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CompletedNCT06054646Updated Oct 4, 2023

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

A Phase 2 interventional study of Amnion collagen and Platelet-rich plasma in Facial Wrinkles - Rough Texture - Hyperpigmentation, sponsored by Egyptian Atomic Energy Authority. Completed at 1 site in Egypt. Open to female participants aged 36 Years to 57 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-04.

Sponsored by Egyptian Atomic Energy Authority · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
36 Years to 57 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Facial Wrinkles - Rough Texture - Hyperpigmentation

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03

Who can participate

Ages eligible
36 Years to 57 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Patients with bleeding, coagulation disorders, severe anemia, liver disease, renal disease, recurrent facial herpes, keloid formation, pregnant, and lactating females.
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
20 participants (actual)

Study arms

  • Active comparator
    Amnion Collagen

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

    Biological: Amnion collagen

  • Active comparator
    PRP

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

    Biological: Platelet-rich plasma

Interventions

  • BiologicalAmnion collagen

    A collagen extract sourced from the human amniotic membrane

  • BiologicalPlatelet-rich plasma

    Autologous preparation of PRP

    Also known as: PRP

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2 weeks

  2. 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%

    Time frame: 2 weeks

  3. skin pigmentation assessed by skin hyper-pigmentation index

    score: No pigmentation=1, sever pigmentation=4

    Time frame: 2 weeks

  4. Histopathology improvement of skin biopsy

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

    Time frame: 2 weeks

06

Study locations

1 site
  • Egyptain Atomic Energy Authority
    Cairo, 29, Egypt
07

Registry details

Key details

Study ID
NCT06054646
Lead sponsor
Egyptian Atomic Energy Authority
Collaborators
Waleed Nemr,Egyptian Atomic Energy Authority
Responsible party
Nashwa Radwan (Head of amnion preparation laboratory, Egyptian Atomic Energy Authority) — Principal investigator
First posted
Sep 26, 2023
Start date
May 1, 2019
Primary completion
Sep 22, 2021
Completion
Dec 8, 2021
Last update
Oct 4, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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