Skin AgingNCT07689344
Poly-L-lactic Acid (PLLA) Injection for Neck Skin Laxity: A Pilot Study
A study testing Poly-L-Lactic Acid (Sculptra) injection in people with Skin Aging and Wrinkles, run by Institute of Dermatology, Thailand at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Aging, Wrinkles
- What is being tested?
- Poly-L-Lactic Acid (Sculptra) injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jul 2026to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site
Institute of Dermatology
Ratchathewi, Bangkok, 10400
Medical Sciences (Dermatology), +6623545222, dr_tanongkiet@yahoo.com
Tanongkiet Tienthavon, +66952072833
About this study
Official title: The Efficienctiveness of Poly-L-Lactic Acid, PLLA for the Treatment of Skin Laxity of the Neck: A Pilot Study
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.
Read the 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.
- Conditions
- Skin Aging, Wrinkles
- Being tested
- Poly-L-Lactic Acid (Sculptra) injection
- Keywords
- Poly-L-Lactic acid, PLLA, Neck rejuvenation, Skin laxity
- Medical subject headings
- Cutis Laxa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Poly-L-Lactic Acid (Sculptra) injectionDrug
Also called PLLA, Sculptra
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Poly-L-Lactic Acid (Sculptra) injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- = Mild : Minimal skin laxity with slight loss of firmness and subtle horizontal lines.
- = Moderate : Noticeable skin laxity with visible horizontal lines and mild skin redundancy.
- = Advanced : Marked skin laxity with prominent folds, visible skin redundancy, and moderate loss of neck contour.
- = 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.
Measured: 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
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 :
- = Very dissatisfied
- = Dissatisfied
- = Neutral
- = Satisfied
- = Very satisfied Higher scores indicate greater participant satisfaction with neck appearance following treatment.
Measured: 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.
Measured: Baseline (Week 0), Week 8, Week 16, and Week 24
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.
Measured: Immediately after PLLA injection (Week 0), Week 8, Week 16, and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Skin AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Dermatology, Thailand
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07689344
- Sponsor's protocol ID
- 006/2568
- Status last verified
- Jul 2026
- First submitted
- 9 Jun 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 35761856Tateo 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.
PubMed 33854352Nikolis 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.
PubMed 34140793Mazzuco 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.
PubMed 19438668
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficienctiveness of Poly-L-Lactic Acid, PLLA for the Treatment of Skin Laxity of the Neck: A Pilot Study
- ClinicalTrials.gov ID
- NCT07689344
- Acronym / sponsor ID
- 006/2568
- Conditions
- Skin Aging, Wrinkles
- Keywords
- Poly-L-Lactic acid, PLLA, Neck rejuvenation, Skin laxity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Institute of Dermatology, ThailandOther government
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 8 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| PLLA Injection | Experimental | Drug: Poly-L-Lactic Acid (Sculptra) injectionParticipants 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. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Poly-L-Lactic Acid (Sculptra) injectionAlso: PLLA, SculptraPoly-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. | Drug | PLLA Injection |
Primary outcome
Change in Neck Skin Laxity Scale (NSL scale) Score
Time frame: 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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Background: PubMed 35761856Christen 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.
- Background: PubMed 33854352Tateo 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.
- Background: PubMed 34140793Nikolis 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.
- Background: PubMed 19438668Mazzuco 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.
- Standardizing Dimensionless Cutometer Parameters to Determine In Vivo Elasticity of Human SkinLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Poly-L-Lactic Acid (Sculptra) injection in people with Skin Aging and Wrinkles, run by Institute of Dermatology, Thailand at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Neck Skin Laxity Scale (NSL scale) Score (time frame: Baseline (Week 0), Week 8, Week 16, and Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07689344, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.