Skin LaxityNCT06948045
RESTRUCTURING THE MANDIBULAR ANGLE IN FACIAL AGING: A NOVEL TECNIQUE USING POLY-L-LACTIC ACID
A study testing PLLA application to the mandibular angle in people with Skin Laxity and Facial Aging, run by Doris Hexsel.
Trial summary
Skin laxity is a common complaint among patients seeking aesthetic dermatological interventions, affecting the facial contour, especially in the mandibular angle, due to bone aging and the loss of tissue support in the lower third of the face. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Laxity, Facial Aging
- What is being tested?
- PLLA application to the mandibular angle
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to Feb 2027
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female individuals aged between 18 and 65 years of age.
- Immunocompetent individuals.
- Medical history and physical examination that, in the opinion of the investigator, do not prevent or contraindicate participation in the study or the use of the investigational product.
- Female research participants of childbearing potential with a negative UPT at baseline (Day 1). These participants must use a highly effective contraceptive method throughout the study: combined oral contraceptives (estrogen and progesterone) or implanted/injectable contraceptives (with a stable dose for at least 1 month prior to study entry), bilateral tubal ligation, hormonal intrauterine device (inserted at least 1 month before entering the study), strict abstinence (at least 1 month prior to study entry and agreeing to continue throughout the study duration), vasectomized partner (at least 3 months before study entry), or condom use.
- Women not of childbearing potential (e.g. postmenopausal with no menstrual bleeding for 1 year prior to study entry, hysterectomy, or bilateral oophorectomy).
- Research participants who are willing and able to comply with the duration and procedures required by the study protocol.
- Research participants who understand and sign the ICF and the ICF for image use authorization upon entering the study, before any investigational procedures are performed.
Who cannot join
- Participants unable to understand the research protocol and/or follow the study schedule.
- Pregnant or breastfeeding women, or those planning to become pregnant during the study period.
- History of treatment in the past 6 months or planning to undergo procedures with lasers, intense pulsed light, radiofrequency, microfocused ultrasound, or deep chemical peels.
- History of treatment with botulinum toxin on the face in the past 6 months or planning to undergo this procedure.
- History of treatment with hyaluronic acid-based or other non-permanent dermal fillers on the face in the past 12 months, or planning to undergo this procedure.
- History of treatment with collagen biostimulators on the face, such as poly-L-lactic acid (PLLA), calcium hydroxyapatite, or polycaprolactone, in the past 36 months, or planning to undergo this procedure.
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- History of treatment with or planning to use permanent fillers on the face.
- Current use, use within the past 3 months, or planned use of collagen-based supplements.
- Any surgical procedure or other treatment previously performed that has affected the area to be assessed in this study.
- Active inflammation or infections in the facial region.
- Severe psychiatric disorders.
- Any other uncontrolled, chronic, or severe medical condition that, in the investigator's opinion, may interfere with the interpretation of the clinical study results or pose significant risk to the research participant.
- History of sensitivity to any component of the product used in the study.
- Vulnerable participants (such as those deprived of liberty), as defined in Section 1.61 of the International Conference on Harmonization (ICH) Guideline for Good Clinical Practice (GCP).
- History of poor treatment adherence or demonstrated lack of cooperation in adhering to the study protocol.
- Current participation in any other drug or device clinical study OR participation within 30 days prior to Day 1 or within an exclusion period of a previous clinical study.
About this study
Official title: Restructuring the Mandibular Angle in Facial Aging: a Novel Tecnique Using Poly-L-Lactic Acid
Skin laxity is a common complaint among patients seeking aesthetic dermatological interventions, affecting the facial contour, especially in the mandibular angle, due to bone aging and the loss of tissue support in the lower third of the face. Facelift surgery is an effective method to address this issue, but it is invasive and may impact the definition of the jawline. As an alternative, poly-L-lactic acid (PLLA) stimulates collagen production, improving facial contour in a minimally invasive manner. This study aims to evaluate the safety and effectiveness of a new, low-cost, and quick application technique using poly-L-lactic acid in the mandibular angle and anterior to the mandibular ligament. The proposed technique seeks to enhance facial contour, provide an additional lifting effect, and contribute to overall facial rejuvenation. This is a clinical, prospective, and interventional study, allowing the analysis of clinical outcomes in terms of efficacy and safety. Twenty volunteers aged between 18 and 65, of both genders, with no restrictions on the use of collagen bio-stimulators, will be recruited. After confirming inclusion and exclusion criteria, participants will sign the Informed Consent Form (ICF) and be eligible for the study. The first intervention will occur at visit 2 (day 1), the second intervention at visit 3 (day 30 ± 15), and the third intervention will be performed as indicated at visit 4 (day 60 ± 15). Final follow-up will take place at visit 5 (day 90 ± 15). Questionnaires will be applied and photographs taken at all visits. Injections will be administered with poly-L-lactic acid in the mandibular angle region and anterior to the mandibular ligament. The study will be funded by the Research Department of the Hexsel Dermatology Clinic, and the data collected will be used to prepare an article for publication.
