Clinical trial NCT05269654: Injectable Poly-L-Lactic Acid for Volumization and Adipogenesis of the Hip Dell
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Skin Laxity
Keywords: Skin
Volume
Volume Loss
Hips
Cosmetic
Lead sponsor: Goldman, Butterwick, Fitzpatrick and Groff
Sponsor class: OTHER
Collaborators: name: Galderma R&D
First posted: 2022-03-08
Enrollment: 20
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective, single-site, double-blinded, split-body, randomized controlled trial.
Primary purpose: TREATMENT

Brief 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).

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.

Eligibility criteria: 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:

* 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

Primary outcomes:
measure: Histological Analysis
timeFrame: Baseline to three months post final treatment
measure: Histological Analysis
timeFrame: Baseline to six months post final treatment
measure: Volumetric Analysis
timeFrame: Pre-Treatment Visit 2/ Baseline
measure: Volumetric Analysis
timeFrame: Pre-Treatment Visit 3/ Day 14
measure: Volumetric Analysis
timeFrame: Pre-Treatment Visit 4/ Day 44
measure: Volumetric Analysis
timeFrame: Pre-Treatment Visit 5/ Day 74
measure: Volumetric Analysis
timeFrame: Visit 6/ Day 104
measure: Volumetric Analysis
timeFrame: Visit 7/ Day 164
measure: Volumetric Analysis
timeFrame: Visit 9/ Day 254
measure: Volumetric Analysis
timeFrame: Visit 11/ Day 344
measure: Physician Global Aesthetic Improvement Scale
timeFrame: 1 Month Follow-Up visit
measure: Physician Global Aesthetic Improvement Scale
timeFrame: 3 Month Follow-Up visit
measure: Physician Global Aesthetic Improvement Scale
timeFrame: 6 Month Follow-Up visit
measure: Physician Global Aesthetic Improvement Scale
timeFrame: 9 Month Follow-Up visit
measure: Identification of correct Treatment Area (Right vs Left Hip)
timeFrame: 9 Month Follow-Up visit
Secondary outcomes:
measure: Collagen Analysis
timeFrame: Upon analysis of biopsies collected at Day 0 and 3 and 6 Month Follow-Up visits
measure: Elastin Analysis
timeFrame: Upon analysis of biopsies collected at Day 0 and 3 and 6 Month Follow-Up visits
measure: Skin Thickness
timeFrame: Day 0 and 3, 6, and 9 Month Follow-Up visits
measure: Subject Global Aesthetic Improvement Score
timeFrame: 1, 3, 6, and 9 Month Follow-Up visits
measure: Subject Satisfaction Questionairre
timeFrame: 1, 3, 6, and 9 Month Follow-Up visits
measure: Evaluation of Side Effects
timeFrame: Day 44, Day 74, Day 104, Day 164, Day 178, Day 254, Day 268, Day 433
Other outcomes:
Locations:
city: San Diego
country: United States
facility: West Dermatology Research Center/Cosmetic Laser Dermatology
state: California
Study officials:
References: