Poly-L-lactic Acid (PLLA) Injection for Neck Skin Laxity: A Pilot Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Poly-L-Lactic Acid (Sculptra) injection.
- Who it may be relevant to
- Registry conditions: Skin Aging, Wrinkles. Basic parameters: 30 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Thailand
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Efficienctiveness of Poly-L-Lactic Acid, PLLA for the Treatment of Skin Laxity of the Neck: A Pilot Study
Overview
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.
Detailed description
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.
Interventions
- Drug 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
Primary outcome measures
- Change in Neck Skin Laxity Scale (NSL scale) Score [Time frame: Baseline (Week 0), Week 8, Week 16, and Week 24]
Secondary outcome measures (3)
- Participant-Reported Neck Appearance Satisfaction Score Assessed Using the 5-Point Neck Appearance Satisfaction Scale [Time frame: Baseline (Week 0), Week 8, Week 16, and Week 24]
- Change in skin Firmness and Elasticity Assessed by Cutometer® Dual MPA 580 [Time frame: Baseline (Week 0), Week 8, Week 16, and Week 24]
- Incidence of Treatment-Related Adverse Events [Time frame: Immediately after PLLA injection (Week 0), Week 8, Week 16, and Week 24]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Thailand · 1 center
- Institute of Dermatology — Ratchathewi
Publications
- 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
- 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
- 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
- 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
Identifiers
NCT: NCT07689344 · 006/2568