Skin LaxityNCT05269654
Injectable Poly-L-Lactic Acid for Volumization and Adipogenesis of the Hip Dell
A study testing injectable poly-L-lactic acid and Normal Saline in people with Skin Laxity, run by Goldman, Butterwick, Fitzpatrick and Groff at 1 site in United States.
Trial summary
To assess the safety, efficacy and subject satisfaction associated with volumization of the hip dell with injectable poly-L-lactic acid (PLLA), or Sculptra® Aesthetic (Galderma Laboratories, Fort Worth, TX). Read more about this study
- Who is it for?
- Ages 30 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Laxity
- What is being tested?
- injectable poly-L-lactic acid and Normal Saline
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2022to 1 Mar 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 30 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult females aged 30 to 60 years
- Subjects in good general health based on investigator's judgment and medical history
- Moderate to severe hip dell volume deficit as determined by the investigators
- Must be willing to give and sign an informed consent form and photographic release form
- Must have a stable body weight for at least six (6) months prior to study entry
- Must be willing to maintain usual sun exposure, diet, and exercise routines for the duration of the study
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- Subject agrees to avoid tanning or use of sunless tanner during the entire course of the study
- Negative urine pregnancy test result at the time of study entry (if applicable)
- For female subjects of childbearing potential, must be willing to use an acceptable form of birth control during the entire course of the study. All systemic birth control measures must be in consistent use for at least 30 days prior to study enrollment.
- A female is considered of childbearing potential unless she is postmenopausal, without a uterus and/or both ovaries, or has had a bilateral tubal ligation.
- Acceptable methods of birth control are: oral contraceptives, contraceptive patches/rings/implants, Implanon®, Depo-Provera®, double-barrier methods (e.g., condoms and spermicide), abstinence, and/or vasectomy of partner with a documented second acceptable method of birth control, should the subject become sexually active.
- Must be willing to comply with study treatments and complete the entire course of the study
Who cannot join
- Liposuction to bilateral hips, flanks, thighs, buttocks during the 12-month period prior to study treatment or any time during the course of the study
- Mesotherapy, dermal fillers, biostimulatory injectables, fat grafting, radiofrequency device treatments, microfocused ultrasound device treatments, laser and light-based device treatments, microneedling, cryolipolysis, high intensity focused electromagnetic energy device treatment, or surgery (i.e., lower body lift, buttocks augmentation, abdominoplasty, etc.) during the 12-month period before study treatment c) Any investigational treatment for a volume deficit of the bilateral hip dell areas during the 12-month period before the study treatment d) Massage therapy during the 3-month period before study treatment. e) Creams/cosmeceuticals and/or home therapies to promote plumping of the bilateral hip dell area during the four-week period before study treatment f) Subjects with scarring in the treatment areas g) History of thrombosis, post-thrombosis syndrome, or any vascular disorder of the bilateral lower extremities
- Any history of bleeding or coagulation disorders i) Subjects with tattoos or permanent implants in the treatment areas j) Subjects with a significant history or current evidence of a medical, psychological, or other disorder that, in the investigator's opinion, would preclude enrollment into the study
- Subjects with a history of or presence of any skin condition/disease (including but not limited to any visible rash, atopic dermatitis, psoriasis, actinic keratoses, keratinocyte carcinoma, melanoma, etc.) in the treatment area that might interfere with the diagnosis or evaluation of study parameters
- History of keloid or hypertrophic scarring
- Subjects with an active bacterial, viral, or fungal infection of the treatment areas
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- Subjects who spray tanned or used sunless tanners in the treatment areas four (4) weeks prior to study treatment
- History of lidocaine sensitivity deemed by the investigator to preclude the subject from enrolling into the study
- Subjects planning any cosmetic procedure to the treatment areas during the study period, other than the treatment that will be performed by the investigator
- Presence of incompletely healed wound(s) in the treatment area
- Subjects who are on an immunosuppressant or have an autoimmune condition
- Female subjects who are pregnant, planning a pregnancy, or breast feeding during the study
- Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study
Trial locations and contacts
1 site in 1 country.
