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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
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.
Institute of Dermatology
Ratchathewi, Bangkok, Thailand
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.
Time frame: Baseline (Week 0), Week 8, Week 16, and Week 24
Participant-Reported Neck Appearance Satisfaction Score Assessed Using the 5-Point Neck Appearance Satisfaction Scale
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.
Time frame: Baseline (Week 0), Week 8, Week 16, and Week 24
Change in skin Firmness and Elasticity Assessed by Cutometer® Dual MPA 580
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.
Time frame: Baseline (Week 0), Week 8, Week 16, and Week 24
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Incidence of Treatment-Related Adverse Events
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.
Time frame: Immediately after PLLA injection (Week 0), Week 8, Week 16, and Week 24