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IRCT20201210049671N1 IRCT 2021-04-08 Tehran University of Medical Sciences Effectiveness of Profhilo on Acne scar. Evaluating the effectiveness of subcision in combination with Profhilo in comparison with subcision filler injection alone on acne scar among patients treated at the dermatology clinic 2021-03-04 anticipated 12 Complete https://irct.ir/trial/53053 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: the face of each individual will be designated to two sides of right and left and for a different procedure in each side. Any procedure will be done by block randomization using a software, Blinding description: The patients and the treating physician are aware about the side of procedures. But informations about the specific procedures on each side of the face will be withheld from the sonographist and final image analysers. 3 Atrophic acne scar. Intervention 1: Intervention group: The randomized site of the face will undergone subcision and intradermal Profhilo filler injection, and will be repeated after 1 month. Intervention 2: Control group: The opposite side will undergone submission only and will be repeated after 1 month. Yes - There is a plan to make this available What will be shared: All data will be accessible for academic researchers after covering the identities. When: After journal publishment, all data will be accessible for ever. To whom: For all academic researchers in the field of medicine and pharmacology. Conditions: Just for using in research fields and respecting the original researchers in any references. Where to obtain: Calling the main researchers using this email: mani.dastgheib@gmail.com How to obtain: Just an email containing information about the academic position of the researchers and their responsibilities. Comments:
public Kamran Balighi
Razi Hospital, Razi alley, Vahdat Eslami Square
Tehran Iran (Islamic Republic of) 1199663911 +98 21 5563 0223 kamran.balighi@yahoo.com Tehran University of Medical Sciences scientific Kamran Balighi
Razi Hospital, Razi alley, Vahdat Eslami Square
Tehran Iran (Islamic Republic of) 1199663911 +98 21 5563 0223 kamran.balighi@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Adults aging between 18-40 Presence of bilateral atrophic acne scar Being a potential candida for subcision procedure Informed consent and patient agreement for participation No previous procedure in last 3 months 18 years 40 years Both Previous filler injection in the intervening site Coagulation disorder Autoimmune diseases Infection at the site Allergy to hyalouronic acid products Pregnancy and breast feeding Isotretinoin consumption during last 6 months L70 Acne Treatment - Other Treatment - Surgery Intervention group: The randomized site of the face will undergone subcision and intradermal Profhilo filler injection, and will be repeated after 1 month. Control group: The opposite side will undergone submission only and will be repeated after 1 month. Acne scar depth. Timepoint: At baseline and after 3 months. Method of measurement: Skin ultrasonography. Total acne scar severity. Timepoint: At the base of study and after 3 months. Method of measurement: Photographic image analysis by dermatologist. Acne severity based on self-assessment scoring. Timepoint: At the base of study and then after 3 months. Method of measurement: Visual analogue scale. IBSA Farmaceutici Tehran University of Medical Sciences Paeezan Tejarat Mehr Approved 2019-07-07 National Committee for Ethics in Biomedical Research Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town Tehran Tehran Iran (Islamic Republic of)