Recruiting

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

Sponsor:

Sadick Research Group

Code:

NCT04957446

Conditions

Nasolabial Fold

Facial Wrinkles

Eligibility Criteria

Sex: All

Age: 30 - 65

Healthy Volunteers: Not accepted

Interventions

Sculptra Aesthetic

Placebo

Study Details

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

Study ID

NCT04957446

Start date

Aug 9, 2021

Status verified date

Jun, 2021

Completion date

Sep 1, 2022

Anticipated

Primary completion date

Jul 1, 2022

Anticipated

Eligibility Criteria

Sex: All

Age: 30 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

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
Subjects with a known history of keloids (excessive scarring)
Subjects who are HIV positive
Subjects who have an existing medical condition that the Investigator considers may put the subject at risk or compromise their participation in the study
Subjects who have participated in another research study in the past 30 days
Subjects who are currently involved in any injury litigation claims

Study Design

Enrollment

10 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group 1

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

placebo comparator: Group 2

Subjects will receive 3 treatments of 1mL Saline solution.

Interventions

Sculptra Aesthetic

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

Placebo

Saline solution

Primary outcome measure

Histological effect [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Michelle Malanga, MPA

2112-772-7242 mmalanga@sadickdermatology.com

Locations

Michelle Malanga

Recruiting

New York, New York, United States, 10075

Contacts

Michelle Malanga, PhD

212-772-7242 mmalanga@sadickdermatology.com

Principal Investigator:

Neil S Sadick, MD

More Information

Sponsor

Sadick Research Group

Last update posted

Aug 11, 2021

Last verified

Jun, 2021

Keywords

nasolabial fold
facial wrinkles

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sadick Research Group on 2021-08-11.