Actively Recruiting
Evaluate the Effectiveness and Safety of Restylane Volyme in the Treatment of Temple Hollowing
Led by Galderma R&D · Updated on 2025-01-17
162
Participants Needed
1
Research Sites
84 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Evaluate the Effectiveness and Safety of Restylane Volyme in the Treatment of Temple Hollowing
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand study information and willing to give consent
- Male or non-pregnant, non-breastfeeding female of Chinese origin aged 18 years or older
- Moderate to severe temple hollowing (Grade 2 to 3) on both temples as assessed by evaluators
- Willing to avoid other facial cosmetic or surgical procedures above the subnasale horizontal line during the study
- Plan to undergo treatment for temple hollowing
- For females of childbearing potential: agree to use effective birth control during the study and take pregnancy tests at screening and before treatments
- Negative pregnancy test at screening and baseline for women of childbearing potential
You will not qualify if you...
- Allergy or hypersensitivity to injectable hyaluronic acid gel, gram positive bacterial proteins, local anesthetics, or nerve blocking agents
- History of severe allergies including anaphylaxis or angioedema
- Previous facial surgery above the subnasale horizontal line that may affect safety or assessments
- Previous permanent facial fillers, implants, lifting threads, or fat injections
- Recent facial aesthetic procedures (various types) within specified time frames before study
- History of cancer or radiation above the subnasale horizontal line
- Presence of active infections, skin conditions, scars, deformities, or cancer near treatment area
- Susceptibility to keloid formation, hyperpigmentation, or hypertrophic scarring
- Facial hair or tattoos interfering with injections or assessments
- History of migraines, temporomandibular joint disorders, or related pain in treatment area
- Temple hollowing caused by trauma, congenital malformations, or lipodystrophy
- Recent trauma to temple area within 6 months
- History or presence of temporal arteritis
- Dental or facial conditions interfering with treatment or assessments
- Abnormal temple firmness, structure, or symmetry
- Underlying diseases or conditions posing undue risk
- Use of medications affecting bleeding within 14 days before injection
- Recent chemotherapy, immunosuppressive agents, or corticosteroids
- Use of facial corticosteroids or retinoids near treatment area within specified times
- Conditions preventing study completion or protocol compliance
- Study personnel or relatives of study personnel
- Participation in other interventional clinical trials within 30 days before treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Galderma Investigational Site #6340
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
Research Team
G
Galderma Research & Development
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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