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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06054646
Enrollment
20
Registered
2023-09-26
Start date
2019-05-01
Completion date
2021-12-08
Last updated
2023-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Facial Wrinkles - Rough Texture - Hyperpigmentation

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.

Interventions

BIOLOGICALAmnion collagen

A collagen extract sourced from the human amniotic membrane

BIOLOGICALPlatelet-rich plasma

Autologous preparation of PRP

Sponsors

Waleed Nemr,Egyptian Atomic Energy Authority
CollaboratorUNKNOWN
Egyptian Atomic Energy Authority
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
FEMALE
Age
36 Years to 57 Years
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

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

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of facial wrinkles according to wrinkle severity rate scale (WSRS)2 weeksgrade 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.
Evaluation of facial wrinkles according to Global Aesthetic Improvement Scale (GAIS)2 weeksNo improvement or mild improvement less than 25% moderate improvement = 26%-50% marked improvement = 51%-75% excellent improvement = more than 75%
skin pigmentation assessed by skin hyper-pigmentation index2 weeksscore: No pigmentation=1, sever pigmentation=4
Histopathology improvement of skin biopsy2 weeksimproved skin structure=1, non-improved skin structure=0

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026