Skip to main content
OpenTrials
Completed

NCT Number: NCT06054646

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Facial Wrinkles - Rough Texture - Hyperpigmentation

Age range

36 year–57 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Egyptain Atomic Energy Authority

Cairo, 29, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Amnion collagen

Biological

A collagen extract sourced from the human amniotic membrane

Platelet-Rich Plasma

Biological

Autologous preparation of PRP

Other names: PRP

Primary outcomes

  1. Evaluation of facial wrinkles according to wrinkle severity rate scale (WSRS)

    Time frame: 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.

  2. Evaluation of facial wrinkles according to Global Aesthetic Improvement Scale (GAIS)

    Time frame: 2 weeks

    No improvement or mild improvement less than 25% moderate improvement = 26%-50% marked improvement = 51%-75% excellent improvement = more than 75%

  3. skin pigmentation assessed by skin hyper-pigmentation index

    Time frame: 2 weeks

    score: No pigmentation=1, sever pigmentation=4

  4. Histopathology improvement of skin biopsy

    Time frame: 2 weeks

    improved skin structure=1, non-improved skin structure=0

Sponsors and collaborators

Lead sponsor

Egyptian Atomic Energy Authority

Other Gov

Collaborators

  • Waleed Nemr,Egyptian Atomic Energy Authority

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 26, 2023
Registry last updated
Oct 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.