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

A comparative study of the durability of fat injection alone with respect to fat injection along with the injection of Hyaluronic Acid gel(Profhilo) in the cheeks of patients referred to Razi Hospital in the years 1399-1400

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20210519051343N1
Enrollment
10
Registered
2021-11-24
Start date
2021-11-21
Completion date
Unknown
Last updated
2021-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

autologous fat transplant with and without Profhilo hyaluronic acid gel. Encounter for cosmetic surgery

Interventions

Intervention 1: Intervention group: The group that undergoes hyaluronic acid gel injection after fat injection - selected fat donor sites of the outer thigh. Aspiration is done with a cannula to colle

Sponsors

Tehran University of Medical Sciences
Lead Sponsor
IBSA pharmeceutics
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAmir Houshang Ehsani

Tehran University of Medical Sciences

ehsanih@sina.tums.ac.ir+98 21 5563 0223

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026