AgingNCT06337747
Comparing Injections With Poly-L-Lactic Acid in the Temporal Fossa vs. Extended Temporal Fossa + Hairline
A study testing Traditional technique and Experimental technique in people with Aging, run by Erevna Innovations Inc. at 1 site in Canada.
Trial summary
The use of poly-L-Lactic acid (PLLA) has demonstrated significant improvement in multiple facial and body regions. Its use in the temporal fossa is the ideal location to demonstrate its impact on neocollagenesis given its distinct anatomic boundaries. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Traditional technique and Experimental technique
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 19 May 2023to 23 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must voluntarily sign and date an informed consent, approved by an independent ethics committee, prior to the initiation of any screening or study-specific procedures.
- Subjects must be adult male or female, at least 18 years old.
- Subjects must be willing and able to comply with procedures required in the protocol.
- Subjects must be in good health as per investigator's judgment based on medical history.
- Subjects must have mild to severe temporal fossa hollowing.
- Subjects must not have uncontrolled systemic disease.
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- Subjects do not present with or have a history of any medical condition that may place the subject at increased risk following exposure to PLLA or interfere with the study evaluation, including:
- History of facial nerve palsy.
- Infection or dermatological condition at the treatment injection sites.
- Marked facial asymmetry, dermatochalasis, deep dermal scarring, excessively thick sebaceous skin, or excessively photodamaged skin.
- Any eyebrow or eyelid ptosis at Baseline as determined by the investigator.
- Subjects do not have history of clinically significant medical conditions or any other reason that the investigator determines would interfere with the subject's participation in this study or would make the subject an unsuitable candidate to receive study drug.
- Subjects do not have history of an allergic reaction or significant sensitivity to constituents of the study drug (or its excipients).
- Subjects must not have tattoos, jewelry, or clothing which obscure the temporal region and cannot be removed.
- Subjects do not have anticipated need for surgery or overnight hospitalization during the study.
- Subjects do not have a history of surgical procedures on forehead and/or periorbital areas or affecting these areas including any lifting procedure (e.g., facial lift, suture lift, thread lift, brow lift, eyelid and/or eyebrow surgery).
- Subjects do not have history of periorbital or upper-facial treatment with semi- permanent or permanent soft tissue fillers (e.g., poly-L-lactic acid, polyalkylimide, polymethylmethacrylate, polytetrafluoroethylene, and silicone), synthetic implantation and/or autologous fat transplantation.
- One month prior to enrolment: Subjects do not have any periorbital or upper-facial cosmetic procedures with superficial-to-medium resurfacing/planning (e.g., microdermabrasion, dermaplaning, dermabrasion), chemical peels (e.g., glycolic acid, trichloroacetic acid and phenol), or nonablative energy-based facial treatments (e.g., radiofrequency, ultrasound, electromagnetic, laser, light).
- Three months prior to enrolment: Subjects do not have ablative energy-based facial treatments or permanent make-up.
- Twelve months prior to enrolment: any periorbital or upper-facial treatment with nonpermanent soft tissue fillers (e.g., hyaluronic acid-based fillers, calcium hydroxylapatite, and collagen-based fillers).
- Subjects with known active COVID infection within 14 days of treatment.
- Female subjects of child-bearing potential must have a negative urine pregnancy test prior to any dose of study product.
- Female subjects of childbearing potential must practice at least 1 protocol-specified method of birth control that is effective from Baseline through at least 30 days after the last dose or until the end of study, whichever is longer. Female subjects of non-childbearing potential do not need to use birth control.
- Female subjects that are not pregnant or breastfeeding and are not considering becoming pregnant or donating eggs during the study or for approximately 30 days after the last dose of study drug or until the end of study, whichever is longer.
- Subjects must not have been treated with any investigational drug within 30 days prior to the first dose of study drug or is currently enrolled in another clinical study.
- Using or planning to initiate restrictive diets that could result in extreme fluctuations in weight (i.e., +/- 10 lbs), at investigator's discretion.
- Using or planning to initiate the use of supplements for weight loss.
- Using or have used within the previous 3 months drugs such as corticosteroids, immunosuppressants, anticoagulants or other collagen-production inhibitors.
