TCTR20260718006Active, not recruitingPhase 4
A Prospective Study of the Efficacy and Safety of Polycaprolactone (PCL) Collagen Stimulator in Facial Rejuvenation and Contouring
Rungsima Wanitphakdeedecha0 sites30 target enrollmentStarted: July 1, 2026Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 4
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 30
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 30 Years to 60 Years (—)
- Sex
- All
Inclusion Criteria
- •moderate-severe photoaging
- •mild-moderate facial laxity
Exclusion Criteria
- •Pregnant or breastfeeding women
- •patients with history of platelet disorders, coagulation abnormalities, anemia, liver disease, cancer, or autoimmune disorders.
- •Patients who smoke or have a history of excessive alcohol consumption (defined as a smoking history of more than 20 pack-years and alcohol consumption exceeding 15 standard drinks per week for men or 8 standard drinks per week for women).
- •Patients with facial dermatitis, wounds, or skin infections at the treatment site.
- •Patients with a history of allergy to local anesthetic agents.
- •Patients who currently taking medications that affect blood coagulation, such as aspirin or anticoagulants.
- •Individuals who have undergone laser treatment, radiofrequency treatment, thread lifting, or other facial tightening procedures within 6 months prior to study enrollment.
- •Individuals who have undergone facial chemical peeling within 6 months prior to study enrollment.
- •Individuals who have received botulinum toxin injections to the face within 6 months prior to study enrollment.
- •Patients who have received dermal filler injections or platelet-rich plasma (PRP) injections to the face within 6 months prior to study enrollment.
- •Patients with a history of hypertrophic scar or keloid formation.
- •Patients with psychiatric disorders previously diagnosed by a psychiatrist.
Arms & Interventions
Patients will be treated with 2.4 mL of PCL filler administered at 10 predetermined injection points on the face. Follow-up visits will be scheduled at 1, 3, 6, 9, and 12 months after treatment.;Experimental Drug;PCL filler
Intervention: Patients will be treated with 2.4 mL of PCL filler administered at 10 predetermined injection points on the face. Follow-up visits will be scheduled at 1, 3, 6, 9, and 12 months after treatment.;Experimental Drug;PCL filler
Investigators
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