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IRCT20191106045356N17 IRCT 2023-07-24 Yazd University of Medical Sciences Evaluation of the effect of glycyrrhizin hydrogel on laser burns Preparation and evaluation of topical glycyrrhizin-menthol-aloe vera gel and assessment its effect on the prevention of laser-induced dermatitis: a randomized controlled clinical trial 2023-04-09 anticipated 60 Complete https://irct.ir/trial/69022 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: This study is a randomized clinical trial that is conducted on 60 patients at Yazd Laser Therapy Center. Taking into account the inclusion criteria, the participants will be randomly placed in three groups of 20 people including glycyrrhizin gel recipient, gel base, and control (without receiving any medication), and will receive the drug related to that group, based on the RAND() function of Excel software. The medicine is placed in uniform containers, and neither the doctor nor the participant knows about the contents of the tubes, Blinding description: In this study, clients who have undergone laser hair removal will be included in the study after obtaining written consent. Taking into account the inclusion criteria, the clients will be placed in 3 groups of 30 people including glycyrrhizin-menthol-aloe vera gel, placebo (base gel) or control (without medicine) based on the random numbers table. They will use the prescribed medicine twice a day under the supervision of a doctor. Neither the doctor nor the patient knows the contents of the medicine containers. After the start of the treatment at times 1, 2, 4, 7, 10, 15, the state of the laser site in terms of the loss of the epidermis, intensity of redness, dryness, itching (based on the table below), burning and pain (based on the visual scale VAS) and the patient's satisfaction with the use of the drug and whether the skin in the laser area gets second degree burns or not and the need to use standard dermatitis treatment are evaluated. 3 Laser induced dermatitis. Intervention 1: Intervention group: The recipient of glycyrrhizin-menthol-aloe vera gel will use the prescribed medicine twice a day under the supervision of a doctor. In this study, clients who have undergone laser hair removal will be included in the study after obtaining written consent. Taking into account the criterion of entry into the study, the clients will be placed in 3 groups of 30 people including glycyrrhizin-menthol-aloe vera gel (prepared at the Faculty of Pharmacy of Yazd University of Medical Sciences under the supervision of the professors of the faculty and as a doctoral thesis of a pharmacy student), placebo (base gel) or control (without medicine). Twice a day and for 15 days under the supervision of a doctor, they will use the prescribed medicine topically. Neither the doctor nor the patient knows the contents of the medicine containers. After starting the treatment at times 1, 2, 4, 7, 10, 15, the condition of the laser site in terms of the loss of the epidermis, the intensity of redness, dryness, itching (based on the table below), burning and pain (based on the visual analog scale), and the patient's satisfaction with the use of the drug, and whether the skin of the laser area is subject to second-degree burns or not, and the need to use standard dermatitis treatment, are evaluated. Intervention 2: Control group: Placebo (base gel) or control (without medicine) which is filled in tubes like medicine. Yes - There is a plan to make this available What will be shared: Only a part of the data, such as the information related to the main outcome or the like, can be shared. When: One year after the time of publication To whom: The data will be available only to researchers working in academic and scientific institutions Conditions: The data will be available only to researchers working in academic and scientific institution Where to obtain: The data will only be available to researchers working in academic and scientific institutions through the following email address. neginaseri@yahoo.com How to obtain: Only the data related to the main results of the study can be presented to the mentioned people after mentioning the valid reason. Comments:
public Fatemeh Dehghani
Faculty of Pharmacy , Yazd , Alem square
Yazd Iran (Islamic Republic of) 1234567890 +98 913 776 2437 fatemehdehqani978@yahoo.com Yazd University of Medical Sciences scientific Fatemeh Dehghani
Faculty of Pharmacy, Yazd, Alam Square
Yazd Iran (Islamic Republic of) 1234567890 +98 913 776 2437 fatemehdehqani978@yahoo.com Yazd University of Medical Sciences Iran (Islamic Republic of) Clients starting to use laser Clients aged 18 to 55 years No history of licorice allergy Absence of severe systemic disease such as uncontrolled diabetes, epilepsy, immune system deficiency, etc. Willingness to participate in the study and complete the ethical consent form 18 years 55 years Both Clients with skin disease Allergy to glycyrrhizin or any of the compounds used Exacerbation of dermatitis or 2nd degree burns Non-cooperation of the volunteer in using medicine for more than one day L59.8 Other specified disorders of the skin and subcutaneous tissue related to radiation Prevention Prevention Intervention group: The recipient of glycyrrhizin-menthol-aloe vera gel will use the prescribed medicine twice a day under the supervision of a doctor. In this study, clients who have undergone laser hair removal will be included in the study after obtaining written consent. Taking into account the criterion of entry into the study, the clients will be placed in 3 groups of 30 people including glycyrrhizin-menthol-aloe vera gel (prepared at the Faculty of Pharmacy of Yazd University of Medical Sciences under the supervision of the professors of the faculty and as a doctoral thesis of a pharmacy student), placebo (base gel) or control (without medicine). Twice a day and for 15 days under the supervision of a doctor, they will use the prescribed medicine topically. Neither the doctor nor the patient knows the contents of the medicine containers. After starting the treatment at times 1, 2, 4, 7, 10, 15, the condition of the laser site in terms of the loss of the epidermis, the intensity of redness, dryness, itching (based on the table below), burning and pain (based on the visual analog scale), and the patient's satisfaction with the use of the drug, and whether the skin of the laser area is subject to second-degree burns or not, and the need to use standard dermatitis treatment, are evaluated. Control group: Placebo (base gel) or control (without medicine) which is filled in tubes like medicine. Grading the intensity of skin redness. Timepoint: After starting treatment at times 1, 2, 4, 7, 10, 15. Method of measurement: The condition of the laser site in terms of the loss of the epidermis, the intensity of redness, dryness, itching, burning, and pain (based on the visual analog scale), and the patient's satisfaction with the use of the drug, and that the skin of the laser area has undergone second-degree burns. are evaluated or not, as well as the need to use the standard treatment of dermatitis. Yazd University of Medical Sciences Approved 2023-01-11 The ethics committee of Shahid Sadoughi University of Medical Sciences Faculty of Pharmacy, Shahid Sadoughi University of Medical Sciences Yazd Yazd Iran (Islamic Republic of)