- Initiated use of hormones or change in dose of hormonal replacement therapy within 3 months, due to possible implications on weight.
- Sculptra® Aesthetic should not be used in patients with known history of or susceptibility to keloid formation or hypertrophic scarring.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized-controlled Trial Comparing Superficial Injections With Poly-L-Lactic Acid in the Temporal Fossa Versus Extended Temporal Fossa + Hairline
The use of poly-L-Lactic acid (PLLA) has demonstrated significant improvement in multiple facial and body regions. Its use in the temporal fossa is the ideal location to demonstrate its impact on neocollagenesis given its distinct anatomic boundaries. Furthermore, the fact that the lateral boundary of the temporal region can extend into the hairline allows for a graded effect to be measured. Therefore, this study aims to extend these findings by evaluating the efficacy and safety of two injection techniques for volumizing temporal hollows.
Read the detailed description
Non-invasive treatment of volume loss is one of the most common aesthetic treatments performed worldwide. Poly-L-lactic acid has been used as a skin filler since 1999 in Europe and since 2004 in the United States (Vlegger, 2014), as well as in several medical areas for over three decades (Chen, 2014; Vlegger, 2006) In addition, poly-L-lactic acid is widely used in several countries for facial rejuvenation, with extensive documentation of their efficacy and safety in this context (Vlegger, 2014). Sculptra® Aesthetic is an injectable implant containing microparticles of poly-L-lactic acid, carboxymethylcellulose, non-pyrogenic mannitol and sterile water for injection. Sculptra® Aesthetic is available in 367.5 mg dose vials and is to be reconstituted prior to use by the addition of 8 mL of sterile water + 1mL xylocaine for injection to form a sterile nonpyrogenic suspension.
Sculptra® Aesthetic is indicated for increasing the volume of depressed areas, particularly to correct skin depressions such as in skin creases, wrinkles, folds, scars and for skin aging. It is also suitable for large volume corrections of the signs of facial fat loss (lipoatrophy). Poly-L-lactic acid is capable of increasing the dermal tissue through stimulating production of collagen, contributing to filling, volumizing in the treated area (Lowe, 2006; Vlegger, 2014). Unlike other skin fillers that promote volume increase shortly after injection (e.g., HA), poly-L-lactic acid exerts its effect over the course of a few weeks. This effect is usually visible after two months and noticeable up to two years after treatment (Chen, 2014; Vlegger, 2006; Vlegger, 2014)
The use of poly-l-lactic acid (PLLA) has demonstrated significant improvement in multiple facial and body regions. Its use in the temporal fossa is the ideal location to demonstrate its impact on neocollagenesis given its distinct anatomic boundaries. Furthermore, the fact that the lateral boundary of the temporal region can extend into the hairline allows for a graded effect to be measured. Therefore, this study aims to extend these findings by evaluating the efficacy and safety of two injection techniques for volumizing temporal hollows.
- Conditions
- Aging
- Being tested
- Traditional technique, Experimental technique
- Keywords
- Temple, Poly-L-lactic acid, Aesthetic, Dermal fillers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional techniqueDevice
Subjects randomized to the traditional technique will receive 3cc of PLLA (per side, per treatment) in the anterior temporal region.
Experimental techniqueDevice
Subjects randomized to the extended technique will receive 3cc of PLLA (per side, per treatment) in the anterior temporal region, as well as 2cc (per side, per treatment) in the posterior (i.e., behind the hairline) temporal region.
| Study group | Role | What they receive |
|---|---|---|
| Traditional technique | Active comparator | Not described Receives: Device: Traditional technique |
| Extended technique | Experimental | Not described Receives: Device: Experimental technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
To access the efficacy of the tradition and experimental technique
To assess the efficacy of poly-l-lactic acid for volumization of the temporal fossae, between standard and extended techniques at all follow-up visits.
Measured: Baseline to Week 7, Week 14, Week 20, Week 28, Week 38
Secondary outcomes (1)
To access the safety of the tradition and experimental technique
To assess the safety of poly-l-lactic acid for volumization of the temporal fossae between the standard and extended techniques, at all visits.
