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IRCT20211206053302N1 IRCT 2022-01-17 Tabriz University of Medical Sciences Evaluation of the effect of wheat on skin rejuvenation in women Evaluation of the effectiveness of wheat callus extract in rejuvenation and reduction of skin wrinkles with clinical evaluation in volunteers 2022-01-30 anticipated 48 Complete https://irct.ir/trial/60844 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Other design features: In this study, all 24 volunteers will use the drug on the right side of the face around the right eye and the placebo on the other side of the face symmetrically, and the effect of the drug and the placebo on reducing wrinkles around the eyes will be compared. 2-3 Wrinkles - Skin aging. Intervention 1: Intervention group: Evaluation of the effect of wheat callus extract containing polyphenols, phenolic acid, flavonoids, triterpenes, carotenoids and peptides, in the form of nanoliposomal gel formulation with a concentration of 0.2% for daily topical use (50 mg of Pure active ingredient) once daily for 6 months on the right side of the face (around the right eye) on 24 female volunteers. All stages of preparation of this drug (including culture and preparation of callus and extraction and preparation of nanoliposome formulation and gel form) will be performed by the researcher and no company or organization will have a role in its preparation. Intervention 2: Control group: Evaluation of the effect of drug-free nanoliposomes in gel formulation, once daily topically as a placebo for 6 months on the left side of the face (around the left eye) on 24 female volunteers. All stages of preparation of this drug (including culture and preparation of callus and extraction and preparation of nanoliposome formulation and gel form) will be performed by the researcher and no company or organization will have a role in its preparation. 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 more information
public Ehsan Adhami
Medical Education Research and Development Complex (formerly Pashmineh), Pharmaceutical Nanotechnology Research Center., Opposite to Shahid Madani Hospital.,University St.
Tabriz Iran (Islamic Republic of) 5165665811 +98 41 3335 5389 adhamiehsan@gmail.com Tabriz University of Medical Sciences scientific Dr.Hamed Hamishekar
Medical Education Research and Development Complex (formerly Pashmineh), Pharmaceutical Nanotechnology Research Center., Opposite to Shahid Madani Hospital.,University St.
Tabriz Iran (Islamic Republic of) 5165665811 +98 41 3335 5389 hamishehkar.hamed@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Women with facial wrinkles in the desired areas age of 30 to 55 years 30 years 55 years Female History of previous allergies to cosmetics Estrogen therapy Simultaneous use of anti-wrinkle products in the desired area Pregnancy and lactation History of cardiovascular disease, diabetes, hypothyroidism or hyperthyroidism R23.8 Other skin changes Treatment - Other Placebo Intervention group: Evaluation of the effect of wheat callus extract containing polyphenols, phenolic acid, flavonoids, triterpenes, carotenoids and peptides, in the form of nanoliposomal gel formulation with a concentration of 0.2% for daily topical use (50 mg of Pure active ingredient) once daily for 6 months on the right side of the face (around the right eye) on 24 female volunteers. All stages of preparation of this drug (including culture and preparation of callus and extraction and preparation of nanoliposome formulation and gel form) will be performed by the researcher and no company or organization will have a role in its preparation. Control group: Evaluation of the effect of drug-free nanoliposomes in gel formulation, once daily topically as a placebo for 6 months on the left side of the face (around the left eye) on 24 female volunteers. All stages of preparation of this drug (including culture and preparation of callus and extraction and preparation of nanoliposome formulation and gel form) will be performed by the researcher and no company or organization will have a role in its preparation. Comparison of the effect of wheat extract on skin rejuvenation and reduction of depth, size and number of facial wrinkles. Timepoint: At the beginning of the study and 3 and 6 months after the start of the trial. Method of measurement: Facial photos and scoring by a dermatologist. Tabriz University of Medical Sciences Approved 2021-11-15 Ethics committee of Tabriz University of Medical Sciences Medical Education Research and Development Complex (formerly Pashmineh), Pharmaceutical Nanotechnology Research Center., Opposite of Shahid Madani Hospital.,University St. Tabriz East Azarbaijan Iran (Islamic Republic of)