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Safety and efficacy assessment of injectable gel with Perleux® brand, in order to rejuvenate facial skin

Safety and efficacy assessment of injectable gel containing stabilized hyaluronic acid with Perleux® brand, in order to rejuvenate and improve facial skin elasticity and hydration

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20150101020514N17
Enrollment
20
Registered
2022-12-06
Start date
2022-12-22
Completion date
Unknown
Last updated
2023-02-07

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

Conditions

Skin Hydration.

Interventions

Intervention group: One injection with 2 ccstabilized hyaluronic acid with Perleux® brand. The product is 2cc prefilled sterilized syringe containing: 32 mg Hyaluronic Acid with high molecular weight+

Sponsors

Zist orchid pharmed Company
Lead Sponsor

Eligibility

Sex/Gender
All
Age
35 Years to 60 Years

Inclusion criteria

Inclusion criteria: 35 -60 years old men and women The presence of visible signs of skin aging mainly dry skin, skin roughness, loss of elasticity and clear lines and wrinkles. Have signed 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 History of radiofrequency (R-F), rejuvenation lasers or intense pulsed light in the past 6 months Pregnancy or lactation

Design outcomes

Primary

MeasureTime frame
Skin elasticity (R0, R2, R5) measured in right cheek. Timepoint: Before intervention, 8 and 16 weeks later. Method of measurement: By cutometer probe of MPA 580(Multi Probe Adaptor) device.

Secondary

MeasureTime frame
Thickness and density of dermis. Timepoint: Before intervention, 8 and 16 weeks later. Method of measurement: Skin ultrasound.;Trans Epidermal Water Lost (TEWL) measured in right cheek. Timepoint: Before intervention, 8 and 16 weeks later. Method of measurement: By TEWA probe of MPA 580(Multi Probe Adaptor) device.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAniseh Samadi

Tehran University of Medical Sciences

dermalab@tums.ac.ir+98 21 8897 2220

Outcome results

None listed

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