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

Study Overview
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Brief Summary
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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.

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

Conditions
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Facial Wrinkles - Rough Texture - Hyperpigmentation

Intervention / Treatment
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* Biological: Amnion collagen
* Biological: Platelet-rich plasma


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 36 Years
Maximum Age: 57 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Amnion Collagen<br>The right side of the split-face was treated by micro-injection of Amnion Collagen | Biological: Amnion collagen<br>* A collagen extract sourced from the human amniotic membrane<br>|
| Active Comparator: PRP<br>The left side of the split-face was treated by micro-injection of Platelet-rich plasma (PRP) | Biological: Platelet-rich plasma<br>* Autologous preparation of PRP<br>* Other names: PRP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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% | 2 weeks | 
| skin pigmentation assessed by skin hyper-pigmentation index | score: No pigmentation=1, sever pigmentation=4 | 2 weeks | 
| Histopathology improvement of skin biopsy | improved skin structure=1, non-improved skin structure=0 | 2 weeks |