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IRCT20201204049589N1 IRCT 2021-03-02 Tehran University of Medical Sciences Evaluation of the effect of botulinum toxin and Profhilo hyaluronic acid injection in rejuvenation of the neck. Evaluation of the effect of botulinum toxin injection in comparison with botulinum toxin injection and PROFHILO hyaluronic acid in rejuvenation of the neck. 2019-08-23 anticipated 20 Complete https://irct.ir/trial/52780 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization method Using Random Allocation software, 20 patients are assigned to two groups of 10, Blinding description: In this study, physicians evaluating the outcome without knowing the patient's treatment group, based on a review of pre- and post-treatment photographs compared to the Wrinkle Assessment Scale, record their observational information. 2-3 Horizontal neck lines. Intervention 1: Control group: In 10 patients, Botulinum toxin (Dysport, IPSEN Company ) injection will be performed in the baseline visit according to the following protocol: 1 vial of Botox Dysport 500 units will be diluted with the addition of 2 and a half cc of normal saline. A 1 ml syringe with a 30 G needle will be used.In horizontal wrinkles, 1 to 2 intradermal injection units are performed at intervals of 1 to 2 cm. The maximum therapeutic dose is 70 units for the whole neck. Intervention 2: Intervention group: In 10 patients, Botulinum toxin (Dysport, IPSEN Company ) injection will be performed in the baseline visit according to the following protocol: 1 vial of Botox Dysport 500 units will be diluted with the addition of 2 and a half cc of normal saline. A 1 ml syringe with a 30 G needle will be used. In horizontal wrinkles, 1 to 2 intradermal injection units are performed at intervals of 1 to 2 cm. The maximum therapeutic dose is 70 units for the whole neck. 2 weeks later, Profhilo gel (IBSA Company) will be injected in these patients. The product is in the form of 2 ml syringes with 29G needle. The injection will be done transversely. 90 degree angle injection or deep platysmal injection should be avoided. The depth of the dermal injection will be deep dermis. The injection will be done at ten points and at each point 2 tenths of a cc. 1 month later, the 10 mentioned patients will receive the second time of Profhilo gel with the same technique. Yes - There is a plan to make this available What will be shared: All data can be shared after people have been unidentifiable. When: Access period starts 6 months after the results are published To whom: For researchers working in academic and scientific institutions Conditions: There are no other restrictions. Where to obtain: Dr Asma Jabbari jabbari.asma@gmail.com How to obtain: The data will be available via Email from the beginning of the publication of the results. Comments:
public Asma Jabbari
Razi Hospital,Vahdat E Eslami Ave
Tehran Iran (Islamic Republic of) 1199663911 +98 21 5516 9657 jabbari.asma@gmail.com Tehran University of Medical Sciences scientific Pedram Nourmohammad pour
Razi Hospital,Vahdat E Eslami Ave
Tehran Iran (Islamic Republic of) 119663911 21 009855169657 normohamad@razi.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Adults over 18 years and under 70 years Signing a voluntary agreement WSRS (Wrinkle Severity Rating Scale) between 4 - 2 They do not want to have a surgical procedure Patients who are not candidates for surgery 18 years 70 years Both Pregnancy and breastfeeding Neuromuscular diseases such as myasthenia gravis• Hypersensitivity to Botox or human albumin• Uncontrolled systemic disease Infection, scarring, abnormality at the injection site History of Botox injection or lower face filler in the last 12 months Patients treated with aspirin, immunosuppressants, narcotics, antiDepressants and corticosteroids in the last 3 months Treatment - Drugs Treatment - Drugs Control group: In 10 patients, Botulinum toxin (Dysport, IPSEN Company ) injection will be performed in the baseline visit according to the following protocol: 1 vial of Botox Dysport 500 units will be diluted with the addition of 2 and a half cc of normal saline. A 1 ml syringe with a 30 G needle will be used.In horizontal wrinkles, 1 to 2 intradermal injection units are performed at intervals of 1 to 2 cm. The maximum therapeutic dose is 70 units for the whole neck. Intervention group: In 10 patients, Botulinum toxin (Dysport, IPSEN Company ) injection will be performed in the baseline visit according to the following protocol: 1 vial of Botox Dysport 500 units will be diluted with the addition of 2 and a half cc of normal saline. A 1 ml syringe with a 30 G needle will be used. In horizontal wrinkles, 1 to 2 intradermal injection units are performed at intervals of 1 to 2 cm. The maximum therapeutic dose is 70 units for the whole neck. 2 weeks later, Profhilo gel (IBSA Company) will be injected in these patients. The product is in the form of 2 ml syringes with 29G needle. The injection will be done transversely. 90 degree angle injection or deep platysmal injection should be avoided. The depth of the dermal injection will be deep dermis. The injection will be done at ten points and at each point 2 tenths of a cc. 1 month later, the 10 mentioned patients will receive the second time of Profhilo gel with the same technique. Wrinkle severity rating scale (WSRS). Timepoint: The first visit and 6 months after Dysport injection and the second time filler. Method of measurement: Score based on the severity of wrinkles by comparing photography and dermoscopy before and after treatment. Skin hydration. Timepoint: Baseline visit and 6 months after the second filler injection in one group and one time of receiving dysport in the second group. Method of measurement: probe of the MP bolagen multi-adapter device(corporatereg number 5562201656) to measure hydration of the skin. Skin elasticity. Timepoint: Baseline visit and 6 months after the second filler injection in one group and one time of receiving dysport in the second group. Method of measurement: probe of the MP bolagen multi-adapter device(corporatereg number 5562201656). Water loss from the surface of the epidermis. Timepoint: Baseline visit and 6 months after the second filler injection in one group and one time of receiving dysport in the second group. Method of measurement: probe of the MP bolagen multi-adapter device(corporatereg number 5562201656). Pain during filler injection. Timepoint: During filler injection (two weeks after the first visit and one month after the second visit). Method of measurement: Patient self-expression form. Dermis and epidermis density. Timepoint: Baseline visit and 6 months after the second filler injection in one group and one time of receiving dysport in the second group. Method of measurement: Neck sonography. Dermis and epidermis thickness. Timepoint: Baseline visit and 6 months after the second filler injection in one group and one time of receiving dysport in the second group. Method of measurement: Neck sonography. IBSA Institue Biochemique SA Tehran University of Medical Sciences Paeezan Tejarat E Mehr company Approved 2020-05-17 Ethics committee of Tehran University of Medical Sciences Floor 5, Central Building of Tehran University of Medical Science, Qods St, Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)