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

NCT ID: NCT06054646

Last Updated: 2023-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2021-12-08

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.

Detailed Description

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Conditions

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Facial Wrinkles - Rough Texture - Hyperpigmentation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Amnion Collagen

The right side of the split-face was treated by micro-injection of Amnion Collagen

Group Type ACTIVE_COMPARATOR

Amnion collagen

Intervention Type BIOLOGICAL

A collagen extract sourced from the human amniotic membrane

PRP

The left side of the split-face was treated by micro-injection of Platelet-rich plasma (PRP)

Group Type ACTIVE_COMPARATOR

Platelet-rich plasma

Intervention Type BIOLOGICAL

Autologous preparation of PRP

Interventions

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Amnion collagen

A collagen extract sourced from the human amniotic membrane

Intervention Type BIOLOGICAL

Platelet-rich plasma

Autologous preparation of PRP

Intervention Type BIOLOGICAL

Other Intervention Names

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PRP

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.
Minimum Eligible Age

36 Years

Maximum Eligible Age

57 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Waleed Nemr,Egyptian Atomic Energy Authority

UNKNOWN

Sponsor Role collaborator

Egyptian Atomic Energy Authority

OTHER_GOV

Sponsor Role lead

Responsible Party

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Nashwa Radwan

Head of amnion preparation laboratory

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Egyptain Atomic Energy Authority

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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3122019NCRRT

Identifier Type: -

Identifier Source: org_study_id

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