Safety and effectiveness of Lunafill Ultra intradermal injectable gel for correcting nasolabial folds

Safety and effectiveness assessment of Lunafill Ultra intradermal injectable gel containing hyaluronic acid ( 24mg/ml) and lidocaine 0.3% for correcting nasolabial folds. Phase II, before after clinical study

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20150101020514N11

Enrollment

Registered

2021-03-17

Start date

2021-04-05

Completion date

Unknown

Last updated

2021-04-26

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

Conditions

Skin aging.

Interventions

Intervention group: one injection with 1-2 cc Lunafill ultra intradermal injectable gel in each nasolabial fold. The product is 1cc prefilled sterilized syringe containing: Hyaluronic Acid gel, 24 mg

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 18 -65 years old men and women Moderate to severe nasolabial folds Signing the infirmed consent form

Exclusion criteria

Exclusion criteria: Previous hyaluronic acid (HA)-based dermal filler treatment(s) injected within the last 12 months prior to enrollment Cosmetic facial procedures (chemical peel, laser, radio frequency, dermabrasion, ablative or non-ablative procedures), Botox) in the lower 2/3 of the face, within 3 month prior to study entry Planning to undergo any of these procedures at any time during the study Allergy or sensitivity to lidocaine, hyaluronic acid products Active inflammation, infection, cancerous or pre-cancerous lesion or unhealed wound in the NLF region Current treatment with anti-coagulation therapy or use of non-steroidal anti-inflammatory drugs or other substances known to increase coagulation time within 10 days of undergoing study injections People prone to hypertrophic scar formation History of ant auto immune or immune deficiency diseases or using any immune suppressive drug Pregnancy and breast feeding

Design outcomes

Primary

Measure	Time frame
Severity of nasolabial folds. Timepoint: Before intervention and right after that and 2 weeks, 3 and 6 months later. Method of measurement: 5 scale Allergan phot numeric grading.	—

Secondary

Measure	Time frame
Depth, area and volume of nasolabial fold. Timepoint: Before intervention and right after that and 2 weeks, 3 and 6 months later. Method of measurement: Visioface camera.;Thickness and density of dermis. Timepoint: Before intervention and 2 weeks and 6 months later. Method of measurement: Skin ultrasound.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAniseh Samadi

Tehran University of Medical Sciences

dermalab@tums.ac.ir+98 21 8897 2220

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026