Health Condition 1: null- Nasolabial fold correction
Conditions
Interventions
Intervention1: Hyfil 0.5 ml: Hyfil 0.5 ml
Intervention2: Hyfil 1.0 ml: Hyfil 1.0 ml
Control Intervention1: Nil: Nil
Sponsors
Dr Hemanth Nandigala Executive Director Comm
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female, at least 18 years of age; 2. Signs a written informed consent; 3. Understands and accepts the obligation not to receive any other procedures in the dorsum of the hands for 1 month; 4. Understands and accepts the obligation and is logistically able to be present for all scheduled follow-up visits.
Exclusion criteria
Exclusion criteria: 1. Pregnant and lactating women; 2. Has had any dermal fillers or surgery in the dorsum of the hand; 3. Subjects with allergic reaction to the study product.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in erythema, edema and pain from baseline to 24, 48, 72 hrs, 7th day and 30th day during post-therapy ? visual assessment by investigator.Timepoint: Baseline,24,48,72 hrs,7th day and 30th day. | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events and local injection site reactions.Timepoint: Baseline,24,48,72 hrs,7th day and 30th day. | — |
Countries
India
Contacts
Public ContactDr TC Raghuram
Director
Outcome results
None listed