Clinical trial

Evaluation of Microinjected Amnion-derived Collagen by Dermapen in the Smoothing of Skin Wrinkles

Name
3122019NCRRT
Description
The aim of this work was to assess the efficacy of irradiated amniotic collagen matrix in comparison with platelet rich plasma in facial rejuvenation.The present study included 20 patients with facial wrinkles divided into 2 groups using split face technique: Group (A) subjected to microneedling with amnion gel on the right side of the face . Group (B) subjected to microneedling with PRP on the other side of the face.According to a skin analysis camera (antera camera), there was statistically significant improvement after treatment and between both groups as regard to the roughness(texture) and melanin appeared by Antera camera in which group (A) showed better improvement than group (B). Also, skin biopsies showed improvement in both sides after treatment in which the epidermis was thicker, collagen bundles were broader and thicker than before treatment also elastic fibers were longer, evenly arranged and thicker than before treatment. The patients were followed up over a period of 3 months after the last session with no complications or changes were occurred and the results of sessions were maintained.
Trial arms
Trial start
2019-05-01
Estimated PCD
2021-09-22
Trial end
2021-12-08
Status
Completed
Phase
Early phase I
Treatment
Amnion collagen
A collagen extract sourced from the human amniotic membrane
Arms:
Amnion Collagen
Platelet-rich plasma
Autologous preparation of PRP
Arms:
PRP
Other names:
PRP
Size
20
Primary endpoint
Evaluation of facial wrinkles according to wrinkle severity rate scale (WSRS)
2 weeks
Evaluation of facial wrinkles according to Global Aesthetic Improvement Scale (GAIS)
2 weeks
skin pigmentation assessed by skin hyper-pigmentation index
2 weeks
Histopathology improvement of skin biopsy
2 weeks
Eligibility criteria
Inclusion Criteria: * Patients who did not receive any treatment for aging within the last 6 months. * Patients who accepted to participate in this study. Exclusion Criteria: * Patients with bleeding, coagulation disorders, severe anemia, liver disease, renal disease, recurrent facial herpes, keloid formation, pregnant, and lactating females.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}}, 'enrollmentInfo': {'count': 20, 'type': 'ACTUAL'}}
Updated at
2023-10-04

1 organization

2 products

1 indication

Indication
Facial Wrinkles