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Evaluating the safety and effectiveness of injectable gel with the W&O XtraIII brand

Evaluating the safety and effectiveness of injectable gel with the W&O XtraIII brand, for correcting nasolabial folds, before and after single clinical trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190210042676N30
Enrollment
30
Registered
2023-10-08
Start date
2023-10-07
Completion date
Unknown
Last updated
2023-10-16

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 W&O XtraIII injectable gel in each nasolabial fold. W&O XtraIII is a sterile physiological solution, without fever microbial agent. The active ingredient

Sponsors

Ara Teb Gostar Soroush 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 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: 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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

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