Actively Recruiting
A Prospective, Multicenter, Randomized, No-treatment Controlled, Assessor-blinded, Superiority Clinical Trial to Evaluate the Efficacy and Safety of Polycaprolactone Gel for Injection to Improve Temple Hollowing in Chinese Adults
Led by AQTIS Medical B.V. · Updated on 2025-05-15
159
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Prospective, Multicenter, Randomized, No-treatment controlled, Assessor-blinded, Superiority Clinical Trial to Evaluate the Efficacy and Safety of Polycaprolactone Gel for Injection to Improve Temple Hollowing in Chinese Adults
CONDITIONS
Official Title
A Prospective, Multicenter, Randomized, No-treatment Controlled, Assessor-blinded, Superiority Clinical Trial to Evaluate the Efficacy and Safety of Polycaprolactone Gel for Injection to Improve Temple Hollowing in Chinese Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 65 years old (inclusive), male or female
- Willing to receive temple filling treatment
- Have flat to severe temple hollowing on both sides with scores between 1 and 4 and a difference of at most 2 between sides
- Able to self-assess treatment efficacy without glasses or while wearing contact lenses
- Voluntarily sign informed consent and agree to comply with all study requirements including treatments and follow-ups
You will not qualify if you...
- Known allergies to polycaprolactone, carboxymethylcellulose, glycerin, or any product ingredients
- History of severe allergies or multiple severe allergic reactions
- Abnormal blood clotting or recent use of blood thinners within 2 weeks prior to enrollment
- Temple hollowing caused by trauma, congenital defects, or lipodystrophy
- Previous or current temporal arteritis
- Temporomandibular disorders or other jaw diseases
- Recurrent temporal headaches such as tendonitis or migraine
- Previous injections of certain fillers or treatments in the temple area within specified timeframes
- Facial surgeries affecting the temples
- Presence of tattoos, piercings, significant facial hair, scars, wounds, skin diseases, infections, cancers, or precancerous lesions above the subnasale
- Active autoimmune diseases, infections, or porphyria
- Tendency to form keloids or other healing disorders
- Recent chemotherapy, immunosuppressants, or systemic corticosteroids within 3 months
- Severe dysfunction of vital organs or uncontrolled chronic diseases
- Planned cosmetic procedures above the subnasale during the study
- Recent or planned dental or facial surgeries affecting upper facial contour
- Planned significant weight change (≥10%) during the study
- Participation in other clinical trials within 3 months
- Pregnancy or lactation
- Women planning pregnancy or not using effective contraception, and men unwilling to use contraception
- Any condition deemed inappropriate for participation by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Peking University First Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
M
Meng Yan
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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