United States1 site
West Dermatology Research Center/Cosmetic Laser Dermatology
San Diego, California, 92121
About this study
Official title: A Single Center, Double-Blinded, Split-Body, Randomized Clinical Trial of Injectable Poly-L-Lactic Acid for Volumization and Adipogenesis of the Hip Dell
To assess the safety, efficacy and subject satisfaction associated with volumization of the hip dell with injectable poly-L-lactic acid (PLLA), or Sculptra® Aesthetic (Galderma Laboratories, Fort Worth, TX).
Read the detailed description
The primary objectives of this clinical trial is to assess efficacy of adipose tissue generation (adipogenesis) and volumization following treatment of the hip dell with injectable poly-L-lactic acid (PLLA, Sculptra® Aesthetic; Galderma Laboratories; Fort Worth, TX).
Enrolled subjects will be randomized to two (2) treatment groups: "right hip dell treated" and "left hip dell treated". All subjects will receive three (3), single-sided injections of Sculptra® Aesthetic (Galderma Laboratories; Fort Worth, TX), performed one (1) month ± 7 days apart. Treatments will be provided to one side randomly assigned to either "right side" or "left side". The non-treatment side will receive bacteriostatic saline, injected in the same manner as Sculptra® Aesthetic. One (1) vial of Sculptra® Aesthetic, diluted to 8mL, will be used per treatment session.
Subjects satisfying all inclusion and no exclusion criteria will be enrolled in this trial. Prior to receiving any study treatment, mandatory digital photography with overhead lighting and VECTRA® (Canfield Scientific, Inc.; Parsippany, NJ) 3D volumetric body photography will be obtained of each subject's treatment area. In order to participate in the study, subjects must provide written informed consent to have their photographs used for research, publication, and/or commercial purposes.
- Conditions
- Skin Laxity
- Being tested
- injectable poly-L-lactic acid, Normal Saline
- Keywords
- Skin, Volume, Volume Loss, Hips, Cosmetic
- Medical subject headings
- Cutis Laxa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
injectable poly-L-lactic acidDevice
Also called PLLA, Sculptra, Sculptra Aesthetic, Galderma
Injectable biostimulant for volume loss
Normal SalineOther
Sham Comparator
| Study group | Role | What they receive |
|---|---|---|
| injectable poly-L-lactic acid | Experimental | One side of the subject's hips will be treated with injectable poly-L-lactic acid (PLLA, Sculptra® Aesthetic; Galderma Laboratories; Fort Worth, TX). Receives: Device: injectable poly-L-lactic acid |
| Normal Saline | Sham comparator | One side of the subject's hips will be treated with injectable normal saline Receives: Other: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histological Analysis
Comparison of measure of adipose tissue in biopsies taken from device and sham treated areas prior to baseline and at followup visits
Measured: Baseline to three months post final treatment
Histological Analysis
Comparison of measure of adipose tissue in biopsies taken from device and sham treated areas prior to baseline and at followup visits
Measured: Baseline to six months post final treatment
Volumetric Analysis
Analysis of tissue volume in treatment zones based on measurements obtained via 3D photography
Measured: Pre-Treatment Visit 2/ Baseline
Volumetric Analysis
Analysis of tissue volume in treatment zones based on measurements obtained via 3D photography
Measured: Pre-Treatment Visit 3/ Day 14
Volumetric Analysis
Analysis of tissue volume in treatment zones based on measurements obtained via 3D photography
Measured: Pre-Treatment Visit 4/ Day 44
Volumetric Analysis
Analysis of tissue volume in treatment zones based on measurements obtained via 3D photography
Measured: Pre-Treatment Visit 5/ Day 74
Volumetric Analysis
Analysis of tissue volume in treatment zones based on measurements obtained via 3D photography
Measured: Visit 6/ Day 104
Volumetric Analysis
Analysis of tissue volume in treatment zones based on measurements obtained via 3D photography
