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

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ClinicalTrials.gov Identifier: NCT06054646
Recruitment Status : Completed
First Posted : September 26, 2023
Last Update Posted : October 4, 2023
Sponsor:
Collaborator:
Waleed Nemr,Egyptian Atomic Energy Authority
Information provided by (Responsible Party):
Nashwa Radwan, Egyptian Atomic Energy Authority

Study Description
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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.

Condition or disease Intervention/treatment Phase
Facial Wrinkles - Rough Texture - Hyperpigmentation Biological: Amnion collagen Biological: Platelet-rich plasma Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of Microinjected Amnion-derived Collagen by Dermapen in the Smoothing of Skin Wrinkles
Actual Study Start Date : May 1, 2019
Actual Primary Completion Date : September 22, 2021
Actual Study Completion Date : December 8, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Collagen

Arms and Interventions
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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 Name: PRP


Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   36 Years to 57 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Because females are interested in facial rejuvenation more than males. So, this study targeted females.
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06054646


Locations
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Egypt
Egyptain Atomic Energy Authority
Cairo, Egypt, 29
Sponsors and Collaborators
Egyptian Atomic Energy Authority
Waleed Nemr,Egyptian Atomic Energy Authority
More Information
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Responsible Party: Nashwa Radwan, Head of amnion preparation laboratory, Egyptian Atomic Energy Authority
ClinicalTrials.gov Identifier: NCT06054646    
Other Study ID Numbers: 3122019NCRRT
First Posted: September 26, 2023    Key Record Dates
Last Update Posted: October 4, 2023
Last Verified: October 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hyperpigmentation
Pigmentation Disorders
Skin Diseases