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IRCT20140212016557N10 IRCT 2022-01-22 Shiraz University of Medical Sciences Effect of nanofat injection in the treatment of stretch marks Comparison of the effect of nanofat graft with microneedling in the clinical improvement of striae distensae 2022-01-10 anticipated 20 Complete https://irct.ir/trial/60944 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The participants were randomized using permuted block randomization (size of each block: 4), in individual units, using random allocation software. The output of software is a table that determines the right or left side undergoes nanofat grafting, Blinding description: Due to the different treatment methods in two sides, the participants cannot be blinded. Principle investigator, and care provider physician are also aware of the the side undergoing nanofat grafting. But, outcome assessors are not aware of the side undergoing nanofat grafting in each patient. 3 Striae distensae. Intervention 1: Intervention group: Nanofat grafting in the striae of one side of the body (one session at the beginning of study). Intervention 2: Control group: microneedling in striae of one side of the body (3 session monthly). 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 Possibility of loss of confidentiality
public Mozhdeh Sepaskhah
Shiraz University of Medical Sciences, Zand St, Shiraz, Iran
Shiraz Iran (Islamic Republic of) 7134814336 +98 71 3212 5239 sepaskhah@sums.ac.ir Shiraz University of Medical Sciences scientific Mozhdeh Sepaskhah
Shiraz University of Medical Sciences, Zand St, Shiraz, Iran
Shiraz Iran (Islamic Republic of) 7134844119 +98 71 3212 5239 sepaskhah@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) patients of 18 to 60 years of age bilateral striae distensae (alba and rubra) site on the abdomen, buttock, calves, thighs, and arms 18 years 60 years Both pregnancy lactation body mass index less than or equal to 22 history of nickel hypersensitivity history of treatment for striae in the recent one year history of hypertrophic scar or keloid formation active infections on the study area severe underlying internal diseases history of hypercoagulation states Consumption of immunosuppressant drugs, systemic retinoids, corticosteroids, and anabolic steroids in the recent 2 months history of allergy to any ingredient of tumescent anesthetic solution history of abdominoplasty scar on the fat donor site history of Cushing syndrome history of polycystic ovary syndrome body dysmorphic disorder L90.6 Striae atrophicae Treatment - Surgery Treatment - Surgery Intervention group: Nanofat grafting in the striae of one side of the body (one session at the beginning of study) Control group: microneedling in striae of one side of the body (3 session monthly) Clinical improvement of striae. Timepoint: The patients will be assessed in 3 monthly visits for microneedling, and 6 months after the first visit. Method of measurement: Global aesthetic improvement scale, measured as: Grade 0: Worsening of lesions; Grade 1: No change (< 25% improvement); Grade 2: Improved (25-50% improvement); Grade 3: Much improved (51-75% improvement); Grade 4: Very much improved (76-100% improvement). Striae size reduction. Timepoint: 3 monthly visits for microneedling, and 6 months after the first visit. Method of measurement: Percentage of striae width reduction. Striae color. Timepoint: At the beginning of treatment, 3 monthly visits for microneedling, and 6 months after the first visit. Method of measurement: Pigment index is measured by colorimetric device. Dermoscopic features of striae. Timepoint: At the beginning of treatment, 3 monthly visits for microneedling, and 6 months after the first visit. Method of measurement: Dermatoscopic features like color, vascularity, width, and texture of striae. Patient satisfaction. Timepoint: At the end of treatment. Method of measurement: َA 5-point scale. 4: Extremely satisfied, 3:Very satisfied, 2: satisfied, 1: Slightly satisfied, 0: Not satisfied. Pain during treatment. Timepoint: At the 3 sessions of monthly treatment. Method of measurement: Pain illustrated numerical rating scale. Shiraz University of Medical Sciences Approved 2021-12-20 Ethics committee of Shiraz University of Medical Sciences Shiraz University of Medical Sciences, Zand St., Shiraz. Iran Shiraz Fars Iran (Islamic Republic of)