Nasolabial FoldNCT04957446
Histology Study of Biostimulatory Activity of Injectable Poly-L-Lactic Acid (Sculptra Aesthetic)
A study testing Sculptra Aesthetic in people with Nasolabial Fold and Facial Wrinkles, run by Sadick Research Group at 1 site in United States.
Trial summary
The study device, Sculptra, is an injectable implant formulation of poly-L-lactic acid microbeads, approved by the FDA for treatment of facial fat loss (lipoatrophy of HIV disease). It is being used off-label by dermatologists to treat dermal defects, as a biologically active filler. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Nasolabial Fold, Facial Wrinkles
- What is being tested?
- Sculptra Aesthetic
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2021to 1 Sep 2022
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- 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 females an males between 30 and 65 years of age
- Subjects with Fitzpatrick photo skin types I-IV
- Subjects with shallow to deep nasolabial fold contour deficiencies or other facial wrinkles
- Subjects who agree not to have any procedures affecting facial wrinkles (e.g. filler, botulinum toxin, radiofrequency, laser, IPL, 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, IUD, 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
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Michelle Malanga
New York, New York, 10075
Michelle Malanga, PhD, 212-772-7242, mmalanga@sadickdermatology.com
Neil S Sadick, MD
About this study
Official title: A Clinical Histology Study Evaluating Biostimulatory Activity Longevity of Injectable Poly-L-Lactic Acid (Sculptra Aesthetic) for Facial Rejuvenation
The study device, Sculptra, is an injectable implant formulation of poly-L-lactic acid microbeads, approved by the FDA for treatment of facial fat loss (lipoatrophy of HIV disease). It is being used off-label by dermatologists to treat dermal defects, as a biologically active filler. Anecdotal evidence suggests that subjects' skin quality may improve as a result of poly-L-lactic acid injection. While this is not the primary goal of such treatments it is often seen and described as so called "Sculptra glow". Based upon the study doctor's experience global skin quality improvement includes radiance, smoothness and pigment uniformity as well as a decrease in skin redness and pore size. In this study we evaluate the existence of histopathological (microscopic examination of tissue) evidence that can explain the observed improvement of skin quality after poly-L-lactic acid injections. Specifically, we will use histopathologic techniques to investigate effects of Sculptra injections into human skin with regard to restoring skin health and epidermal thickness.
Read the detailed description
Sculptra is a formulation of poly-L-lactic acid microbeads, approved by the FDA for treatment of facial fat loss (lipoatrophy of HIV disease). It is being used off-label by dermatologists to treat dermal defects, as a biologically active filler. Anecdotal evidence suggests that patients' skin quality may improve as a result of poly-L-lactic acid injection. While this is not the primary goal of such treatments it is often seen and described as so called "Sculptra glow".
Based upon the investigator's experience global skin quality improvement includes radiance, smoothness and pigment uniformity as well as a decrease of erythema index and pore size. In this study we evaluate the existence of histopathological evidence that can elucidate the observed improvement of skin quality after poly-L-lactic acid injections. Specifically we will use histopathologic techniques to investigate effects of Sculptra injections into human skin with regard to dermal remodeling and epidermal thickness.This is a randomized, controlled, double-blind single-center study. The treatment phase will consist of a baseline visit, visits at 4-week and 8-weeks during which eligible subjects will receive injections of 5 cc of poly-L-lactic acid (PLLA) for the treatment group or saline for the control group into both sides of the face.
Seven eligible subjects will receive injections of 5 cc of poly-L-lactic acid (PLLA) for the study treatment group and 3 subjects will receive saline for the control group into both sides of the face.
The biopsy portion of the study, a punch biopsy will be collected at 4 timepoints throughout the study: at baseline prior to study treatment one, 4 weeks post study treatment one, 48 hours post study treatment three, and 18 weeks post study treatment.
Participation is up to 28 weeks and will attend approximately 6 study visits. The subject participation period includes a screening period of up to 2 weeks, three injections at 4-week intervals, and a follow-up visit at 48 hours and 18 weeks after the last injection.
to evaluate the histological effect and the "duration" of repeated subcutaneous injections of poly-L-lactic acid (PLLA) on skin quality. As skin SRG-PLLA-02 quality improvement the histopathological analysis with assess expression of procollagen 1, CD31 (vessels), SMA (myofibroblasts), CD163 (macrophages), CD117 (mast cells), \& Elastin.
- Conditions
- Nasolabial Fold, Facial Wrinkles
- Being tested
- Sculptra Aesthetic, Placebo
- Keywords
- nasolabial fold, facial wrinkles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sculptra AestheticDevice
Injectable implant containing microparticles of poly-L-lactic acid (PLLA)
PlaceboOther
Saline solution
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Subjects will receive 3 treatments of 1mL Poly-L-Lactic Acid (Sculptra Aesthetic) Receives: Device: Sculptra Aesthetic |
| Group 2 | Placebo comparator | Subjects will receive 3 treatments of 1mL Saline solution. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histological effect
The primary outcome measure is defined as the degree of improvement in skin quality based on the expression of tissue markers measured by a blinded histopathologist.
Measured: 12 weeks
Secondary outcomes (1)
Skin Improvement
The secondary outcome measure is defined as the degree of improvement in skin quality measured by a blinded, trained evaluator using standardized pictures as well as live evaluations rated by a blinded investigator and the subjects.
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start9 Aug 2021
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasolabial FoldStudies 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
- Parallel groups
- Model description
- This is a randomized, controlled, double-blind single-center study. Subjects will be randomized to either Group 1 (Sculptra Aesthetic) or Group 2 Placebo (Saline solution).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sadick Research Group
- Sponsor type
- University, hospital or other
- Collaborators
- Galderma R&D
- Responsible party
- Sponsor
- Investigators
- Neil Sadick, M.D., Principal investigator, Sadick Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04957446
- Sponsor's protocol ID
- SRG-PLLA-02
- Status last verified
- Jun 2021
- First submitted
- 22 Jun 2021
- Last updated
- 11 Aug 2021
- 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 11 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Histology Study Evaluating Biostimulatory Activity Longevity of Injectable Poly-L-Lactic Acid (Sculptra Aesthetic) for Facial Rejuvenation
- ClinicalTrials.gov ID
- NCT04957446
- Acronym / sponsor ID
- SRG-PLLA-02
- Conditions
- Nasolabial Fold, Facial Wrinkles
- Keywords
- nasolabial fold, facial wrinkles
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Sadick Research GroupUniversity, hospital or other
- Collaborators
- Galderma R&D
- Study start
- 9 Aug 2021 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 12 Jul 2021 (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 study device, Sculptra, is an injectable implant formulation of poly-L-lactic acid microbeads, approved by the FDA for treatment of facial fat loss (lipoatrophy of HIV disease). It is being used off-label by dermatologists to treat dermal defects, as a biologically active filler. Anecdotal evidence suggests that subjects' skin quality may improve as a result of poly-L-lactic acid injection. While this is not the primary goal of such treatments it is often seen and described as so called "Sculptra glow". Based upon the study doctor's experience global skin quality improvement includes radiance, smoothness and pigment uniformity as well as a decrease in skin redness and pore size. In this study we evaluate the existence of histopathological (microscopic examination of tissue) evidence that can explain the observed improvement of skin quality after poly-L-lactic acid injections. Specifically, we will use histopathologic techniques to investigate effects of Sculptra injections into human skin with regard to restoring skin health and epidermal thickness.
Detailed description
Sculptra is a formulation of poly-L-lactic acid microbeads, approved by the FDA for treatment of facial fat loss (lipoatrophy of HIV disease). It is being used off-label by dermatologists to treat dermal defects, as a biologically active filler. Anecdotal evidence suggests that patients' skin quality may improve as a result of poly-L-lactic acid injection. While this is not the primary goal of such treatments it is often seen and described as so called "Sculptra glow".
Based upon the investigator's experience global skin quality improvement includes radiance, smoothness and pigment uniformity as well as a decrease of erythema index and pore size. In this study we evaluate the existence of histopathological evidence that can elucidate the observed improvement of skin quality after poly-L-lactic acid injections. Specifically we will use histopathologic techniques to investigate effects of Sculptra injections into human skin with regard to dermal remodeling and epidermal thickness.This is a randomized, controlled, double-blind single-center study. The treatment phase will consist of a baseline visit, visits at 4-week and 8-weeks during which eligible subjects will receive injections of 5 cc of poly-L-lactic acid (PLLA) for the treatment group or saline for the control group into both sides of the face.
Seven eligible subjects will receive injections of 5 cc of poly-L-lactic acid (PLLA) for the study treatment group and 3 subjects will receive saline for the control group into both sides of the face.
The biopsy portion of the study, a punch biopsy will be collected at 4 timepoints throughout the study: at baseline prior to study treatment one, 4 weeks post study treatment one, 48 hours post study treatment three, and 18 weeks post study treatment.
Participation is up to 28 weeks and will attend approximately 6 study visits. The subject participation period includes a screening period of up to 2 weeks, three injections at 4-week intervals, and a follow-up visit at 48 hours and 18 weeks after the last injection.
to evaluate the histological effect and the "duration" of repeated subcutaneous injections of poly-L-lactic acid (PLLA) on skin quality. As skin SRG-PLLA-02 quality improvement the histopathological analysis with assess expression of procollagen 1, CD31 (vessels), SMA (myofibroblasts), CD163 (macrophages), CD117 (mast cells), \& Elastin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is a randomized, controlled, double-blind single-center study. Subjects will be randomized to either Group 1 (Sculptra Aesthetic) or Group 2 Placebo (Saline solution).
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: Sculptra AestheticSubjects will receive 3 treatments of 1mL Poly-L-Lactic Acid (Sculptra Aesthetic) |
| Group 2 | Placebo comparator | Other: PlaceboSubjects will receive 3 treatments of 1mL Saline solution. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 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 females an males between 30 and 65 years of age
- Subjects with Fitzpatrick photo skin types I-IV
- Subjects with shallow to deep nasolabial fold contour deficiencies or other facial wrinkles
- Subjects who agree not to have any procedures affecting facial wrinkles (e.g. filler, botulinum toxin, radiofrequency, laser, IPL, ultrasound) 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, IUD, 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 AestheticInjectable implant containing microparticles of poly-L-lactic acid (PLLA) | Device | Group 1 |
| PlaceboSaline solution | Other | Group 2 |
Primary outcome
Histological effect
Time frame: 12 weeks
The primary outcome measure is defined as the degree of improvement in skin quality based on the expression of tissue markers measured by a blinded histopathologist.
1 secondary outcome
Skin Improvement
Time frame: 18 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2021.
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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.
Neil Sadick, M.D. principal investigator
Sadick Research Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sculptra Aesthetic in people with Nasolabial Fold and Facial Wrinkles, run by Sadick Research Group at 1 site in United States.
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 8 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 11 Aug 2021. 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 United States. 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. Some participants in this study may receive a placebo. 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 Michelle Malanga, MPA (2112-772-7242 ext. 2, mmalanga@sadickdermatology.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histological effect (time frame: 12 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 11 Aug 2021.