Evaluation of Microinjected Amnion-derived Collagen by Dermapen in the Smoothing of Skin Wrinkles
Primary Purpose
Facial Wrinkles - Rough Texture - Hyperpigmentation
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Amnion collagen
Platelet-rich plasma
Sponsored by
About this trial
This is an interventional treatment trial for Facial Wrinkles - Rough Texture - Hyperpigmentation
Eligibility 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.
Sites / Locations
- Egyptain Atomic Energy Authority
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Amnion Collagen
PRP
Arm Description
The right side of the split-face was treated by micro-injection of Amnion Collagen
The left side of the split-face was treated by micro-injection of Platelet-rich plasma (PRP)
Outcomes
Primary Outcome Measures
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.
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%
skin pigmentation assessed by skin hyper-pigmentation index
score: No pigmentation=1, sever pigmentation=4
Histopathology improvement of skin biopsy
improved skin structure=1, non-improved skin structure=0
Secondary Outcome Measures
Full Information
NCT ID
NCT06054646
First Posted
September 19, 2023
Last Updated
October 2, 2023
Sponsor
Egyptian Atomic Energy Authority
Collaborators
Waleed Nemr,Egyptian Atomic Energy Authority
1. Study Identification
Unique Protocol Identification Number
NCT06054646
Brief Title
Evaluation of Microinjected Amnion-derived Collagen by Dermapen in the Smoothing of Skin Wrinkles
Official Title
Evaluation of Microinjected Amnion-derived Collagen by Dermapen in the Smoothing of Skin Wrinkles
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
September 22, 2021 (Actual)
Study Completion Date
December 8, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Egyptian Atomic Energy Authority
Collaborators
Waleed Nemr,Egyptian Atomic Energy Authority
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Facial Wrinkles - Rough Texture - Hyperpigmentation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Amnion Collagen
Arm Type
Active Comparator
Arm Description
The right side of the split-face was treated by micro-injection of Amnion Collagen
Arm Title
PRP
Arm Type
Active Comparator
Arm Description
The left side of the split-face was treated by micro-injection of Platelet-rich plasma (PRP)
Intervention Type
Biological
Intervention Name(s)
Amnion collagen
Intervention Description
A collagen extract sourced from the human amniotic membrane
Intervention Type
Biological
Intervention Name(s)
Platelet-rich plasma
Other Intervention Name(s)
PRP
Intervention Description
Autologous preparation of PRP
Primary Outcome Measure Information:
Title
Evaluation of facial wrinkles according to wrinkle severity rate scale (WSRS)
Description
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
Title
Evaluation of facial wrinkles according to Global Aesthetic Improvement Scale (GAIS)
Description
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
Title
skin pigmentation assessed by skin hyper-pigmentation index
Description
score: No pigmentation=1, sever pigmentation=4
Time Frame
2 weeks
Title
Histopathology improvement of skin biopsy
Description
improved skin structure=1, non-improved skin structure=0
Time Frame
2 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Because females are interested in facial rejuvenation more than males. So, this study targeted females.
Minimum Age & Unit of Time
36 Years
Maximum Age & Unit of Time
57 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Egyptain Atomic Energy Authority
City
Cairo
ZIP/Postal Code
29
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Microinjected Amnion-derived Collagen by Dermapen in the Smoothing of Skin Wrinkles
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