MedPath

The Comparison of Autologous Cultured Fibroblast and Hyaluronic Acid Filler in the Treatment of Nasolabial folds: A Pilot Study

Phase 4
Completed
Conditions
patients who expressed dissatisfaction with their nasolabial folds based on a score of -1 or -2 on the Subject Wrinkle Assessment Scale
Nasolabial fold
Registration Number
TCTR20220217002
Lead Sponsor
Research department, Faculty of Medicine Siriraj Hospital
Brief Summary

Autologous fibroblast injection is a safe and effective treatment for NLFs. Unlike conventional fillers, the autologous cultured fibroblast cells are injected more superficially and may require a longer period to show improvement. It also offers the promise of sustained growth of living cells, which may lead to greater persistence than other fillers.

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
55
Inclusion Criteria

patients who expressed dissatisfaction with their nasolabial folds based on a score of -1 or -2 on the Subject Wrinkle Assessment Scale

Exclusion Criteria

(1) were pregnant or lactating; (2) had a history of connective tissue disorder, skin cancers, or related diseases; (3) had previous autologous fibroblast treatment; (4) had previous treatment with fillers, lasers or energy-based devices within the last 12 months; (5) had previous treatment using transdermal drug delivery, chemical peeling or topical retinoid within the last month; or (6) had allergy to collagen, meat and dairy products, gentamycin, amphotericin B, or related products.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
clinical improvement 1-, 3-, 6-, and 12-months follow-up increation of facial volume captured by Vectra H1 Imaging System
Secondary Outcome Measures
NameTimeMethod
safety 1-, 3-, 6-, and 12-months follow-up history taking and physical examination
© Copyright 2025. All Rights Reserved by MedPath