma Treatment - Drugs Treatment - Drugs "Intervention group": includes people who receive Irsa cream. For 12 weeks, a thin layer of cream is applied on the spots in the morning and at night, and sunscreen is used during the day. Method of preparation of the cream: extraction is done from the rhizomes of the plant by the maceration method and using ethanol. After 72 hours, the resulting mixture is filtered and concentrated by rotary. The resulting liquid is completely dried and kept in a refrigerator at a temperature of 4 degrees Celsius until consumption. The extract is standardized in terms of total phenol and flavonoids. The cream is prepared with 5% of Irsa extract using cold cream as a cream base. The prepared cream is stored in 50 gram containers at refrigerator temperature. After using the cream, patients are examined every 4 weeks to 12 weeks and 4 weeks after the end of the treatment period, and the size of the spots is determined with the visio face device and the MASI SCORE index, and the color of the spots is measured with the German MPA CK megometer. The light of the room, the place of taking the photo, the place of measuring the color change of the spots, the angle of taking the photo are the same. In each visit, patients are evaluated in terms of drug consumption, improvement of lesions (size and color of lesions), disease progression, and occurrence of complications."Control group": includes people who receive hydroquinone cream. The creams in both groups are filled in unlabeled tubes. "Control group": includes people who receive hydroquinone cream. The creams are filled in unlabeled tubes. For 12 weeks, patients apply a thin layer of cream on the spots in the morning and at night, and use sunscreen during the day. Color index of melasma lesions. Timepoint: Measurement of the color index of melasma lesions at the beginning of the study (before the start of the intervention) and 4،8،12،16 weeks after the start of the use of Irsa topical product. Method of measurement: Comparing the amount of skin darkening compared to healthy skin (natural skin color 0, brief darkness 1, mild darkness 2, moderate darkness 3, severe darkness 4) by observation, photography and megometer device. The extent of melasma lesions. Timepoint: Measuring the extent of melasma lesions at the beginning of the study (before the start of theintervention) and 4،8،12،16 weaks after the start of using the Irsa topica lproduct. Method of measurement: Calculating the area of the lesion using MASI score and VISIOFACE. Shahed University Approved 2023-07-17 Ethics Committee of Shahid University Persian Gulf Freeway Tehran Tehran Iran (Islamic Republic of)