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Investigating and safety and effectiveness of engineered microneedle patches containing concentrated medium conditioning derived from foreskin fibroblast cells in removing darkness and wrinkles around the eyes in a human

Investigating and safety and effectiveness of engineered microneedle patches containing concentrated medium conditioning derived from foreskin fibroblast cells in removing darkness and wrinkles around the eyes in a human (Randomized Controlled Interventional a split-face Study)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20221130056672N10
Enrollment
30
Registered
2025-04-27
Start date
2025-09-23
Completion date
Unknown
Last updated
2025-07-21

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: Intervention group: 30 patients who will receive a patch injection on one side of their face along with the selected medium condition group. Intervention 2: Control group: The same 30

Sponsors

Skin and Stem Cell Research Center, University of Tehran
Lead Sponsor
Tehran University of Medical Sciences
Collaborator

Eligibility

Sex/Gender
All
Age
35 Years to 55 Years

Inclusion criteria

Inclusion criteria: Having the desired age range Full patient consent to participate in the project Not taking oral collagen Absence of active inflammatory acne on the skin Absence of local infections at the treatment site The skin at the treatment site is not prone to keloids. The patient does not have malignancy. The patient is not pregnant or breastfeeding. Not having blood clotting diseases or platelet disorders and not taking medications that affect bleeding and blood clotting mechanisms. No immune suppression Not using topical or systemic steroids Absence of systemic diseases such as high blood pressure, diabetes, cardiovascular disease, kidney disease, liver disease, etc. Not using exfoliants for four weeks prior to entering the plan. Avoid Botox injections on the face due to toxin release. No history of major surgery within the past six months. Absence of other acute infections on the face such as herpes (Herpes labialis) and folliculitis ??? ????? ?? ?????? ??? ???? ?????? ????? ?????? ? HIV

Exclusion criteria

Exclusion criteria: Lack of consent to continue treatment for any reason Failure to follow up with the patient Known sensitivity to components of the microneedle patch Severe allergic reaction to treatment Positive sensitivity test to conditioned medium

Design outcomes

Primary

MeasureTime frame
The amount of skin wrinkles. Timepoint: Beginning and end of the intervention, two months after the intervention. Method of measurement: Visio Face device.;Skin elasticity and flexibility. Timepoint: Beginning and end of the intervention, two months after the intervention. Method of measurement: Cutometer device.;Skin moisture level. Timepoint: Beginning and end of the intervention, two months after the intervention. Method of measurement: Corneometer device.;The level of transparency, brightness and skin color. Timepoint: Beginning and end of the intervention, two months after the intervention. Method of measurement: Colorimeter device.;Skin thickness and density. Timepoint: Beginning and end of the intervention, two months after the intervention. Method of measurement: Sonography device.

Secondary

MeasureTime frame
The safety and efficacy of treatment. Timepoint: Beginning and end of the intervention, two months after the intervention. Method of measurement: Patient's medical report, form of treatment satisfaction and recovery status that is filled out by the patient. Results from the patient's biometric analysis.

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