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

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.

Study Overview

• Status: Completed
• Conditions: Facial Wrinkles - Rough Texture - Hyperpigmentation
• Intervention / Treatment: Biological: Amnion collagen; Biological: Platelet-rich plasma

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 29
    • Egyptain Atomic Energy Authority

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient's satisfaction	All patient were asked about their satisfaction at the final visit The range of this measure: very satisfied, satisfied, slightly satisfied or not satisfied	2 weeks

Collaborators and Investigators

• Sponsor: Egyptian Atomic Energy Authority
• Collaborators: Waleed Nemr,Egyptian Atomic Energy Authority

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Actual): September 22, 2021
• Study Completion (Actual): December 8, 2021

Study Registration Dates

• First Submitted: September 19, 2023
• First Submitted That Met QC Criteria: September 19, 2023
• First Posted (Actual): September 26, 2023

Study Record Updates

• Last Update Posted (Actual): October 4, 2023
• Last Update Submitted That Met QC Criteria: October 2, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Hyperpigmentation
• Other Study ID Numbers: 3122019NCRRT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No