Safety and effectiveness of injectable gel with the Perjunse brand

Phase 2

Recruiting

• Conditions: Skin aging.

• Registration Number: IRCT20150101020514N24
• Lead Sponsor: Pars Fardad Nano Technology Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

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

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 months prior to study entry
Planning to undergo any of these procedures at any time during the study
Any cosmetic facial procedures during last 3 months
Allergy to gram positive bacteria protein, gel ingredients
Auto immune or immune deficiency diseases
Pregnancy
Lactation

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Depth, area and volume of nasolabial fold. Timepoint: Before intervention and right after intervention and 2, 12 and 24 weeks later. Method of measurement: Visioface camera.;Thickness and density of dermis. Timepoint: Before intervention and right after intervention and 2, 12 and 24 weeks later. Method of measurement: Skin ultrasound.