Measured: Baseline to Week 7, Week 14, Week 20, Week 28, Week 38
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start19 May 2023
- Primary completion23 Apr 2024
- Study completion23 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for 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
- Randomised
- Intervention model
- Single group
- Model description
- A prospective, randomized-controlled trial
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erevna Innovations Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06337747
- Sponsor's protocol ID
- 04-2023-PLLA
- Status last verified
- Jun 2023
- First submitted
- 23 May 2023
- Last updated
- 5 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen HH, Javadi P, Daines SM, Williams EF 3rd. Quantitative assessment of the longevity of poly-L-lactic acid as a volumizing filler using 3-dimensional photography. JAMA Facial Plast Surg. 2015 Jan-Feb;17(1):39-43. doi: 10.1001/jamafacial.2014.867.
PubMed 25340593Lowe NJ. Dispelling the myth: appropriate use of poly-L-lactic acid and clinical considerations. J Eur Acad Dermatol Venereol. 2006 May;20 Suppl 1:2-6. doi: 10.1111/j.1468-3083.2006.01515.x.
PubMed 16643417Vleggaar D. Soft-tissue augmentation and the role of poly-L-lactic acid. Plast Reconstr Surg. 2006 Sep;118(3 Suppl):46S-54S. doi: 10.1097/01.prs.0000234846.00139.74.
PubMed 16936544Vleggaar D, Fitzgerald R, Lorenc ZP. Composition and mechanism of action of poly-L-lactic acid in soft tissue augmentation. J Drugs Dermatol. 2014 Apr;13(4 Suppl):s29-31.
PubMed 24719074Ali A. Contouring of the gluteal region in women: enhancement and augmentation. Ann Plast Surg. 2011 Sep;67(3):209-14. doi: 10.1097/SAP.0b013e318206595b.
PubMed 21587056
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized-controlled Trial Comparing Superficial Injections With Poly-L-Lactic Acid in the Temporal Fossa Versus Extended Temporal Fossa + Hairline
- ClinicalTrials.gov ID
- NCT06337747
- Acronym / sponsor ID
- 04-2023-PLLA
- Conditions
- Aging
- Keywords
- Temple, Poly-L-lactic acid, Aesthetic, Dermal fillers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Erevna Innovations Inc.University, hospital or other
- Study start
- 19 May 2023 (actual)
- Primary completion
- 23 Apr 2024 (actual)
- Study completion
- 23 Apr 2024 (actual)
- First posted
- 29 Mar 2024 (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.
The use of poly-L-Lactic acid (PLLA) has demonstrated significant improvement in multiple facial and body regions. Its use in the temporal fossa is the ideal location to demonstrate its impact on neocollagenesis given its distinct anatomic boundaries. Furthermore, the fact that the lateral boundary of the temporal region can extend into the hairline allows for a graded effect to be measured. Therefore, this study aims to extend these findings by evaluating the efficacy and safety of two injection techniques for volumizing temporal hollows.
Detailed description
Non-invasive treatment of volume loss is one of the most common aesthetic treatments performed worldwide. Poly-L-lactic acid has been used as a skin filler since 1999 in Europe and since 2004 in the United States (Vlegger, 2014), as well as in several medical areas for over three decades (Chen, 2014; Vlegger, 2006) In addition, poly-L-lactic acid is widely used in several countries for facial rejuvenation, with extensive documentation of their efficacy and safety in this context (Vlegger, 2014). Sculptra® Aesthetic is an injectable implant containing microparticles of poly-L-lactic acid, carboxymethylcellulose, non-pyrogenic mannitol and sterile water for injection. Sculptra® Aesthetic is available in 367.5 mg dose vials and is to be reconstituted prior to use by the addition of 8 mL of sterile water + 1mL xylocaine for injection to form a sterile nonpyrogenic suspension.
