Histology Study of Biostimulatory Activity of Injectable Poly-L-Lactic Acid (Sculptra Aesthetic)

NCT04957446 | Unknown FDA Device

• 1 other identifier: SRG-PLLA-02
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Nasolabial Fold; Facial Wrinkles

Keywords

nasolabial fold; facial wrinkles

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (1)

• Skin Improvement

  18 weeks

Study Arms (2)

Group 1

EXPERIMENTAL

Subjects will receive 3 treatments of 1mL Poly-L-Lactic Acid (Sculptra Aesthetic)

Device: Sculptra Aesthetic

Group 2

PLACEBO COMPARATOR

Subjects will receive 3 treatments of 1mL Saline solution.

Other: Placebo

Interventions

Sculptra Aesthetic DEVICE

Injectable implant containing microparticles of poly-L-lactic acid (PLLA)

Group 1

Placebo OTHER

Saline solution

Group 2

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Sadick Research Group: lead
• Galderma R&D: collaborator

Study Sites (1)

Michelle Malanga

New York, New York, 10075, United States

RECRUITING

Study Officials

• Neil Sadick, M.D.

  Sadick Research Group

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle Malanga, MPA

CONTACT

2112-772-7242; mmalanga@sadickdermatology.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The investigator
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: June 22, 2021
• First Posted: July 12, 2021
• Study Start: August 9, 2021
• Primary Completion: July 1, 2022
• Study Completion: September 1, 2022
• Last Updated: August 11, 2021

Record last verified: 2021-06

Locations

US (1)