Evaluate the Effectiveness and Safety of Restylane Volyme in the Treatment of Temple Hollowing

NCT06665477 | Recruiting

• 1 other identifier: 43CH2401
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized, no-treatment-controlled, evaluator-blinded, multi-center study to evaluate the effectiveness and safety of Restylane Volyme in the treatment of temple hollowing

Conditions

Temple Hollowing

Outcome Measures

Primary Outcomes (1)

• Responder Rate on a Temple Hollowing Scale

  A treatment responder is defined as a participant with at least a one-grade improvement from baseline on both temples concurrently on the Galderma Temple Volume Deficit Scale (GTVDS, a 4-grade scale rangings are none (0), mild (1), moderate (2), severe (3) temple hollowing) as assessed by the Blinded Evaluator at 6 months after last treatment for the Treatment group and 6 months after baseline for the Control group.

  6 months

Secondary Outcomes (3)

• Responder Rate on a Temple Hollowing Scale

  3, 9 and 12 months

• Proportion of Participants Improved

  3, 6, 9 and 12 months

• Proportion of Participants Improved

  3 and 6 months

Study Arms (2)

Subject treated with Restylane Volyme

EXPERIMENTAL

Device: Restylane Volyme

Subject non-treated with Restylane Volyme

NO INTERVENTION

Interventions

Restylane Volyme DEVICE

Subjects in Restylane Volyme treatment group will receive treatment on Day 1 and optiponal treatment 1 month later.

Subject treated with Restylane Volyme

Eligibility Criteria

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

You may qualify if:

• Ability to adequately understand the verbal explanations and the written subject information provided in local language and ability and willingness to give consent to participate in the study. Signed and dated informed consent to participate in the study.
• Males or non-pregnant, non-breastfeeding females of Chinese origin and 18 years of age or older at the time of signing the Informed Consent Form (ICF).
• Grade 2 (moderate) to 3 (severe) on the 4-grade GTVDS for both temples as assessed by the Blinded Evaluator as well as the Treating Investigator on Day 1 (agreement on grade is not required). The GTVDS grade for the right temple and the left temple does not have to be equal but must not differ by more than 1 grade.
• Willing to abstain from any other facial plastic surgical or cosmetic procedures above the level of the horizontal line from subnasale for the duration of the study (e.g., laser or chemical resurfacing, needling, facelift, lifting threads, radiofrequency etc.).
• Intent to undergo treatment for correction of temple hollowing.
• If the subject is a female of childbearing potential, she agrees to use an acceptable form of effective birth control for the duration of the study and is willing to take a urine pregnancy test (UPT) or a serum HCG (blood test \[if UPT is not available\]) at screening, baseline and prior to receiving any study treatment.
• Acceptable forms of effective birth control include:
• Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical caps) with spermicidal foam/gel/film/cream/suppository;
• Bilateral tubal ligation;
• Combined oral contraceptives (estrogens and progesterone), implanted or injectable contraceptives on a stable dose for at least 28 days prior to Day 1;
• Hormonal or copper intra uterine device (IUD) inserted at least 28 days prior to Day 1;
• Vasectomized partner (in monogamous relationship) for at least 3 months prior to screening;
• Strict abstinence (at least one month prior to baseline and agrees to continue for the duration of the study or use acceptable form of birth control).
• Negative pregnancy test for women of childbearing potential at the screening and baseline visits.

You may not qualify if:

• Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel or to gram positive bacterial proteins.
• Known/previous allergy or hypersensitivity to local anesthetics, e.g., lidocaine or other amide-type anesthetics or nerve blocking agents (if intended to be used for that subject).
• Previous or present severe or multiple allergies manifested by severe reactions, such as anaphylaxis or angioedema, or family history of these conditions.
• Previous facial surgery (e.g., facelift) above the level of the horizontal line from subnasale that in the Treating Investigator´s opinion could interfere with the study safety and/or effectiveness assessments.
• Any previous aesthetic procedures or implants:
• Previous permanent filler or implant, lifting threads, or autologous fat in the face regardless of time.
• Previous use of calcium hydroxylapatite (CaHA) or poly-L-lactic acid (PLLA) above the level of the horizontal line from subnasale within 24 months.
• Previous HA filler or collagen filler above the level of the horizontal line from subnasale within 12 months.
• Previous botulinum toxin treatment above the level of the horizontal line from subnasale within 6 months.
• Previous energy based aesthetic procedures (e.g., laser, intense pulsed light, radiofrequency, photomodulation and ultrasound) above the level of the horizontal line from subnasale within 6 months.
• Previous mechanical (e.g., dermabrasion, needling) or chemical aesthetic procedures (e.g., chemical peel) above the level of the horizontal line from subnasale within 6 months.
• Previous treatment with cryotherapy above the level of the horizontal line from subnasale within 6 months.
• History of cancer or previous radiation above the level of the horizontal line from subnasale.
• Presence of any disease or lesions near or on the area to be treated, e.g.:
• Inflammation, active or chronic infection (e.g., in mouth, dentals, head, eye);

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (1)

Galderma Investigational Site #6340

Beijing, Beijing Municipality, 100000, China

RECRUITING

Central Study Contacts

Galderma Research & Development

CONTACT

817-961-5000; clinical.studies@galderma.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: October 30, 2024
• Study Start: November 18, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 17, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)