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Poly-L-lactic Acid (PLLA) Injection for Neck Skin Laxity: A Pilot Study

7. juli 2026 opdateret af: Institute of Dermatology, Thailand

The Efficienctiveness of Poly-L-Lactic Acid, PLLA for the Treatment of Skin Laxity of the Neck: A Pilot Study

Skin aging of the neck commonly leads to wrinkles and skin laxity due to the gradual loss of collagen and structural support in the skin. Although several treatments are available, effective non-surgical options for improving neck skin laxity remain limited. This pilot study aims to evaluate the effectiveness and safety of Poly-L-Lactic acid (PLLA) injections for improving neck skin laxity.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This study is a prospective pilot interventional study designed to evaluate the effectiveness and safety of Poly-L-Lactic acid (PLLA) injections for the treatment of neck skin laxity. Eligible Thai male and female participants aged 30 to 60 years with neck skin laxity grades 1 to 4 according to the Neck Skin Laxity Scale (NSL scale) will be enrolled. Participants will receive a single treatment session of PLLA injection to the neck using a cannula technique in the subcutaneous plane with a linear retrograde fanning method through lateral entry points. Approximately 8 mL of PLLA solution will be injected on each side of the neck, for a total volume of 16 mL per participant. Clinical outcomes will be evaluated at baseline and during follow-up visits at weeks 8, 16, and 24. Outcome measures include improvement in neck skin laxity assessed using the NSL scale, changes in skin elasticity measured by using the Cutometer® Dual MPA 580, participant satisfaction, and treatment-related adverse events. Outcome assessment will be performed by comparing follow-up measurements with baseline values.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

10

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Thailand
    • Bangkok
      • Ratchathewi, Bangkok, Thailand, 10400
        • Institute of Dermatology
        • Kontakt:
        • Kontakt:
          • Tanongkiet Tienthavon
          • Telefonnummer: +66952072833

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Inclusion Criteria:

  • Thai male or female participants aged 30-60 years
  • Individuals who wish to improve neck skin laxity
  • Presence of neck skin laxity grade 1-4 according to the Neck Skin Laxity Scale (NSL scale)

Exclusion Criteria:

  • Pregnant or breastfeeding women
  • History of allergy or hypersensitivity to local anesthetics or components of collagen-stimulating substances
  • Active autoimmune disease requiring systemic treatment
  • History of cosmetic procedures in the neck area, including laser treatment, radiofrequency, or ultrasound-based devices within 6 months prior to treatment
  • History of dermal filler injection in the neck area
  • History of botulinum toxin injection in the neck area within 6 months prior to treatment

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: PLLA Injection
Participants will receive a single treatment session of Poly-L-Lactic acid (PLLA) injection for the treatment of neck skin laxity. PLLA will be administered to the neck using a cannula technique in the subcutaneous plane. Approximately 16 mL of PLLA solution will be injected per participants. Clinical outcomes will be evaluated at baseline and during follow-up visits at Weeks 8, 16, and 24.
Medicin: Poly-L-Lactic Acid (Sculptra) injection
Poly-L-Lactic acid (PLLA) is used as a collagen-stimulating injectable for the treatment of neck skin laxity. The PLLA solution is prepared by reconstituting PLLA with sterile water and lidocaine to a total volume of 16 mL. Participants will receive a single treatment session of PLLA injection to the neck using a cannula technique. The injection is performed in the subcutaneous plane using a linear retrograde fanning technique through lateral entry points of the neck. Approximately 8 mL of PLLA solution will be injected on each side of the neck (total 16 mL per participant). Clinical outcomes will be assessed at weeks 8, 16, and 24.
Andre navne:
  • Sculptra
  • PLLA

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Neck Skin Laxity Scale (NSL scale) Score
Tidsramme: Baseline (Week 0), Week 8, Week 16, and Week 24

Neck skin laxity will be evaluated using standardized clinical photographs captured with the VECTRA® image system. Blinded dermatologists will assess neck skin laxity using NSL Scale at baseline (Week0), Week 8, Week 16, and Week 24. The NSL Scale is a 5-point ordinal scale ranging from 0 to 4, where :

0 = Absent : No visible neck skin laxity.

  1. = Mild : Minimal skin laxity with slight loss of firmness and subtle horizontal lines.
  2. = Moderate : Noticeable skin laxity with visible horizontal lines and mild skin redundancy.
  3. = Advanced : Marked skin laxity with prominent folds, visible skin redundancy, and moderate loss of neck contour.
  4. = Severe : Severe skin laxity characterized by extensive redundant skin, deep folds, wrinkles, and substantial loss of neck contour.

Higher scores indicate greater neck skin laxity and a worse aesthetic appearance, while lower scores indicate less neck skin laxity and improvement in neck appearance.
Baseline (Week 0), Week 8, Week 16, and Week 24

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Participant-Reported Neck Appearance Satisfaction Score Assessed Using the 5-Point Neck Appearance Satisfaction Scale
Tidsramme: Baseline (Week 0), Week 8, Week 16, and Week 24

Participant-reported satisfaction with neck appearance following PLLA treatment will be assessed at baseline (Week 0), Week 8, Week 16 and Week 24 using a 5-point Neck Appearance Satisfaction Scale. The scale ranges from 1 to 5, where :

  1. = Very dissatisfied
  2. = Dissatisfied
  3. = Neutral
  4. = Satisfied
  5. = Very satisfied Higher scores indicate greater participant satisfaction with neck appearance following treatment.
Baseline (Week 0), Week 8, Week 16, and Week 24
Change in skin Firmness and Elasticity Assessed by Cutometer® Dual MPA 580
Tidsramme: Baseline (Week 0), Week 8, Week 16, and Week 24
Skin firmness and elasticity will be assessed using the Cutometer® Dual MPA 580 at baseline (Week 0), Week 8, Week 16, and Week 24. The Cutometer® Dual MPA 580 is a non-invasive device used to evaluate the biomechanical properties of the skin, including skin firmness and elasticity. Changes in skin biomechanical properties from baseline to Week 24 will be evaluated.
Baseline (Week 0), Week 8, Week 16, and Week 24
Incidence of Treatment-Related Adverse Events
Tidsramme: Immediately after PLLA injection (Week 0), Week 8, Week 16, and Week 24
Treatment-related adverse events will be assessed immediately after PLLA injection (Week 0) and at Week 8, Week 16, and Week 24 through participant interviews and clinical examinations. Adverse events including pain, swelling ( edema), bruising (ecchymosis), palpable nodules, granuloma formation, infection, hypersensitivity reactions, and any other treatment-related adverse events will be recorded. Pain will be managed with analgesics as clinically indicated. Early swelling and bruising will be managed with cold compresses, while delayed nodules due to product accumulation may be treated with massage and normal saline injection. Persistent nodules suspected to be granulomas may undergo biopsy for confirmation, followed by intralesional triamcinolone injection if clinically indicated. The outcome measure will be the number and proportion of participants experiencing treatment-related adverse events.
Immediately after PLLA injection (Week 0), Week 8, Week 16, and Week 24

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Institute of Dermatology, Thailand

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

1. august 2026

Studieafslutning (Anslået)

1. september 2026

Datoer for studieregistrering

Først indsendt

9. juni 2026

Først indsendt, der opfyldte QC-kriterier

7. juli 2026

Først opslået (Faktiske)

8. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 006/2568

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Hudældning

Kliniske forsøg med Poly-L-Lactic Acid (Sculptra) injection

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Betingelser

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Placeringer

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