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IRCT20181226042136N2 IRCT 2020-08-31 Esfahan University of Medical Sciences Evaluation of the effect of mesotherapy in the treatment of hair loss Evaluation of the effect of mesotherapy with a combination of biotin and dexpanthenol in the treatment of androgenetic alopecia in women 2020-04-19 anticipated 36 Complete https://irct.ir/trial/50577 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are placed in random groups using Random Allocation software and Block Randomization method and all patients are unaware of their grouping, Blinding description: First, patients are randomly divided into two groups. Patients, researchers and, evaluators will not be aware of the treatment groups, Medications are given to patients without a name and specification. Information will be provided to surveyors in the form of questionnaires delivered to the evaluators. The data is given for analysis as encoded and unnamed groups and profiles to the information analyzer. 3 female androgenetic alopecia. Intervention 1: Intervention group: In the case group, patients undergoing mesotherapy with microneedling with a solution of 20 mg of biotin + 500 mg of dexpanthenol per month plus topical minoxidil 2% twice a day. The duration of the treatment period is 16 weeks. The volume of the substance used in each injection session is 3 cc. After disinfecting the vortex, first microneedling will be done with a 12-needle microneedle needle with a depth of 1.5 cm. Then, the desired materials in each group will be applied on the microneedle site and the patient's head will be bandaged. Intervention 2: Control group: In the control group, normal saline is used as a placebo and patients also receive 2% topical minoxidil twice a day in addition to mesotherapy with normal saline microneedling. The duration of the treatment period is 16 weeks. The volume of the substance used in each injection session is 3 cc. After disinfecting the vortex, first microneedling will be done with a 12-needle microneedle needle with a depth of 1.5 cm. Then, the desired materials in each group will be applied on the microneedle site and the patient's head will be bandaged. Yes - There is a plan to make this available What will be shared: The primary outcome data will be shared When: Start the access period is 6 months after publishing the results To whom: Academic researchers Conditions: The request can be made by e-mail to the corresponding author Where to obtain: It can be done by e-mail to z.ganjei@gmail.com How to obtain: Once the applicant has provided details of their ongoing project within one month from the time of application data will be available. Comments:
public Zakiye Ganjei
hezar jerib
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 7270 z.ganjei@gmail.com Esfahan University of Medical Sciences scientific Zakiye Ganjei
Hezar Jerib
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 7270 z.ganjei@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Having a female pattern hair loss Do not use other hair loss treatments at the time of enrollment Do not use temporary and permanent hair dye and curl or straighten hair Do not use aspirin, warfarin, steroids, oral retinoids, hormones or cytotoxic drugs Absence of pregnancy and lactation Absence of high androgenic blood levels, irregular periods, acne and hirsutism, thromboembolic events, low ferritin blood levels and impaired TSH 18 years 45 years Female Allergic reaction to the drug used Failure to complete the course of treatment and failure to refer for follow-up, which results in a drawing on the case file or the patient Local reactions such as abscesses, inflammation and cellulite at the injection site The patient's decision not to participate in the study L64 Androgenic alopecia Treatment - Drugs Placebo Intervention group: In the case group, patients undergoing mesotherapy with microneedling with a solution of 20 mg of biotin + 500 mg of dexpanthenol per month plus topical minoxidil 2% twice a day. The duration of the treatment period is 16 weeks. The volume of the substance used in each injection session is 3 cc. After disinfecting the vortex, first microneedling will be done with a 12-needle microneedle needle with a depth of 1.5 cm. Then, the desired materials in each group will be applied on the microneedle site and the patient's head will be bandaged. Control group: In the control group, normal saline is used as a placebo and patients also receive 2% topical minoxidil twice a day in addition to mesotherapy with normal saline microneedling. The duration of the treatment period is 16 weeks. The volume of the substance used in each injection session is 3 cc. After disinfecting the vortex, first microneedling will be done with a 12-needle microneedle needle with a depth of 1.5 cm. Then, the desired materials in each group will be applied on the microneedle site and the patient's head will be bandaged. Appearance based on photography. Timepoint: Photographs will be taken first before the start of treatment and finally two weeks after the microneedling sessions. Method of measurement: By a dermatologist. Intensity based on Ludwig Griding. Timepoint: It is performed before treatment and at 18 weeks by a dermatologist who is unaware of the patient's grouping. Method of measurement: By a dermatologist. Number of hairs plucked in the hair pulling test. Timepoint: The number of hairs removed before treatment and after 18 weeks is counted and recorded. Method of measurement: In the hair pull test, about 20-30 hairs in the vortex area between the thumb and the other 4 fingers are gently pulled and pulled vertically. Patient opinion about density, thickness, hair loss and quality. Timepoint: before and after the treatment. Method of measurement: In the self-assessment of the patient, the result of the treatment is asked about increasing hair density, increasing hair thickness, hair loss rate and hair quality (color and transparency). Answers are considered as worsening 1-, without changing 0 and improving 1. Complications. Timepoint: In each session. Method of measurement: Complications of treatment in each session, including headache, cramping, itching, ecchymosis, puffy eyes, increased hair growth in other parts of the body and changes in menstrual patterns, patients are asked and recorded. Esfahan University of Medical Sciences Approved 2020-05-26 Ethics committee of Isfahan University of Medical Sciences Hezar-Jerib Isfahan Isfehan Iran (Islamic Republic of)