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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

From the registry’s dates

  • Registered 4 years 4 months after the study started (first participant enrolled May 2019, registered Sep 2023).
Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
36 Years to 57 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 12 studies in Hyperpigmentation with a site in Egypt — 4 open to participants now, 5 under way, 1 of them phase 3. Hyperpigmentation · Egypt.

Enrollment
10th of 12
20 · median 30
Started
2019
with 2 others
Phase 2
Only one
of the 12
Registered
5th of 12
by date
Lead sponsor
1 of 12
Egyptian Atomic Energy Authority

Among the 12 studies in Hyperpigmentation with a site in Egypt, this one is the 10th largest by enrollment, is one of 3 that started in 2019, is the only one in phase 2, and was the 5th registered.

By phase

12 studies; the count open now beside each. This study's row is marked.

No phase9 · 3 open
Phase 1/21 · 0 open
Phase 2this study1 · 0 open
Phase 31 · 1 open

By the year they started

First in 2019; this study’s year is marked. 3 started in 2019.

Size and results

Median enrollment 30 across the 12 interventional studies. Of the 6 that completed or were terminated, 0 (0%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 12 studies in Hyperpigmentation with a site in Egypt, or all of them as a file.
02

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.

03

Conditions studied

  • Facial Wrinkles - Rough Texture - Hyperpigmentation

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04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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.
05

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

  • Autologous preparation of PRP

    Also known as: PRP

06

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

07

Study locations

1 site
  • Egyptain Atomic Energy Authority
    Cairo, 29, Egypt
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2019 to primary completion in Sep 2021, 28 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 19, 2023
First posted
Sep 26, 2023
StartActual
May 1, 2019
Primary completionActual
Sep 22, 2021
CompletionActual
Dec 8, 2021
Last update
Oct 4, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 4, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

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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This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Platelet rich plasma

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