Skin Aging, Wrinkles
Conditions
Keywords
Poly-L-Lactic acid, PLLA, Neck rejuvenation, Skin laxity
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.
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
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.
Sponsors
Institute of Dermatology, Thailand
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Neck Skin Laxity Scale (NSL scale) Score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in skin Firmness and Elasticity Assessed by Cutometer® Dual MPA 580 | 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. |
| Incidence of Treatment-Related Adverse Events | 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. |
| 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 | 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. |
Countries
Thailand
Outcome results
None listed