Clinical study to evaluate the safety and efficacy of Intella dermal filler for correction of nasolabial folds

A single-arm, before- after clinical study to evaluate the safety and efficacy of Intella dermal filler (produced by Espad Pharmed Darou Co.) for correction of moderate to severe nasolabial folds

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20150101020514N27

Enrollment

Registered

2024-01-24

Start date

2024-01-21

Completion date

Unknown

Last updated

2024-03-06

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 ml Intella brand gel produced by Espad Pharmed company in each nasolabial folds. Intella is a pyrogen-free, viscous, opaque, injectable, semi-solid, latex-f

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 18-65 year old men and women Moderate to severe nasolabial folds based on Allergan 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: History of type 1 allergic reactions or anaphylaxis reaction Previous hyaluronic acid-based dermal filler injected within the last 12 months prior to enrollment. History of hypertrophic and keloid scars or bleeding disorders in the nasolabial region Active inflammatory processes, infection, lesions (cancerous/non-cancerous) in the nasolabial region History of autoimmune diseases/immune deficiency or use of immunosuppressive medicines during the 6 months before entering the study or during the study Pregnancy or lactation

Design outcomes

Primary

Measure	Time frame
Severity of nasolabial folds. Timepoint: Before intervention and right after intervention and 2, 4, 12 and 24 weeks later. Method of measurement: 5 scale Allergan photo numeric grading.	—

Secondary

Measure	Time frame
Number of people with at least one grade of reduction in the severity of both nasolabial folds. Timepoint: Before intervention and 3 and 6 months later. Method of measurement: scale Allergan photo numeric grading.;Depth, area and volume of nasolabial fold. Timepoint: Before intervention ,1 ,3 and 6 months later. Method of measurement: Visioface camera.;Thickness and density of dermis. Timepoint: Before intervention ,1 and 6 months later. Method of measurement: Skin ultrasound.	—

Measure

Time frame

Number of people with at least one grade of reduction in the severity of both nasolabial folds. Timepoint: Before intervention and 3 and 6 months later. Method of measurement: scale Allergan photo numeric grading.;Depth, area and volume of nasolabial fold. Timepoint: Before intervention ,1 ,3 and 6 months later. Method of measurement: Visioface camera.;Thickness and density of dermis. Timepoint: Before intervention ,1 and 6 months later. Method of measurement: Skin ultrasound.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactAniseh Samadi

Tehran University of Medical Sciences

aniseh_samadi@yahoo.com+98 21 8896 0880

Outcome results

None listed

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