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Safety and effectiveness assessment of Fiorage L. gel for nasolabial folds correction

Safety and effectiveness assessment of Fiorage L. gel produced by Orchid Pharmed company for nasolabial folds correction

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20150101020514N12
Enrollment
30
Registered
2021-06-29
Start date
2021-07-23
Completion date
Unknown
Last updated
2021-07-12

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 Fiorage L injectable gel in each nasolabial fold. The product is 1cc prefilled sterilized syringe containing: Hyaluronic Acid gel, 24 mg Lidocaine hydroch

Sponsors

Zist orchid pharmed Company
Lead Sponsor

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 based onAllergan criteria The opportunity to accompany the visit programs and study process. Signing the infirmed consent form and agree to a 6-month follow-up

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

Design outcomes

Primary

MeasureTime 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 photonumeric grading.

Secondary

MeasureTime 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 4, 2026