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hydrogel effectiveness in the treatment of skin wrinkles

Evaluation the safety and efficacy of decellularized umbilical cord extracellular matrix (ECM) derived hydrogel in the treatment of skin wrinkles

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20210612051545N2
Enrollment
20
Registered
2022-09-10
Start date
2022-09-23
Completion date
Unknown
Last updated
2022-11-21

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

Conditions

skin wrinkles. Other specified disorders of the skin and subcutaneous tissue

Interventions

Intervention 1: Intervention group: local transplantation of hydrogel derived from decellularized extracellular matrix (ECM) of the umbilical cord was designed in 10 candidates with wrinkles. 3 times

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
35 Years to 65 Years

Inclusion criteria

Inclusion criteria: Wrinkle lines on the face should be in the range of 3-5 based on Wrinkle Severity Rating Scale

Exclusion criteria

Exclusion criteria: Suffering from uncontrolled chronic diseases including diabetes mellitus, underlying chronic liver, kidney and heart disease, chronic malnutrition, malignancy, coagulopathy or the use of anticoagulants, a history of autoimmune diseases and suffering from HBV, HIV, HCV viral infections Any cosmetic procedure such as fat injection within a year and permanent filler, microneedling, RF, laser and other cases within the last 6 months, except for using cream. Infection and any malignancy at the transplant recipient site Failure to receive cells in the treatment area during the past year Patients with vitiligo Moderate to severe chronic skin diseases such as eczema and psoriasis active acne People who have had systemic retinoid treatment (within the last 6 months) or topical retinoid treatment (within the last 2 weeks) History of keloid Women during pregnancy and breastfeeding Patients undergoing radiotherapy and chemotherapy

Design outcomes

Primary

MeasureTime frame
Absence of side effects, including short-term and long-term, systemic or local side effects, and severe or mild side effects in the treatment with hydrogel derived from decellularized umbilical cord ECM (zero and 2 weeks, 1, 2, 4 and 6 months after first injection) through clinical examination and CTCAE v5 review. Timepoint: (zero and 2 weeks, 1, 2, 4 and 6 months after first injection. Method of measurement: Wrinkle reduction based on WSRS score reduction six months after injection. Reduction of wrinkles based on the increase in GAIS score two weeks, 1, 4, and 6 months after the first injection).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAmir Bajouri

Tehran University of Medical Sciences

bajouri.md@gmail.com+98 21 2665 7541

Outcome results

None listed

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