Effect of nanofat injection in the treatment of stretch marks

Phase 3

Recruiting

• Conditions: Striae distensae.; Striae atrophicae; L90.6

• Registration Number: IRCT20140212016557N10
• Lead Sponsor: Shiraz University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 7 February 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

patients of 18 to 60 years of age
bilateral striae distensae (alba and rubra)
site on the abdomen, buttock, calves, thighs, and arms

Exclusion Criteria

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).

Secondary Outcome Measures

Name	Time	Method
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.