Measured: Visit 7/ Day 164
Volumetric Analysis
Analysis of tissue volume in treatment zones based on measurements obtained via 3D photography
Measured: Visit 9/ Day 254
Volumetric Analysis
Analysis of tissue volume in treatment zones based on measurements obtained via 3D photography
Measured: Visit 11/ Day 344
Physician Global Aesthetic Improvement Scale
Blinded-Evaluator assessment of change in appearance of treated areas where 1 + Very Much Improved, 2 = Much Improved, 3 = Improved, 4 = No Change, and 5 = Worse
Measured: 1 Month Follow-Up visit
Physician Global Aesthetic Improvement Scale
Blinded-Evaluator assessment of change in appearance of treated areas where 1 + Very Much Improved, 2 = Much Improved, 3 = Improved, 4 = No Change, and 5 = Worse
Measured: 3 Month Follow-Up visit
Physician Global Aesthetic Improvement Scale
Blinded-Evaluator assessment of change in appearance of treated areas where 1 + Very Much Improved, 2 = Much Improved, 3 = Improved, 4 = No Change, and 5 = Worse
Measured: 6 Month Follow-Up visit
Physician Global Aesthetic Improvement Scale
Blinded-Evaluator assessment of change in appearance of treated areas where 1 + Very Much Improved, 2 = Much Improved, 3 = Improved, 4 = No Change, and 5 = Worse
Measured: 9 Month Follow-Up visit
Identification of correct Treatment Area (Right vs Left Hip)
Blinded-Evaluator performed assessment of which side received study treatment and which received sham
Measured: 9 Month Follow-Up visit
Secondary outcomes (6)
Collagen Analysis
Quantitative analysis of collagen amounts based on histology
Measured: Upon analysis of biopsies collected at Day 0 and 3 and 6 Month Follow-Up visits
Elastin Analysis
Quantitative analysis of elastin amounts based on histology
Measured: Upon analysis of biopsies collected at Day 0 and 3 and 6 Month Follow-Up visits
Skin Thickness
Ultrasound imaging measurements of skin thickness/thickness of dermis
Measured: Day 0 and 3, 6, and 9 Month Follow-Up visits
Subject Global Aesthetic Improvement Score
Subject assessment of change in appearance of treated areas rated numerically from 1 to 5 with 1 being very much improved to 5 being worse
Measured: 1, 3, 6, and 9 Month Follow-Up visits
Subject Satisfaction Questionairre
Degree of subject satisfaction with treatment outcomes rated numerically from 0 to 4 with 0 being not satisfied to 4 being extremely satisfied
Measured: 1, 3, 6, and 9 Month Follow-Up visits
Evaluation of Side Effects
Assessment of treatment related adverse events by Investigator
Measured: Day 44, Day 74, Day 104, Day 164, Day 178, Day 254, Day 268, Day 433
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start4 Mar 2022 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion1 Mar 2024 (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
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, single-site, double-blinded, split-body, randomized controlled trial.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Goldman, Butterwick, Fitzpatrick and Groff
- Sponsor type
- University, hospital or other
- Collaborators
- Galderma R&D
- Responsible party
- Principal investigator, Sherif Mikhail, MD, Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05269654
- Sponsor's protocol ID
- Sculptra Aesthetic - Hip Dell
- Status last verified
- Feb 2022
- First submitted
- 4 Feb 2022
- Last updated
- 8 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Double-Blinded, Split-Body, Randomized Clinical Trial of Injectable Poly-L-Lactic Acid for Volumization and Adipogenesis of the Hip Dell
- ClinicalTrials.gov ID
- NCT05269654
- Acronym / sponsor ID
- Sculptra Aesthetic - Hip Dell
- Conditions
- Skin Laxity
- Keywords
- Skin, Volume, Volume Loss, Hips, Cosmetic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Goldman, Butterwick, Fitzpatrick and GroffUniversity, hospital or other
- Collaborators
- Galderma R&D
- Study start
- 4 Mar 2022 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 8 Mar 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.
