Status unknownNCT05269654Updated Mar 8, 2022

Injectable Poly-L-Lactic Acid for Volumization and Adipogenesis of the Hip Dell

An interventional study of injectable poly-L-lactic acid and Normal Saline in Skin Laxity, sponsored by Goldman, Butterwick, Fitzpatrick and Groff. Status unknown at 1 site in United States. Open to female participants aged 30 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-08.

Sponsored by Goldman, Butterwick, Fitzpatrick and Groff · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2022), so the status shown — last known as Not yet recruiting — may be out of date.

Phase: Not applicable
Study type: Interventional
Enrollment: 20
Allocation: Randomized
Ages: 30 Years to 60 Years
Sex: Female

Study 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 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 studied

Skin Laxity

Browse trials for

Cutis Laxa 151

Keywords

Skin
Volume
Volume Loss
Hips
Cosmetic

In context

Cutis Laxa

151 studies on the registry are indexed under Cutis Laxa; 36 are open to participants now.

This study's planned enrollment of 20 is below the median of 30 across 133 interventional studies indexed under Cutis Laxa.

Browse Cutis Laxa studies →

Lead sponsor

Goldman, Butterwick, Fitzpatrick and Groff is the lead sponsor of 41 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 30 Years to 60 Years
Sexes eligible: Female
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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
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

Exclusion criteria

Exclusion Criteria:

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
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

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Outcomes assessor)
Enrollment: 20 participants (estimated)

Study arms

Experimental
injectable poly-L-lactic acid
One side of the subject's hips will be treated with injectable poly-L-lactic acid (PLLA, Sculptra® Aesthetic; Galderma Laboratories; Fort Worth, TX).
Device: injectable poly-L-lactic acid
Sham comparator
Normal Saline
One side of the subject's hips will be treated with injectable normal saline
Other: Normal Saline

Interventions

Deviceinjectable poly-L-lactic acid
Injectable biostimulant for volume loss
Also known as: PLLA, Sculptra, Sculptra Aesthetic, Galderma
OtherNormal Saline
Sham Comparator

What researchers measure

Primary outcomes

Histological Analysis
Comparison of measure of adipose tissue in biopsies taken from device and sham treated areas prior to baseline and at followup visits
Time frame: 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
Time frame: Baseline to six months post final treatment
Volumetric Analysis
Analysis of tissue volume in treatment zones based on measurements obtained via 3D photography
Time frame: Pre-Treatment Visit 2/ Baseline
Volumetric Analysis
Analysis of tissue volume in treatment zones based on measurements obtained via 3D photography
Time frame: Pre-Treatment Visit 3/ Day 14
Volumetric Analysis
Analysis of tissue volume in treatment zones based on measurements obtained via 3D photography
Time frame: Pre-Treatment Visit 4/ Day 44
Volumetric Analysis
Analysis of tissue volume in treatment zones based on measurements obtained via 3D photography
Time frame: Pre-Treatment Visit 5/ Day 74
Volumetric Analysis
Analysis of tissue volume in treatment zones based on measurements obtained via 3D photography
Time frame: Visit 6/ Day 104
Volumetric Analysis
Analysis of tissue volume in treatment zones based on measurements obtained via 3D photography
Time frame: Visit 7/ Day 164
Volumetric Analysis
Analysis of tissue volume in treatment zones based on measurements obtained via 3D photography
Time frame: Visit 9/ Day 254
Volumetric Analysis
Analysis of tissue volume in treatment zones based on measurements obtained via 3D photography
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 9 Month Follow-Up visit

Secondary outcomes

Collagen Analysis
Quantitative analysis of collagen amounts based on histology
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 1, 3, 6, and 9 Month Follow-Up visits
Evaluation of Side Effects
Assessment of treatment related adverse events by Investigator
Time frame: Day 44, Day 74, Day 104, Day 164, Day 178, Day 254, Day 268, Day 433

Study locations

1 site

West Dermatology Research Center/Cosmetic Laser Dermatology
San Diego, California 92121, United States

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05269654
Lead sponsor: Goldman, Butterwick, Fitzpatrick and Groff
Collaborators: Galderma R&D
Responsible party: Sherif Mikhail, MD (Research Director, Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.) — Principal investigator
First posted: Mar 8, 2022
Start date: Mar 4, 2022 (estimated)
Primary completion: Dec 31, 2023 (estimated)
Completion: Mar 1, 2024 (estimated)
Last update: Mar 8, 2022

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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