Safety and Efficacy of Injectable Poly-L-Lactic Acid for Volume Loss in the Temples Using Dual Plane Injections

NCT05608239 | Unknown

• 1 other identifier: SadickRG
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

Temporal volume loss is part of the natural aging process of the face. It is primarily the consequence of fat pad atrophy, but bone loss, ligament weakening, soft tissue, and muscle also contribute. . The goal of the study is to evaluate the volumizing and bio-stimulatory effects of sculptra injections in the temples.

Conditions

Lipoatrophy; Aging

Outcome Measures

Primary Outcomes (1)

• Clinical evaluation of PLLA injection for efficacy, to restore the volume loss in temporal area

  at least one degree of improvement in the temporal area volume using the Galderma Temple Volume Deficit Scale (Moradi et al Dermatol Surg. 2020 Sep;46(9): 1148-1154) and GAIS at the last follow up as compared to baseline.

  16 weeks

Secondary Outcomes (2)

• Improvement of facial skin laxity

  16 weeks

• Adverse events

  16 weeks

Study Arms (1)

Sculptra® Aesthetic

EXPERIMENTAL

Device: Sculptra aesthetic

Interventions

Sculptra aesthetic DEVICE

The goal of the study is to evaluate the volumizing and bio-stimulatory effects of sculptra injections in the temples with total volume of the diluted product as 9 ml (8 ml of sterile water and 1 ml of Lidocaine).

Sculptra® Aesthetic

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: Yes
• 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 males or females over 25 years old with temporal hollows volume deficit of Grade 2 to 4 on the Galderma Temple Volume Deficit Scale
• Subjects with Fitzpatrick photo skin types I-IV
• Subjects who agree not to have any procedures affecting facial wrinkles (e.g. filler, botulinum toxin, radiofrequency, laser, intense-pulsed light, 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, intrauterine device, 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

MeSH Terms

Conditions

Lipodystrophy

Condition Hierarchy (Ancestors)

Skin Diseases, Metabolic; Skin Diseases; Skin and Connective Tissue Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Neil Sadick, MD

CONTACT

2127727242; nssderm@sadickdermatology.com

Namrata Oza

CONTACT

2127727242; noza@sadickdermatology.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2022
• First Posted: November 8, 2022
• Study Start: November 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: November 1, 2023
• Last Updated: November 8, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share