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EFFICACY OF INJECTABLE POLY-D, L-LACTIC ACID (PDLLA) IN DORSAL HAND VOLUMIZATION IN THAI SUBJECT WITH 8 ML DILUTION VERSUS 10 ML DILUTION(3 MONTHS EVALUATION)

EFFICACY OF INJECTABLE POLY-D, L-LACTIC ACID (PDLLA) IN DORSAL HAND VOLUMIZATION IN THAI SUBJECT WITH 8 ML DILUTION VERSUS 10 ML DILUTION(3 MONTHS EVALUATION)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250519001
Enrollment
10
Registered
2025-05-19
Start date
2025-07-01
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

Thai patients who has Busso Hand Volume Severity Scale score of 2 to 4 Dorsal hand volume, PDLLA

Interventions

Mix 1 vial of PDLLA with 7 mL of sterile water with 1 mL of lidocaine, totaling 8 mL. The injections will be administered at predetermined sites by a qualified physician using a 23G blunt cannula. Two
Active Comparator Procedure/Surgery,Active Comparator Procedure/Surgery
Dorsal hand injection by 8 ml dilution of PDLLA,Dorsal hand injection by 10 ml dilution of PDLLA

Sponsors

K.N.A INTER PHARMA Co.,Ltd
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Thai adult, aged 40-60 years, any gender 2. Busso Hand Volume Severity Scale score of 2 to 4 3. Willingness to participate in the study

Exclusion criteria

Exclusion criteria: (1) History of allergy to Poly-D,L-lactic acid (PDLLA) or local anesthetics (2) Received aesthetic procedures on the back of the hands within the past 6 months (3) Presence of underlying diseases such as diabetes, thyroid disorders, or cancer (4) Skin diseases on the back of the hands (5) History of keloids or hypertrophic scars (6) Use of corticosteroids during the study period (7) Taking collagen-stimulating dietary supplements (8) Pregnant or breastfeeding women (9) Individuals with unrealistic expectations regarding treatment outcomes (10) Unable to attend follow-up visits for the study

Design outcomes

Primary

MeasureTime frame
Dorsal hand volume At 3 months after intervention Busso Hand Volume Severity Scale score ,Dorsal hand volume At 3 months after intervention Antera 3D

Countries

Thailand

Contacts

Public ContactPrompetch Rodsawatchuchoke

Dhurakij Pundit University

supremepp1007@gmail.com663916415

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026