A Phase 2 interventional study of Amnion collagen and Platelet-rich plasma in Facial Wrinkles - Rough Texture - Hyperpigmentation, sponsored by Egyptian Atomic Energy Authority. Completed at 1 site in Egypt. Open to female participants aged 36 Years to 57 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-04.
Sponsored by Egyptian Atomic Energy Authority · Phase 2, Interventional, and Treatment
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.
Exclusion Criteria:
The right side of the split-face was treated by micro-injection of Amnion Collagen
Biological: Amnion collagen
The left side of the split-face was treated by micro-injection of Platelet-rich plasma (PRP)
Biological: Platelet-rich plasma
A collagen extract sourced from the human amniotic membrane
Autologous preparation of PRP
Also known as: PRP
Evaluation of facial wrinkles according to wrinkle severity rate scale (WSRS)
grade 0 = no wrinkles, grade I = just perceptible wrinkle, grade II = shallow wrinkles, grade III = moderately deep wrinkles, grade IV = deep wrinkle with well-defined edges, grade V = very deep wrinkle with redundant fold.
Time frame: 2 weeks
Evaluation of facial wrinkles according to Global Aesthetic Improvement Scale (GAIS)
No improvement or mild improvement less than 25% moderate improvement = 26%-50% marked improvement = 51%-75% excellent improvement = more than 75%
Time frame: 2 weeks
skin pigmentation assessed by skin hyper-pigmentation index
score: No pigmentation=1, sever pigmentation=4
Time frame: 2 weeks
Histopathology improvement of skin biopsy
improved skin structure=1, non-improved skin structure=0
Time frame: 2 weeks
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Egyptian Atomic Energy Authority