- Conditions
- Skin Laxity, Facial Aging
- Being tested
- PLLA application to the mandibular angle
- Keywords
- Restructuring the mandibular angle in facial aging: a new technique using poly-L-lactic acid (PLLA), PLLA, poly-L-lactic acid, mandibular angle, facial aging
- Medical subject headings
- Cutis Laxa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLLA application to the mandibular angleProcedure or surgery
The investigator will mark the application area by palpating the inferior and posterior boundaries of the face and the mandibular ramus, approximately 1 cm from these anatomical landmarks. The second PLLA injection point will be marked 1 cm from the inferior bony border of the mandible, anterior to the mandibular ligament. The demarcated area will be anesthetized with a local infiltration of 0.3-0.5 mL of 1% lidocaine with epinephrine, using a 30G needle. PLLA will then be reconstituted in 10 mL of sterile water for injection. Administration will be performed with a 30G needle inserted perpendicularly into the marked area until the supraperiosteal plane of the mandibular angle is reached, delivering a 0.7 mL bolus of the reconstituted product. At the second site-1 cm from the inferior bony border of the mandible, anterior to the mandibular ligament-a 0.2 mL dose of the reconstituted product will be injected.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The 46 research participants, of both sexes, aged between 18 and 65 years, will be allocated to a single group in which all individuals will receive the study treatment sessions in the mandibular region with PLLA. Receives: Procedure: PLLA application to the mandibular angle |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of a new poly-L-lactic acid application technique through supraperiosteal injections along the contour of the mandibular angle and in the region anterior to the mandibular ligament.
To evaluate, through standardized comparative photographs before and after treatment sessions, using the Global Aesthetic Improvement Scale (GAIS).
Measured: 90 days
Secondary outcomes (1)
Assess patient satisfaction. Evaluate the safety of a new poly-L-lactic acid technique with supraperiosteal injections in the mandibular angle. Assess short-term outcomes after two or three intervention sessions based on clinical indications.
Assess the percentage of patients satisfied according to the study satisfaction questionnaire.
Assess the overall frequency of adverse events related to the treatment and to the poly-L-lactic acid study product throughout the study period.
Assess the percentage of patients demonstrating clinical improvement of at least 1 point in the final skin quality rating, based on an ordinal scale scored from 0 to 5.
Assess the percentage of patients showing improvement in facial laxity using the Facial Laxity Grading Scale as assessed by the investigator.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study start1 Feb 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin LaxityStudies 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
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Doris Hexsel
- Sponsor type
- University, hospital or other
- Collaborators
- HEXSEL DERMATOLOGIC CLINICS RESEARCH DEPARTMENT
- Responsible party
- Sponsor-investigator, Doris Hexsel, Hexsel Dermatology Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06948045
- Sponsor's protocol ID
- 08DPCHD2501
- Status last verified
- Nov 2025
- First submitted
- 22 Apr 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restructuring the Mandibular Angle in Facial Aging: a Novel Tecnique Using Poly-L-Lactic Acid
- ClinicalTrials.gov ID
- NCT06948045
- Acronym / sponsor ID
- 08DPCHD2501
- Conditions
- Skin Laxity, Facial Aging
- Keywords
- Restructuring the mandibular angle in facial aging: a new technique using poly-L-lactic acid (PLLA), PLLA, poly-L-lactic acid, mandibular angle, facial aging
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Doris HexselUniversity, hospital or other
- Collaborators
- HEXSEL DERMATOLOGIC CLINICS RESEARCH DEPARTMENT
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 29 Apr 2025 (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 laxity is a common complaint among patients seeking aesthetic dermatological interventions, affecting the facial contour, especially in the mandibular angle, due to bone aging and the loss of tissue support in the lower third of the face. Facelift surgery is an effective method to address this issue, but it is invasive and may impact the definition of the jawline. As an alternative, poly-L-lactic acid (PLLA) stimulates collagen production, improving facial contour in a minimally invasive manner. This study aims to evaluate the safety and effectiveness of a new, low-cost, and quick application technique using poly-L-lactic acid in the mandibular angle and anterior to the mandibular ligament. The proposed technique seeks to enhance facial contour, provide an additional lifting effect, and contribute to overall facial rejuvenation. This is a clinical, prospective, and interventional study, allowing the analysis of clinical outcomes in terms of efficacy and safety. Twenty volunteers aged between 18 and 65, of both genders, with no restrictions on the use of collagen bio-stimulators, will be recruited. After confirming inclusion and exclusion criteria, participants will sign the Informed Consent Form (ICF) and be eligible for the study. The first intervention will occur at visit 2 (day 1), the second intervention at visit 3 (day 30 ± 15), and the third intervention will be performed as indicated at visit 4 (day 60 ± 15). Final follow-up will take place at visit 5 (day 90 ± 15). Questionnaires will be applied and photographs taken at all visits. Injections will be administered with poly-L-lactic acid in the mandibular angle region and anterior to the mandibular ligament. The study will be funded by the Research Department of the Hexsel Dermatology Clinic, and the data collected will be used to prepare an article for publication.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Procedure: PLLA application to the mandibular angleThe 46 research participants, of both sexes, aged between 18 and 65 years, will be allocated to a single group in which all individuals will receive the study treatment sessions in the mandibular region with PLLA. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female individuals aged between 18 and 65 years of age.
