Evaluation of durability of fat injection with Hyaluronic acid gel (Profhilo)

Phase 2

Recruiting

Conditions: autologous fat transplant with and without Profhilo hyaluronic acid gel.
Encounter for cosmetic surgery
Z41.1

Registration Number: IRCT20210519051343N1

Lead Sponsor: Tehran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 10

Inclusion Criteria

age between 18 and 70 years old
score of Wrinkle Severity Rating Scale between 2-4
patients who don't want to do surgical procedures
signing an inform consent

Exclusion Criteria

Candidate for cosmetic facial surgery
pregnancy and lactation
neuromuscular disease
uncontrolled systemic disease
infection, scar, or abnormality at the site of injection
a history of filler or fat injection in the past 12 months
patients under treatment with immunosuppressive drugs, aspirin, narcotics, antidepressants, and corticosteroids
history of adverse reactions to hyaluronic acid gel and other gels
history of adverse reaction to tumescent solution
adverse reactions to injection instruments( needle and cannula)
facial asymmetry

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Specialist's score based on GAIS-doctor score. Timepoint: baseline-1 month after -6 months after. Method of measurement: Measurement based on the score given by the non-executive physician based on GAIS-doctor score which includes 7 scores:1- very much improved.2-: much improved.3-: improved.4-: no change.5-worse.6- much worse.7- very much worse.

Secondary Outcome Measures

Name	Time	Method
Wrinkle severity. Timepoint: baseline-1 month after- 6 months after. Method of measurement: measurement is done according to the Wrinkle Severity Rating Scale (WSRS) scoring system which includes 5 scores:0- Absent.1- Slight wrinkles.2-Quite evident wrinkles.3-Evident wrinkles.4-Marked wrinkles.5-Very marked wrinkles.