CTRI/2024/04/066000
Recruiting
Phase 4
Efficacy and safety of monophasic versus biphasic hyaluronic acid dermal fillers in correction of moderate-to-severe nasolabial folds: A randomized, controlled, double blinded and intraindividual study - NI
Punjab government dental college and hospital Amritsar0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: - Health Condition 2: L00-L99- Diseases of the skin and subcutaneous tissue
- Sponsor
- Punjab government dental college and hospital Amritsar
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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