The efficacy and safety of Poly-d, l-lactic Acid (PDLLA) injection for dorsal hand skin rejuvenation in 3 months

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

TCTR

Registry ID

TCTR20250612001

Enrollment

Registered

2025-06-12

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

Age-related skin aging on the dorsum of the hands in healthy individuals aged 40 to 60 and are not associated with underlying disease Skin Aging Skin Wrinkling dermal filler PLLA polymer poly(D,L-lactide)

Interventions

Participants receive a single intradermal injection of poly-D,L-lactic acid (PDLLA) reconstituted with 7 mL of sterile water and 1 mL of 2% lidocaine (total volume: 8 mL). The entire vial (200 mg) is

Experimental Device,Experimental Device

Poly-D,L-lactic acid,Poly-D,L-lactic acid

Eligibility

Sex/Gender

All

Age

40 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Thai nationality 2. Age between 40 and 60 years, Any gender 3. Interested in rejuvenating the skin on the back of the hands 4. Willing to participate and able to provide informed consent

Exclusion criteria

Exclusion criteria: 1. Known allergy to poly-D,L-lactic acid (PDLLA) used in the treatment 2. History of undergoing any aesthetic procedures (injectable, device-based, or surgical) on the dorsum of the hands within the past 6 months 3. Active skin infection at or near the injection site 4. Presence of systemic disorders, including genetic disorders affecting collagen production or bleeding disorders 5. Immunocompromised status, current use of immunosuppressive drugs, or current cancer diagnosis 6. History of keloid or hypertrophic scarring 7. Use of topical retinoids or skin exfoliating agents on the hands during the study period 8. Pregnant or breastfeeding women

Design outcomes

Primary

Measure	Time frame
skin elasticity of dorsal hand at 12 months after end of the intervention Cutometer Dual MPA580 with Cutometer probe,skin texture, pigmentation and wrinkles of dorsal hand at 12 months after end of the intervention ANTERA 3D imaging system	—

Secondary

Measure	Time frame
Severity of injection site pain 30 minutes post injection Visual Analog Scale (VAS),Occurrence of post-injection complications at multiple follow-up visits (24h, 48h, 72h, 2w, 4w, 8w, 12w) complication assessment form	—

Countries

Thailand

Contacts

Public ContactKanta Tantichusak

College of Integrative Medicine, Dhurakij pundit university

kantatrial@gmail.com029547300

Outcome results

None listed

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