Poly-L-lactic Acid (PLLA) Injection for Neck Skin Laxity: A Pilot Study
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-60
SponsorInstitute of Dermatology, Thailand
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Poly-L-Lactic Acid (Sculptra) injection
DrugPoly-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.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: PLLA InjectionExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Baseline (Week 0), Week 8, Week 16, and Week 24Secondary outcomes
1
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 242
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 243
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 24Sponsors and contacts
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Source ClinicalTrials.gov
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