Skip to content

Clinical evaluation of safety and effectiveness of Nuxiwell for tear trough or inferaorbital hollows.

Clinical evaluation of safety and effectiveness of Nuxiwell for tear trough or inferaorbital hollows, made by Amitis Nik Darou Company

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190210042676N43
Enrollment
20
Registered
2025-06-02
Start date
2025-06-22
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 Nuxiwell filler made by Amitis Nik Darou Company injectable gel in each Infraorbital Hollows. Nuxiwell is two 1ml syringe containing 16 mg of hyaluronic

Sponsors

Amitis Nik Darou Company
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 Any inflammation, active infection, old wound that has not healed, and skin lesions in Infraorbital Hollows Using oral collagen and HA supplements

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: ???? ??? ?? ??????? ?? ??? ??? ??????? ? ?? ???? ????? ????? 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).;Pigmentation intensity(E factor) and skin lightness(L factor) of Infraorbital Hollows. Timepoint: Before intervention, 2 weeks, 3 and 6 months after intervention. Method of measurement: Visioface camera.

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