NCT06054646

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2021

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 19, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 26, 2023

Completed
Last Updated

October 4, 2023

Status Verified

October 1, 2023

Enrollment Period

2.4 years

First QC Date

September 19, 2023

Last Update Submit

October 2, 2023

Conditions

Facial Wrinkles - Rough Texture - Hyperpigmentation

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (2)

Amnion Collagen

ACTIVE COMPARATOR

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

Biological: Amnion collagen

PRP

ACTIVE COMPARATOR

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

Biological: Platelet-rich plasma

Interventions

Amnion collagenBIOLOGICAL

A collagen extract sourced from the human amniotic membrane

Amnion Collagen
Platelet-rich plasmaBIOLOGICAL

Autologous preparation of PRP

Also known as: PRP
PRP

Eligibility Criteria

Age36 Years - 57 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsBecause females are interested in facial rejuvenation more than males. So, this study targeted females.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients who did not receive any treatment for aging within the last 6 months.
  • Patients who accepted to participate in this study.

You may not qualify if:

  • Patients with bleeding, coagulation disorders, severe anemia, liver disease, renal disease, recurrent facial herpes, keloid formation, pregnant, and lactating females.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Egyptain Atomic Energy Authority

Cairo, 29, Egypt

Location

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of amnion preparation laboratory

Study Record Dates

First Submitted

September 19, 2023

First Posted

September 26, 2023

Study Start

May 1, 2019

Primary Completion

September 22, 2021

Study Completion

December 8, 2021

Last Updated

October 4, 2023

Record last verified: 2023-10

Locations

EG(1)