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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20220217002
Enrollment
60
Registered
2022-02-17
Start date
2014-12-15
Completion date
Unknown
Last updated
2026-08-03

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

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

Interventions

Each patient from the autologous fibroblast group had their tissue collected at the post-auricular area. Preoperatively, 2 percent lidocaine was injected and a 3-mm punch biopsy was performed. The don
Q-Med, Uppsala, Sweden) on both NLFs (0.5 ml each side).
Experimental Procedure/Surgery,Active Comparator Procedure/Surgery
Autologous fibroblast,Hyaluronic acid filler

Sponsors

Research department, Faculty of Medicine Siriraj Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
clinical improvement 1-, 3-, 6-, and 12-months follow-up increation of facial volume captured by Vectra H1 Imaging System

Secondary

MeasureTime frame
safety 1-, 3-, 6-, and 12-months follow-up history taking and physical examination

Countries

Thailand

Contacts

Public ContactRungsima Wanitphakdeedecha

Faculty of Medicine Siriraj Hospital, Mahidol University

rungsima.wan@mahidol.ac.th0816406300

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026