LipoatrophyNCT05608239
Safety and Efficacy of Injectable Poly-L-Lactic Acid for Volume Loss in the Temples Using Dual Plane Injections
A study testing Sculptra aesthetic in people with Lipoatrophy and Aging, run by Sadick Research Group.
Trial summary
Temporal volume loss is part of the natural aging process of the face. It is primarily the consequence of fat pad atrophy, but bone loss, ligament weakening, soft tissue, and muscle also contribute. . The goal of the study is to evaluate the volumizing and bio-stimulatory effects of sculptra injections in the temples. Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lipoatrophy, Aging
- What is being tested?
- Sculptra aesthetic
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Nov 2022to Nov 2023
- 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 25 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects who are able to give voluntary, written informed consent to participate in this study and from whom consent has been obtained including HIPAA authorization
- Healthy males or females over 25 years old with temporal hollows volume deficit of Grade 2 to 4 on the Galderma Temple Volume Deficit Scale
- Subjects with Fitzpatrick photo skin types I-IV
- Subjects who agree not to have any procedures affecting facial wrinkles (e.g. filler, botulinum toxin, radiofrequency, laser, intense-pulsed light, ultrasound) for the duration of the study
- Subjects who do agree not to have any other procedures affecting skin quality (microdermabrasion, peels, acne treatments, etc.) for the duration of the study
- Subjects who understand this study and are able to follow study instructions and are willing to attend the required study visits
- Subjects who agree to be photographed for research reasons and their identity may not be concealed in these photographs.
Who cannot join
- Subjects who are pregnant, planning to become pregnant or breastfeeding. A urine pregnancy test will be done to rule out pregnancy
- Subjects of child-bearing potential who are not using an approved method of birth control (oral contraceptives, intrauterine device, contraceptive implant, barrier methods with spermicide or abstinence). Females of non-childbearing potential are defined as post-menopausal (absence of menstrual bleeding for one year), hysterectomy or bilateral oophorectomy.
- Subjects who cannot understand or are not willing to comply with the requirements of the study
- Subjects who have a known allergy to poly-L-lactic acid, carboxymethylcellulose, non-pyrogenic mannitol or any anesthetic
- Subjects who have taken any NSAIDs (aspirin, ibuprofen, etc.) within 7 days before treatment
- Subjects who have taken acetaminophen 24 hours before treatment
Show all 20Show fewer
- Subjects who have had fillers or botulinum toxin in the treatment area in the past 12 months
- Subjects who have had treatments with poly-L-lactic acid in the face at any time
- Subjects who have had any kind of facial dermabrasion, chemical peel, laser, or IPL treatment including superficial treatments for aesthetic reasons in the past 6 months or for the duration of the study
- Subjects who does not agree to avoid using tanning beds or intensive exposure to the sun 2 two weeks prior to each office visit.
- Subjects who have any dermatologic conditions including acne, rosacea, eczema, psoriasis, actinic keratosis, severe sun damage, infection or scars within the treatment area
- Subjects who have an active inflammatory process (skin eruptions such as cysts, pimples, rashes or hives) or infection within the treatment area
- Subjects who have any known cancer including skin cancers (basal cell carcinoma, squamous cell carcinoma and melanoma)
- Subjects who have had systemic corticosteroid therapy in the past 6 months or for the duration of the study
- Subjects with a known history of poor wound healing
- Subjects with a known history of keloids (excessive scarring)
- Subjects who are HIV positive
- Subjects who have an existing medical condition that the Investigator considers may put the subject at risk or compromise their participation in the study
- Subjects who have participated in another research study in the past 30 days
- Subjects who are currently involved in any injury litigation claims
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prospective, Single-site, Open Label Study to Assess the Safety and Efficacy of Injectable Poly-L-Lactic Acid (Sculptra Aesthetic) for Volume Loss in the Temples Using Dual Plane Injections
Temporal volume loss is part of the natural aging process of the face. It is primarily the consequence of fat pad atrophy, but bone loss, ligament weakening, soft tissue, and muscle also contribute. . The goal of the study is to evaluate the volumizing and bio-stimulatory effects of sculptra injections in the temples.
Read the detailed description
This is a prospective, single-site, open label study to assess the safety and efficacy of injectable Poly-L-Lactic Acid (Sculptra aesthetic) for volume loss in the temples using dual plane injections. Eligible subjects will get up to 3 treatments four weeks apart with poly-L-lactic acid, (Sculptra) in the temples. After the treatments, subjects will return to the research site 1 month and 6 months post last treatment for follow up visits.Eligible subjects will get up to 3 treatment sessions 4 weeks apart with ether Sculptra® Aesthetic or saline following a randomized list. During the study period, subjects will return to the research site for visits at 5 and 6 months post baseline (±7 days).
- Conditions
- Lipoatrophy, Aging
- Being tested
- Sculptra aesthetic
- Medical subject headings
- Lipodystrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sculptra aestheticDevice
The goal of the study is to evaluate the volumizing and bio-stimulatory effects of sculptra injections in the temples with total volume of the diluted product as 9 ml (8 ml of sterile water and 1 ml of Lidocaine).
| Study group | Role | What they receive |
|---|---|---|
| Sculptra® Aesthetic | Experimental | Not described Receives: Device: Sculptra aesthetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical evaluation of PLLA injection for efficacy, to restore the volume loss in temporal area
at least one degree of improvement in the temporal area volume using the Galderma Temple Volume Deficit Scale (Moradi et al Dermatol Surg. 2020 Sep;46(9): 1148-1154) and GAIS at the last follow up as compared to baseline.
