Efficacy and safety of hyaluronic acid dermal fillers in correction of moderate to severe smile lines
- Conditions
- Health Condition 1: - Health Condition 2: L00-L99- Diseases of the skin and subcutaneous tissue
- Registration Number
- CTRI/2024/04/066000
- Lead Sponsor
- Punjab government dental college and hospital Amritsar
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Male or female, aged 25 years or older, with moderate-to-severe
symmetrical NLFs graded 3 (moderate) or 4 (severe) according to the 5-
grade Nasolabial Fold- Wrinkle Severity Rating Scale (NLF-WSRS).
Patients with healthy facial skin, free of disease or pathology in the area to
be treated.
Patients willing to abstain from any other facial, surgical or cosmetic
procedures in the treatment area for the duration of clinical study.
Patients with active skin disease, tumors, infection or related condition in or
near the area to be treated
Patients hypersensitive or allergic to hyaluronic acid, lidocaine or any amide
type of anesthetic.
Patients with corrective procedures performed or planned in nasolabial
region, such as silicone implants, permanent or semi-permanent fillers, laser
therapy, dermabrasion, botulinum toxin application, chemical peeling within
one year of the study.
Patients who are pregnant, lactating or on oral contraceptives.
Patients with tendency to hypertrophic scars, keloid formation, pigmentation
disorders, any autoimmune or connective tissue disorders.
Patients with diabetes mellitus, uncontrolled systemic diseases and on
antiplatelet, anticoagulant or thrombolytic medications.
Patients with mental disorders or emotional instability.
Patients who’ll not give consent for the procedure.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the efficacy using Wrinkle Severity Rating Scale (WSRS). <br/ ><br>To evaluate the aesthetic improvement using Global Aesthetic <br/ ><br>Improvement Scale (GAIS). <br/ ><br>To evaluate patient reported outcome measure (PROM) assessing <br/ ><br>subject satisfaction using an Ad hoc 5- grade structured scale. <br/ ><br> To evaluate pain at injection site using Visual Analog Scale (VAS). <br/ ><br> To evaluate any other findings/events during the study.Timepoint: Patient will be followed up at interval at 12, 24, 36 weeks
- Secondary Outcome Measures
Name Time Method To evaluate any other findings/events during the study.Timepoint: <br/ ><br>36 weeks