Sculptra® Aesthetic is indicated for increasing the volume of depressed areas, particularly to correct skin depressions such as in skin creases, wrinkles, folds, scars and for skin aging. It is also suitable for large volume corrections of the signs of facial fat loss (lipoatrophy). Poly-L-lactic acid is capable of increasing the dermal tissue through stimulating production of collagen, contributing to filling, volumizing in the treated area (Lowe, 2006; Vlegger, 2014). Unlike other skin fillers that promote volume increase shortly after injection (e.g., HA), poly-L-lactic acid exerts its effect over the course of a few weeks. This effect is usually visible after two months and noticeable up to two years after treatment (Chen, 2014; Vlegger, 2006; Vlegger, 2014)
The use of poly-l-lactic acid (PLLA) has demonstrated significant improvement in multiple facial and body regions. Its use in the temporal fossa is the ideal location to demonstrate its impact on neocollagenesis given its distinct anatomic boundaries. Furthermore, the fact that the lateral boundary of the temporal region can extend into the hairline allows for a graded effect to be measured. Therefore, this study aims to extend these findings by evaluating the efficacy and safety of two injection techniques for volumizing temporal hollows.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A prospective, randomized-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Traditional technique | Active comparator | Device: Traditional technique |
| Extended technique | Experimental | Device: Experimental technique |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- Subjects must voluntarily sign and date an informed consent, approved by an independent ethics committee, prior to the initiation of any screening or study-specific procedures.
- Subjects must be adult male or female, at least 18 years old.
- Subjects must be willing and able to comply with procedures required in the protocol.
- Subjects must be in good health as per investigator's judgment based on medical history.
- Subjects must have mild to severe temporal fossa hollowing.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Traditional techniqueSubjects randomized to the traditional technique will receive 3cc of PLLA (per side, per treatment) in the anterior temporal region. | Device | Traditional technique |
| Experimental techniqueSubjects randomized to the extended technique will receive 3cc of PLLA (per side, per treatment) in the anterior temporal region, as well as 2cc (per side, per treatment) in the posterior (i.e., behind the hairline) temporal region. | Device | Extended technique |
Primary outcome
To access the efficacy of the tradition and experimental technique
Time frame: Baseline to Week 7, Week 14, Week 20, Week 28, Week 38
To assess the efficacy of poly-l-lactic acid for volumization of the temporal fossae, between standard and extended techniques at all follow-up visits.
1 secondary outcome
To access the safety of the tradition and experimental technique
Time frame: Baseline to Week 7, Week 14, Week 20, Week 28, Week 38
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
- Background: PubMed 25340593Chen HH, Javadi P, Daines SM, Williams EF 3rd. Quantitative assessment of the longevity of poly-L-lactic acid as a volumizing filler using 3-dimensional photography. JAMA Facial Plast Surg. 2015 Jan-Feb;17(1):39-43. doi: 10.1001/jamafacial.2014.867.
- Background: PubMed 16643417Lowe NJ. Dispelling the myth: appropriate use of poly-L-lactic acid and clinical considerations. J Eur Acad Dermatol Venereol. 2006 May;20 Suppl 1:2-6. doi: 10.1111/j.1468-3083.2006.01515.x.
- Background: PubMed 16936544Vleggaar D. Soft-tissue augmentation and the role of poly-L-lactic acid. Plast Reconstr Surg. 2006 Sep;118(3 Suppl):46S-54S. doi: 10.1097/01.prs.0000234846.00139.74.
- Background: PubMed 24719074Vleggaar D, Fitzgerald R, Lorenc ZP. Composition and mechanism of action of poly-L-lactic acid in soft tissue augmentation. J Drugs Dermatol. 2014 Apr;13(4 Suppl):s29-31.
- Background: PubMed 21587056Ali A. Contouring of the gluteal region in women: enhancement and augmentation. Ann Plast Surg. 2011 Sep;67(3):209-14. doi: 10.1097/SAP.0b013e318206595b.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional technique and Experimental technique in people with Aging, run by Erevna Innovations Inc. at 1 site in Canada.
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 30 inclusion and 0 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: finished, as of the sponsor's last update on 5 Aug 2024. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 access the efficacy of the tradition and experimental technique (time frame: Baseline to Week 7, Week 14, Week 20, Week 28, Week 38). 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 NCT06337747, which also lists 5 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 5 Aug 2024.