Efficacy and safety of non-cross-linked hyaluronic acid containing exosomes derived from fibroblast cells foreskin in rejuvenating the skin around the eyes in humans

Efficacy and safety of non-cross-linked hyaluronic acid containing exosomes derived from fibroblast cells foreskin in rejuvenating the skin around the eyes in humans (clinical trial phase 1 & 2)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20221130056672N5

Enrollment

Registered

2024-01-29

Start date

2024-03-25

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 rejuvenation.

Interventions

Intervention 1: Group a: treated with non-cross-linked hyaluronic acid combination (0.5 cc) along with exosomes derived from fibroblast foreskin at a dose of 50 micrograms. Intervention 2: Group b: Tr

Eligibility

Sex/Gender

All

Age

35 Years to 45 Years

Inclusion criteria

Inclusion criteria: The age of these people to enter the study is between 35 and 45 years old. The skin around the eyes (crow's feet area) of patients has lost its original properties and started to wrinkle.

Exclusion criteria

Exclusion criteria: Allergy to injections and syringes People who participate in this study should not have used rejuvenation methods such as Botox 4 to 6 months before the start of the study and injections. Hypersensitivity to non-crosslinked hyaluronic acid

Design outcomes

Primary

Measure	Time frame
Rejuvenation of crow's feet skin around the eyes. Timepoint: Changes in the mentioned area are measured 4 weeks, 8 weeks, and 12 weeks after the injection, and 8 weeks after the last injection (20 weeks from the day of injection), final examinations are performed. Method of measurement: 1- Visio face: a full-face photography method for facial skin analysis, optimal product recommendation and treatment documentation. Using this method, before and after the skin and the surface and depth of wrinkles are measured. 2- Colorimeter: The colorimeter contains a photocell that is able to detect the amount of light passing through the investigated solution. As a result, the color is checked before and after the end of the test so that a diagnosis can be made in case of lightening of the skin. 4- Sonography: This test is also used to measure thickness and density.	—

Measure

Time frame

Rejuvenation of crow's feet skin around the eyes. Timepoint: Changes in the mentioned area are measured 4 weeks, 8 weeks, and 12 weeks after the injection, and 8 weeks after the last injection (20 weeks from the day of injection), final examinations are performed. Method of measurement: 1- Visio face: a full-face photography method for facial skin analysis, optimal product recommendation and treatment documentation. Using this method, before and after the skin and the surface and depth of wrinkles are measured. 2- Colorimeter: The colorimeter contains a photocell that is able to detect the amount of light passing through the investigated solution. As a result, the color is checked before and after the end of the test so that a diagnosis can be made in case of lightening of the skin. 4- Sonography: This test is also used to measure thickness and density.

—

Secondary

Measure	Time frame
Safety. Timepoint: Checks for safety are done one week after each injection and before the time of re-injection. Method of measurement: Patient history and lack of swelling in the injection area.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactEhsan Taghiabadi

Tehran University of Medical Sciences

etaghiabadi@sina.tums.ac.ir+98 21 2665 7438

Outcome results

None listed

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