hydrogel effectiveness in the treatment of skin wrinkles

Phase 1

Recruiting

• Conditions: skin wrinkles.; Other specified disorders of the skin and subcutaneous tissue; L98.8

• Registration Number: IRCT20210612051545N2
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 November 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).