]>
IRCT20220924056033N1 IRCT 2022-10-07 Shiraz University of Medical Sciences Effect of microneedling and topical basic fibroblast growth factor in treatment of stretch marks Comparison of the effect of combination microneedling and topical basic fibroblast growth factor with microneedling alone in the improvement of stria distensae 2022-10-23 anticipated 30 Complete https://irct.ir/trial/66133 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The study groups are divided into two groups A and B using random allocation software using the permutation block method. Group A is assigned to microneedling and local fibroblast growth factor intervention group, and group B is assigned to microneedling intervention alone. Considering that patients enter the plan from number 1 to 30 in order; The colleague entered the study patients in the order of referral in the relevant intervention group and this order is maintained until the end of the study. Dark colored envelopes are used to hide the order of randomization codes, Blinding description: In this plan, the patients are aware of the type of intervention because patients in one group (group A) receive an invasive intervention (microneedling) along with a drug (local fibroblast growth factor) that cannot be used as a placebo, and the other group (group A) B) receives only microneedling. However, the clinical assessment is not aware of the type of study and only recognizes patients with labels A and B, and the design is assessor blind in this regard. 3 Stria distensa. Intervention 1: Intervention group: Combination of microneedling and Basic Fibroblas Growth Factor (BFGF) in the treatment of stria distensae (each month three sessions). Intervention 2: Control group: Use of microneedling alone in the treatment of stria distensae (each month three sessions). No - There is not a plan to make this available Justification or reason for not sharing IPD is There is not information any more
public Rahil Hamedpour
Zand street, Shahid Faghihi hospital
Shiraz Iran (Islamic Republic of) 7173776773 +98 71 3234 4997 anisa1370@gmail.com Shiraz University of Medical Sciences scientific Rahil Hamedpour
Zand street, Shahid Faghihi hospital
Shiraz Iran (Islamic Republic of) 7173776773 +98 71 3234 4997 anisa1370@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Patents between 18 and 60 years old 18 years 60 years Both Pregnant women Lactating women Diabetic Hypertension Hypothyroidism Hyperthyroidism Immunosuppressed patients Patients who recieved stria treatment 3 months ago or have infection on the stria L90.6 Striae atrophicae Treatment - Surgery Treatment - Surgery Intervention group: Combination of microneedling and Basic Fibroblas Growth Factor (BFGF) in the treatment of stria distensae (each month three sessions) Control group: Use of microneedling alone in the treatment of stria distensae (each month three sessions) Clinical improvement stria. Timepoint: Patients will be visited 4 times, 0, 1, 2, 5 month. Method of measurement: The GAIS(Global Aesthetic Improvement Scale) is measured as follows:Grade 0: worsening of lesions Grade1: 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). Stria size reduction. Timepoint: Patients will be visited 4 times, 0, 1, 2, 5 month. Method of measurement: Rate of width reduction (%)=Baseline width-Follow upwidth/Baseline width ×100. Stria color. Timepoint: Patients will be visited 4 times, 0, 1, 2, 5 month. Method of measurement: Melanin index is measured bySkinColorCatch colorimeter(Delphin, Finland) and is presentedas average of .3 points measure. Patient satisfaction. Timepoint: Patients will be visited 4 times, 0, 1, 2, 5 month. Method of measurement: Patient satisfaction is assessed by a 5point scale: 4: Extremely satisfied3: Very satisfied 2: satisfied 1:Slightly satisfied 0: Not satisfied. Shiraz University of Medical Sciences Approved 2022-09-11 Ethics committee of Shiraz University of Medical Sciences Zand street, Shahid Faghihi hospital Shiraz Fars Iran (Islamic Republic of)