To assess the safety, efficacy and subject satisfaction associated with volumization of the hip dell with injectable poly-L-lactic acid (PLLA), or Sculptra® Aesthetic (Galderma Laboratories, Fort Worth, TX).
Detailed description
The primary objectives of this clinical trial is to assess efficacy of adipose tissue generation (adipogenesis) and volumization following treatment of the hip dell with injectable poly-L-lactic acid (PLLA, Sculptra® Aesthetic; Galderma Laboratories; Fort Worth, TX).
Enrolled subjects will be randomized to two (2) treatment groups: "right hip dell treated" and "left hip dell treated". All subjects will receive three (3), single-sided injections of Sculptra® Aesthetic (Galderma Laboratories; Fort Worth, TX), performed one (1) month ± 7 days apart. Treatments will be provided to one side randomly assigned to either "right side" or "left side". The non-treatment side will receive bacteriostatic saline, injected in the same manner as Sculptra® Aesthetic. One (1) vial of Sculptra® Aesthetic, diluted to 8mL, will be used per treatment session.
Subjects satisfying all inclusion and no exclusion criteria will be enrolled in this trial. Prior to receiving any study treatment, mandatory digital photography with overhead lighting and VECTRA® (Canfield Scientific, Inc.; Parsippany, NJ) 3D volumetric body photography will be obtained of each subject's treatment area. In order to participate in the study, subjects must provide written informed consent to have their photographs used for research, publication, and/or commercial purposes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a prospective, single-site, double-blinded, split-body, randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| injectable poly-L-lactic acid | Experimental | Device: injectable poly-L-lactic acidOne side of the subject's hips will be treated with injectable poly-L-lactic acid (PLLA, Sculptra® Aesthetic; Galderma Laboratories; Fort Worth, TX). |
| Normal Saline | Sham comparator | Other: Normal SalineOne side of the subject's hips will be treated with injectable normal saline |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Adult females aged 30 to 60 years
- Subjects in good general health based on investigator's judgment and medical history
- Moderate to severe hip dell volume deficit as determined by the investigators
- Must be willing to give and sign an informed consent form and photographic release form
- Must have a stable body weight for at least six (6) months prior to study entry
Key exclusion criteria (13 listed)
- Liposuction to bilateral hips, flanks, thighs, buttocks during the 12-month period prior to study treatment or any time during the course of the study
- Mesotherapy, dermal fillers, biostimulatory injectables, fat grafting, radiofrequency device treatments, microfocused ultrasound device treatments, laser and light-based device treatments, microneedling, cryolipolysis, high intensity focused electromagnetic energy device treatment, or surgery (i.e., lower body lift, buttocks augmentation, abdominoplasty, etc.) during the 12-month period before study treatment c) Any investigational treatment for a volume deficit of the bilateral hip dell areas during the 12-month period before the study treatment d) Massage therapy during the 3-month period before study treatment. e) Creams/cosmeceuticals and/or home therapies to promote plumping of the bilateral hip dell area during the four-week period before study treatment f) Subjects with scarring in the treatment areas g) History of thrombosis, post-thrombosis syndrome, or any vascular disorder of the bilateral lower extremities
- Any history of bleeding or coagulation disorders i) Subjects with tattoos or permanent implants in the treatment areas j) Subjects with a significant history or current evidence of a medical, psychological, or other disorder that, in the investigator's opinion, would preclude enrollment into the study
- Subjects with a history of or presence of any skin condition/disease (including but not limited to any visible rash, atopic dermatitis, psoriasis, actinic keratoses, keratinocyte carcinoma, melanoma, etc.) in the treatment area that might interfere with the diagnosis or evaluation of study parameters
- History of keloid or hypertrophic scarring
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 |
|---|---|---|
