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IRCT20141007019432N7 IRCT 2018-06-10 Tehran University of Medical Sciences Preperation and characterization of lipospmal Epidermal growth factor and evaluating its efficacy on preorbital wrinkles --- Preparation and characterization of lipospmal Epidermal growth factor and evaluating its efficacy on preorbital wrinkles 2018-07-23 anticipated 15 Complete https://irct.ir/trial/30378 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: ------, Randomization description: Randomisation Tool: Plumbed Envelope Two groups A, B are placed in the plumbed envelope. In Group A, the liposomal growth factor production is used on the right side and the left side of the placebo and group B the right side of the placebo and the left side of the Liposomal growth factor production is used, Blinding description: In this double blind study , participants and analyser are unaware of the allocation of study groups. 1 Aging and preorbital wrinkle. Intervention 1: Intervention group:In this study, 15 patients with the same conditions of entry are matched with t skin and stem cells research center . wrinkles around the eye on one of the side face are considered as intervention and the other site as a control. The topical cream application is used for 3 months for twice a day ( morning and night). evaluating the efficacy of the cream, by the biometric factors are examined once before the intervention and then 3 months later. Fallow up is done until the 6th month. Intervention 2: Control group:The control group in this study is the same as participating in intervention, one side of the face being considered as a control. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Dr. Mohammadamir Amirkhani
Skin and Stem Cell Research Center in Tehran University of Medical Sciences ,Maryam deadend,sough Kamranieh ,Tehran Iran
Tehran Iran (Islamic Republic of) 1937957511 +98 22201710 amirkhani2000@yahoo.com Tehran University of Medical Sciences scientific Dr.Masoud Ahmadvand
Faculty Paramedicine ,Iran University,Tehran Iran
Tehran Iran (Islamic Republic of) 141556183 +98 21 8670 4601 d.ahmadvand@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Aged between 35 to 50 years old. Having a healthy face for dermatological, anatomical and sympathetic diseases Being in the wrinkle grade 2 and 3 according to the Lemperle 4 table Having psychological and social health (based on self-expression) Having knowledge And have enough time to cooperate until the end of the plan 35 years 50 years Both Without any restorative intervention in the form of sub-sission , botox, filler, lift and surgery and etc, Having plenty of wrinkles in different areas of the skin Mental and social obsessive-compulsive disorder (based on self-declaration) history of related skin diseases, autoimmune, allergies or inflammation near the site history of prematurity cardiovascular, respiratory, diabetes, wound healing, moderate to high anemia, and other diseases that affect the process of rejuvenation history of systemic diseases history of oral and maxillofacial infections positive screening tests HIV1.2Ab, HBsAg, HbcAb, HCVAb, Treatment - Other Treatment - Other Intervention group:In this study, 15 patients with the same conditions of entry are matched with t skin and stem cells research center . wrinkles around the eye on one of the side face are considered as intervention and the other site as a control. The topical cream application is used for 3 months for twice a day ( morning and night). evaluating the efficacy of the cream, by the biometric factors are examined once before the intervention and then 3 months later. Fallow up is done until the 6th month. Control group:The control group in this study is the same as participating in intervention, one side of the face being considered as a control. Effect of liposomal epidermal growth factor production on the surface and depth of preorbital wrinkle. Timepoint: before intervention and 3 months after using. Method of measurement: The statistical population is according to the degree of wrinkles 2 and 3 in thecase of women aged between 35 and 50 years that are selected by written consent. In this study, viscosity of the skin with visioface (D1000 ck Cologne, Germany), the level and degree of wrinkle with the set (LL 650 CK Germany), the thickness and density of the skin, the dermal and epidermal with ultrasound skin scanner, DUB-TPA EOTECH, Marcoussis, France), Multiprobe , elasticity with Adapter Cutometer (Cologne, Germany) ,skin water levels by chronometer devices are examined before and after using cream for 3 months and the numbers will be compared. All statistical analyses will be done in SPSS software. Effect of liposomal epidermal growth factor production on moisture ,elasticity and dermal -epidermal thickness,. Timepoint: before intervention and 3 months after using. Method of measurement: The statistical population is according to the degree of wrinkles 2 and 3 in thecase of women aged between 35 and 50 years that are selected by written consent. In this study, viscosity of the skin with visioface (D1000 ck Cologne, Germany), the level and degree of wrinkle with the set (LL 650 CK Germany), the thickness and density of the skin, the dermal and epidermal with ultrasound skin scanner, DUB-TPA EOTECH, Marcoussis, France), Multiprobe , elasticity with Adapter Cutometer (Cologne, Germany) ,skin water levels by chronometer devices are examined before and after using cream for 3 months and the numbers will be compared. All statistical analyses will be done in SPSS software. Tehran University of Medical Sciences Approved 2018-01-10 Tehran University of Medical Sciences Tehran University of Medical Sciences Cross Qods st , Keshavarz Blvd, Tehran ,Iran Tehran Tehran Iran (Islamic Republic of)