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

NCT07689344 | Not Yet Recruiting

• 1 other identifier: 006/2568
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Skin Aging; Wrinkles

Keywords

Poly-L-Lactic acid; PLLA; Neck rejuvenation; Skin laxity

Outcome Measures

Primary Outcomes (1)

• Change in Neck Skin Laxity Scale (NSL scale) Score

  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

Secondary Outcomes (3)

• Participant-Reported Neck Appearance Satisfaction Score Assessed Using the 5-Point Neck Appearance Satisfaction Scale

  Baseline (Week 0), Week 8, Week 16, and Week 24

• Change in skin Firmness and Elasticity Assessed by Cutometer® Dual MPA 580

  Baseline (Week 0), Week 8, Week 16, and Week 24

• Incidence of Treatment-Related Adverse Events

  Immediately after PLLA injection (Week 0), Week 8, Week 16, and Week 24

Study Arms (1)

PLLA Injection

EXPERIMENTAL

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.

Drug: Poly-L-Lactic Acid (Sculptra) injection

Interventions

Poly-L-Lactic Acid (Sculptra) injection DRUG

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.

Also known as: PLLA, Sculptra

PLLA Injection

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Dermatology, Thailand: lead

Study Sites (1)

Institute of Dermatology

Ratchathewi, Bangkok, 10400, Thailand

Location

Related Publications (4)

• Christen MO. Collagen Stimulators in Body Applications: A Review Focused on Poly-L-Lactic Acid (PLLA). Clin Cosmet Investig Dermatol. 2022 Jun 21;15:997-1019. doi: 10.2147/CCID.S359813. eCollection 2022.

  PMID: 35761856 BACKGROUND

• Tateo A, Siquier-Dameto G, Artzi O, Humzah D, Molina B, Jain R, Lanzarotti A, Laouedj M, Dapis N, Bellia G. Development and Validation of IBSA Photographic Scale for the Assessment of Neck Laxity. Clin Cosmet Investig Dermatol. 2021 Apr 7;14:349-354. doi: 10.2147/CCID.S302860. eCollection 2021.

  PMID: 33854352 BACKGROUND

• Nikolis A, Avelar LE, Enright KM. Evaluation of Cannula Safety in Injection of Poly-L-Lactic Acid. Clin Cosmet Investig Dermatol. 2021 Jun 10;14:615-622. doi: 10.2147/CCID.S305479. eCollection 2021.

  PMID: 34140793 BACKGROUND

• Mazzuco R, Hexsel D. Poly-L-lactic acid for neck and chest rejuvenation. Dermatol Surg. 2009 Aug;35(8):1228-37. doi: 10.1111/j.1524-4725.2009.01217.x. Epub 2009 May 12.

  PMID: 19438668 BACKGROUND

Related Links

• Standardizing Dimensionless Cutometer Parameters to Determine In Vivo Elasticity of Human Skin

MeSH Terms

Conditions

Cutis Laxa

Interventions

poly(lactide); New-Fill; Injections

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: This study is a prospective pilot interventional study evaluating the effectiveness of PLLA injections for the treatment of neck skin laxity. All participants will receive a single treatment session of PLLA injections to the neck, and clinical outcomes will be assessed at Weeks 8, 16, and 24.

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: July 8, 2026
• Study Start: July 1, 2026
• Primary Completion: August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 8, 2026

Record last verified: 2026-07

Locations

TH (1)