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

NCT05269654 | Unknown FDA Device

• 1 other identifier: Sculptra Aesthetic - Hip Dell
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Skin Laxity

Keywords

Skin; Volume; Volume Loss; Hips; Cosmetic

Outcome Measures

Primary Outcomes (15)

• Histological Analysis

  Comparison of measure of adipose tissue in biopsies taken from device and sham treated areas prior to baseline and at followup visits

  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

  Baseline to six months post final treatment

• Volumetric Analysis

  Analysis of tissue volume in treatment zones based on measurements obtained via 3D photography

  Pre-Treatment Visit 2/ Baseline

• Volumetric Analysis

  Analysis of tissue volume in treatment zones based on measurements obtained via 3D photography

  Pre-Treatment Visit 3/ Day 14

• Volumetric Analysis

  Analysis of tissue volume in treatment zones based on measurements obtained via 3D photography

  Pre-Treatment Visit 4/ Day 44

• Volumetric Analysis

  Analysis of tissue volume in treatment zones based on measurements obtained via 3D photography

  Pre-Treatment Visit 5/ Day 74

• Volumetric Analysis

  Analysis of tissue volume in treatment zones based on measurements obtained via 3D photography

  Visit 6/ Day 104

• Volumetric Analysis

  Analysis of tissue volume in treatment zones based on measurements obtained via 3D photography

  Visit 7/ Day 164

• Volumetric Analysis

  Analysis of tissue volume in treatment zones based on measurements obtained via 3D photography

  Visit 9/ Day 254

• Volumetric Analysis

  Analysis of tissue volume in treatment zones based on measurements obtained via 3D photography

  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

  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

  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

  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

  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

  9 Month Follow-Up visit

Secondary Outcomes (6)

• Collagen Analysis

  Upon analysis of biopsies collected at Day 0 and 3 and 6 Month Follow-Up visits

• Elastin Analysis

  Upon analysis of biopsies collected at Day 0 and 3 and 6 Month Follow-Up visits

• Skin Thickness

  Day 0 and 3, 6, and 9 Month Follow-Up visits

• Subject Global Aesthetic Improvement Score

  1, 3, 6, and 9 Month Follow-Up visits

• Subject Satisfaction Questionairre

  1, 3, 6, and 9 Month Follow-Up visits

Study Arms (2)

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).

Device: injectable poly-L-lactic acid

Normal Saline

SHAM COMPARATOR

One side of the subject's hips will be treated with injectable normal saline

Other: Normal Saline

Interventions

injectable poly-L-lactic acid DEVICE

Injectable biostimulant for volume loss

Also known as: PLLA, Sculptra, Sculptra Aesthetic, Galderma

injectable poly-L-lactic acid

Normal Saline OTHER

Sham Comparator

Normal Saline

Eligibility Criteria

• Age: 30 Years - 60 Years
• Gender Eligibility Details: Subjects must self-report as female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Goldman, Butterwick, Fitzpatrick and Groff: lead
• Galderma R&D: collaborator

Study Sites (1)

West Dermatology Research Center/Cosmetic Laser Dermatology

San Diego, California, 92121, United States

Location

MeSH Terms

Conditions

Cutis Laxa

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Subject and Outcome Assessor will be unaware of which side of the subject is treated with the study device and which is treated with saline.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Director

Model Details: This is a prospective, single-site, double-blinded, split-body, randomized controlled trial.

Study Record Dates

• First Submitted: February 4, 2022
• First Posted: March 8, 2022
• Study Start: March 4, 2022
• Primary Completion: December 31, 2023
• Study Completion: March 1, 2024
• Last Updated: March 8, 2022

Record last verified: 2022-02

Locations

US (1)