| injectable poly-L-lactic acidAlso: PLLA, Sculptra, Sculptra Aesthetic, GaldermaInjectable biostimulant for volume loss | Device | injectable poly-L-lactic acid |
| Normal SalineSham Comparator | Other | Normal Saline |
Primary outcome
Histological Analysis
Time frame: Baseline to three months post final treatment
Comparison of measure of adipose tissue in biopsies taken from device and sham treated areas prior to baseline and at followup visits
Histological Analysis
Time frame: Baseline to six months post final treatment
Comparison of measure of adipose tissue in biopsies taken from device and sham treated areas prior to baseline and at followup visits
Volumetric Analysis
Time frame: Pre-Treatment Visit 2/ Baseline
Analysis of tissue volume in treatment zones based on measurements obtained via 3D photography
Volumetric Analysis
Time frame: Pre-Treatment Visit 3/ Day 14
Analysis of tissue volume in treatment zones based on measurements obtained via 3D photography
Volumetric Analysis
Time frame: Pre-Treatment Visit 4/ Day 44
Analysis of tissue volume in treatment zones based on measurements obtained via 3D photography
Volumetric Analysis
Time frame: Pre-Treatment Visit 5/ Day 74
Analysis of tissue volume in treatment zones based on measurements obtained via 3D photography
Volumetric Analysis
Time frame: Visit 6/ Day 104
Analysis of tissue volume in treatment zones based on measurements obtained via 3D photography
Volumetric Analysis
Time frame: Visit 7/ Day 164
Analysis of tissue volume in treatment zones based on measurements obtained via 3D photography
Volumetric Analysis
Time frame: Visit 9/ Day 254
Analysis of tissue volume in treatment zones based on measurements obtained via 3D photography
Volumetric Analysis
Time frame: Visit 11/ Day 344
Analysis of tissue volume in treatment zones based on measurements obtained via 3D photography
Physician Global Aesthetic Improvement Scale
Time frame: 1 Month Follow-Up visit
Blinded-Evaluator assessment of change in appearance of treated areas where 1 + Very Much Improved, 2 = Much Improved, 3 = Improved, 4 = No Change, and 5 = Worse
Physician Global Aesthetic Improvement Scale
Time frame: 3 Month Follow-Up visit
Blinded-Evaluator assessment of change in appearance of treated areas where 1 + Very Much Improved, 2 = Much Improved, 3 = Improved, 4 = No Change, and 5 = Worse
Physician Global Aesthetic Improvement Scale
Time frame: 6 Month Follow-Up visit
Blinded-Evaluator assessment of change in appearance of treated areas where 1 + Very Much Improved, 2 = Much Improved, 3 = Improved, 4 = No Change, and 5 = Worse
Physician Global Aesthetic Improvement Scale
Time frame: 9 Month Follow-Up visit
Blinded-Evaluator assessment of change in appearance of treated areas where 1 + Very Much Improved, 2 = Much Improved, 3 = Improved, 4 = No Change, and 5 = Worse
Identification of correct Treatment Area (Right vs Left Hip)
Time frame: 9 Month Follow-Up visit
Blinded-Evaluator performed assessment of which side received study treatment and which received sham
6 secondary outcomes
Collagen Analysis
Time frame: Upon analysis of biopsies collected at Day 0 and 3 and 6 Month Follow-Up visits
Elastin Analysis
Time frame: Upon analysis of biopsies collected at Day 0 and 3 and 6 Month Follow-Up visits
Skin Thickness
Time frame: Day 0 and 3, 6, and 9 Month Follow-Up visits
Subject Global Aesthetic Improvement Score
Time frame: 1, 3, 6, and 9 Month Follow-Up visits
Subject Satisfaction Questionairre
Time frame: 1, 3, 6, and 9 Month Follow-Up visits
Evaluation of Side Effects
Time frame: Day 44, Day 74, Day 104, Day 164, Day 178, Day 254, Day 268, Day 433
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
- Individual participant dataSharing planned: Undecided
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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 injectable poly-L-lactic acid and Normal Saline in people with Skin Laxity, run by Goldman, Butterwick, Fitzpatrick and Groff 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 12 inclusion and 13 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 Mar 2022. 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?
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?
Histological Analysis (time frame: Baseline to three months post final treatment). The study lists 15 primary outcomes in all. 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 Mar 2022.