Efficacy and safety of hyaluronic acid dermal fillers in correction of moderate to severe smile lines

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 - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/04/066000

Enrollment

Registered

2024-04-19

Start date

Unknown

Completion date

Unknown

Last updated

2025-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: - Health Condition 2: L00-L99- Diseases of the skin and subcutaneous tissue

Interventions

Intervention1: Hyaluronic acid dermal filler: Random injection of Monophasic hyaluronic acid dermal filler at one side nasolabial fold and biphasic hyaluronic acid dermal filler at other remaining nas

Eligibility

Inclusion 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

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 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 whoâ??ll not give consent for the procedure.

Design outcomes

Primary

Measure	Time frame
To assess the efficacy using Wrinkle Severity Rating Scale (WSRS). To evaluate the aesthetic improvement using Global Aesthetic Improvement Scale (GAIS). To evaluate patient reported outcome measure (PROM) assessing subject satisfaction using an Ad hoc 5- grade structured scale. To evaluate pain at injection site using Visual Analog Scale (VAS). To evaluate any other findings/events during the study.Timepoint: Patient will be followed up at interval at 12, 24, 36 weeks	—

Measure

Time frame

To assess the efficacy using Wrinkle Severity Rating Scale (WSRS). To evaluate the aesthetic improvement using Global Aesthetic Improvement Scale (GAIS). To evaluate patient reported outcome measure (PROM) assessing subject satisfaction using an Ad hoc 5- grade structured scale. To evaluate pain at injection site using Visual Analog Scale (VAS). To evaluate any other findings/events during the study.Timepoint: Patient will be followed up at interval at 12, 24, 36 weeks

—

Secondary

Measure	Time frame
To evaluate any other findings/events during the study.Timepoint: 36 weeks	—

Countries

India

Contacts

Public ContactDr Nitin Verma

Punjab Government Dental college and Hospital

nitinvermagdc@gmail.com9814164068

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026