Measured: 16 weeks
Secondary outcomes (2)
Improvement of facial skin laxity
Improvement of facial skin laxity will be defined as at least 1 point of improvement in the facial area using the 10-point facial laxity rating scale (Silva Hector, Dermatol Surg.2016 Dec;42(12):1370-1379) from baseline throughout week 36.
Measured: 16 weeks
Adverse events
Safety will be assessed throughout the study by monitoring adverse events clinically and by Ultrasound imaging.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study startNov 2022 (estimated)
- Primary completionJul 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LipoatrophyStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sadick Research Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05608239
- Sponsor's protocol ID
- SadickRG
- Status last verified
- Nov 2022
- First submitted
- 2 Nov 2022
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single-site, Open Label Study to Assess the Safety and Efficacy of Injectable Poly-L-Lactic Acid (Sculptra Aesthetic) for Volume Loss in the Temples Using Dual Plane Injections
- ClinicalTrials.gov ID
- NCT05608239
- Acronym / sponsor ID
- SadickRG
- Conditions
- Lipoatrophy, Aging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sadick Research GroupUniversity, hospital or other
- Study start
- Nov 2022 (estimated)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 8 Nov 2022 (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.
Temporal volume loss is part of the natural aging process of the face. It is primarily the consequence of fat pad atrophy, but bone loss, ligament weakening, soft tissue, and muscle also contribute. . The goal of the study is to evaluate the volumizing and bio-stimulatory effects of sculptra injections in the temples.
Detailed description
This is a prospective, single-site, open label study to assess the safety and efficacy of injectable Poly-L-Lactic Acid (Sculptra aesthetic) for volume loss in the temples using dual plane injections. Eligible subjects will get up to 3 treatments four weeks apart with poly-L-lactic acid, (Sculptra) in the temples. After the treatments, subjects will return to the research site 1 month and 6 months post last treatment for follow up visits.Eligible subjects will get up to 3 treatment sessions 4 weeks apart with ether Sculptra® Aesthetic or saline following a randomized list. During the study period, subjects will return to the research site for visits at 5 and 6 months post baseline (±7 days).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sculptra® Aesthetic | Experimental | Device: Sculptra aesthetic |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects who are able to give voluntary, written informed consent to participate in this study and from whom consent has been obtained including HIPAA authorization
- Healthy males or females over 25 years old with temporal hollows volume deficit of Grade 2 to 4 on the Galderma Temple Volume Deficit Scale
- Subjects with Fitzpatrick photo skin types I-IV
- Subjects who agree not to have any procedures affecting facial wrinkles (e.g. filler, botulinum toxin, radiofrequency, laser, intense-pulsed light, ultrasound) for the duration of the study
- Subjects who do agree not to have any other procedures affecting skin quality (microdermabrasion, peels, acne treatments, etc.) for the duration of the study
Key exclusion criteria (20 listed)
- Subjects who are pregnant, planning to become pregnant or breastfeeding. A urine pregnancy test will be done to rule out pregnancy
- Subjects of child-bearing potential who are not using an approved method of birth control (oral contraceptives, intrauterine device, contraceptive implant, barrier methods with spermicide or abstinence). Females of non-childbearing potential are defined as post-menopausal (absence of menstrual bleeding for one year), hysterectomy or bilateral oophorectomy.
- Subjects who cannot understand or are not willing to comply with the requirements of the study
- Subjects who have a known allergy to poly-L-lactic acid, carboxymethylcellulose, non-pyrogenic mannitol or any anesthetic
- Subjects who have taken any NSAIDs (aspirin, ibuprofen, etc.) within 7 days before treatment
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 |
|---|---|---|
| Sculptra aestheticThe goal of the study is to evaluate the volumizing and bio-stimulatory effects of sculptra injections in the temples with total volume of the diluted product as 9 ml (8 ml of sterile water and 1 ml of Lidocaine). | Device | Sculptra® Aesthetic |
Primary outcome
Clinical evaluation of PLLA injection for efficacy, to restore the volume loss in temporal area
Time frame: 16 weeks
at least one degree of improvement in the temporal area volume using the Galderma Temple Volume Deficit Scale (Moradi et al Dermatol Surg. 2020 Sep;46(9): 1148-1154) and GAIS at the last follow up as compared to baseline.
2 secondary outcomes
Improvement of facial skin laxity
Time frame: 16 weeks
Adverse events
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Sculptra aesthetic in people with Lipoatrophy and Aging, run by Sadick Research Group.
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 20 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: status not confirmed, as of the sponsor's last update on 8 Nov 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Neil Sadick, MD (2127727242, nssderm@sadickdermatology.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical evaluation of PLLA injection for efficacy, to restore the volume loss in temporal area (time frame: 16 weeks). 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 8 Nov 2022.