- Immunocompetent individuals.
- Medical history and physical examination that, in the opinion of the investigator, do not prevent or contraindicate participation in the study or the use of the investigational product.
- Female research participants of childbearing potential with a negative UPT at baseline (Day 1). These participants must use a highly effective contraceptive method throughout the study: combined oral contraceptives (estrogen and progesterone) or implanted/injectable contraceptives (with a stable dose for at least 1 month prior to study entry), bilateral tubal ligation, hormonal intrauterine device (inserted at least 1 month before entering the study), strict abstinence (at least 1 month prior to study entry and agreeing to continue throughout the study duration), vasectomized partner (at least 3 months before study entry), or condom use.
- Women not of childbearing potential (e.g. postmenopausal with no menstrual bleeding for 1 year prior to study entry, hysterectomy, or bilateral oophorectomy).
Key exclusion criteria (16 listed)
- Participants unable to understand the research protocol and/or follow the study schedule.
- Pregnant or breastfeeding women, or those planning to become pregnant during the study period.
- History of treatment in the past 6 months or planning to undergo procedures with lasers, intense pulsed light, radiofrequency, microfocused ultrasound, or deep chemical peels.
- History of treatment with botulinum toxin on the face in the past 6 months or planning to undergo this procedure.
- History of treatment with hyaluronic acid-based or other non-permanent dermal fillers on the face in the past 12 months, or planning to undergo this procedure.
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 |
|---|---|---|
| PLLA application to the mandibular angleThe investigator will mark the application area by palpating the inferior and posterior boundaries of the face and the mandibular ramus, approximately 1 cm from these anatomical landmarks. The second PLLA injection point will be marked 1 cm from the inferior bony border of the mandible, anterior to the mandibular ligament. The demarcated area will be anesthetized with a local infiltration of 0.3-0.5 mL of 1% lidocaine with epinephrine, using a 30G needle. PLLA will then be reconstituted in 10 mL of sterile water for injection. Administration will be performed with a 30G needle inserted perpendicularly into the marked area until the supraperiosteal plane of the mandibular angle is reached, delivering a 0.7 mL bolus of the reconstituted product. At the second site-1 cm from the inferior bony border of the mandible, anterior to the mandibular ligament-a 0.2 mL dose of the reconstituted product will be injected. | Procedure or surgery | Intervention group |
Primary outcome
To evaluate the efficacy of a new poly-L-lactic acid application technique through supraperiosteal injections along the contour of the mandibular angle and in the region anterior to the mandibular ligament.
Time frame: 90 days
To evaluate, through standardized comparative photographs before and after treatment sessions, using the Global Aesthetic Improvement Scale (GAIS).
1 secondary outcome
Assess patient satisfaction. Evaluate the safety of a new poly-L-lactic acid technique with supraperiosteal injections in the mandibular angle. Assess short-term outcomes after two or three intervention sessions based on clinical indications.
Time frame: 90 days
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 26 Nov 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing PLLA application to the mandibular angle in people with Skin Laxity and Facial Aging, run by Doris Hexsel.
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 7 inclusion and 16 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 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the efficacy of a new poly-L-lactic acid application technique through supraperiosteal injections along the contour of the mandibular angle and in the region anterior to the mandibular ligament. (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Nov 2025.