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

Phase 2

Completed

• Conditions: Facial Wrinkles - Rough Texture - Hyperpigmentation
• Interventions: Biological: Amnion collagen; Biological: Platelet-rich plasma

• Registration Number: NCT06054646
• Lead Sponsor: Egyptian Atomic Energy Authority

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-01
• Primary Completion: 2021-09-22
• Study Completion: 2021-12-08
• Study First Submitted: 2023-09-19
• Study First Submitted QC: 2023-09-19
• Study First Posted: 2023-09-26
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-02
• Last Update Posted: 2023-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Amnion Collagen	Amnion collagen	The right side of the split-face was treated by micro-injection of Amnion Collagen
PRP	Platelet-rich plasma	The left side of the split-face was treated by micro-injection of Platelet-rich plasma (PRP)

Primary Outcome Measures

Name	Time	Method
Evaluation of facial wrinkles according to wrinkle severity rate scale (WSRS)	2 weeks	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.
skin pigmentation assessed by skin hyper-pigmentation index	2 weeks	score: No pigmentation=1, sever pigmentation=4
Evaluation of facial wrinkles according to Global Aesthetic Improvement Scale (GAIS)	2 weeks	No improvement or mild improvement less than 25% moderate improvement = 26%-50% marked improvement = 51%-75% excellent improvement = more than 75%
Histopathology improvement of skin biopsy	2 weeks	improved skin structure=1, non-improved skin structure=0

Trial Locations

Locations (1)

Egyptain Atomic Energy Authority; 🇪🇬 Cairo, Egypt