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Clinical evaluation of safety and effectiveness of injectable filler Lunagel fine Tear Trough

Clinical evaluation of safety and effectiveness of injectable filler Lunagel fine Tear Trough or Infraorbital Hollows

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190210042676N39
Enrollment
30
Registered
2025-01-28
Start date
2025-02-17
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Infraorbital Hollows. Changes in skin texture

Interventions

Intervention group: One injection with 0.5-1 cc Lunagel fine filler made by Nikan Teb Kimia CO injectable gel in each Infraorbital Hollows. Lunagel fine 1ml is a syringe containing 25 mg of hyaluronic

Sponsors

Nikan Teb Kimia CO
Lead Sponsor

Eligibility

Sex/Gender
All
Age
21 Years to 65 Years

Inclusion criteria

Inclusion criteria: 21 -65 years old men and women Infraorbital Hollows with grades 2, 3 and 4 (moderate, severe, and extreme) based on the allergen criteria The opportunity to accompany the visit programs and study process Signing the informed consent form and agree to a 6-month follow-up.

Exclusion criteria

Exclusion criteria: Previous hyaluronic acid (HA)-based filler treatment injected within the last year in upper areas of the face History of previous allergy to ingredients of gel or protein of gram-positive bacteria Using oral collagen and HA supplements Any inflammation, active infection, old wound that has not healed, and skin lesions in Infraorbital Hollows

Design outcomes

Primary

MeasureTime frame
Percentage of people with one grade or more improvement in Global Aesthetic Improvement Score (GAIS). Timepoint: Before intervention and 2 weeks after intervention. Method of measurement: Scoring by using digital photos based on Global Aesthetic Improvement Score (GAIS).

Secondary

MeasureTime frame
Percentage of people with one grade or more improvement in Global Aesthetic Improvement Score (GAIS). Timepoint: 3 and 6 months after the intervention. Method of measurement: Scoring by using digital photos based on Global Aesthetic Improvement Score (GAIS).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAniseh Samadi

Tehran University of Medical Sciences

aniseh_samadi@yahoo.com+98 21 8897 7921

Outcome results

None listed

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