Facial Wrinkles - Rough Texture - HyperpigmentationPhase 2NCT06054646
Evaluation of Microinjected Amnion-derived Collagen by Dermapen in the Smoothing of Skin Wrinkles
A Phase 2 study testing Amnion collagen and Platelet-rich plasma in people with Facial Wrinkles - Rough Texture - Hyperpigmentation, run by Egyptian Atomic Energy Authority at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 36 to 57 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Facial Wrinkles - Rough Texture - Hyperpigmentation
- What is being tested?
- Amnion collagen and Platelet-rich plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2019to 8 Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 36 to 57 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients who did not receive any treatment for aging within the last 6 months.
- Patients who accepted to participate in this study.
Who cannot join
- Patients with bleeding, coagulation disorders, severe anemia, liver disease, renal disease, recurrent facial herpes, keloid formation, pregnant, and lactating females.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Amnion collagen, Platelet-rich plasma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amnion collagenBiological
A collagen extract sourced from the human amniotic membrane
Platelet-rich plasmaBiological
Also called PRP
Autologous preparation of PRP
| Study group | Role | What they receive |
|---|---|---|
| Amnion Collagen | Active comparator | The right side of the split-face was treated by micro-injection of Amnion Collagen Receives: Biological: Amnion collagen |
| PRP | Active comparator | The left side of the split-face was treated by micro-injection of Platelet-rich plasma (PRP) Receives: Biological: Platelet-rich plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks
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%
Measured: 2 weeks
skin pigmentation assessed by skin hyper-pigmentation index
score: No pigmentation=1, sever pigmentation=4
Measured: 2 weeks
Histopathology improvement of skin biopsy
improved skin structure=1, non-improved skin structure=0
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start1 May 2019
- Primary completion22 Sep 2021
- Study completion8 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial Wrinkles - Rough Texture - HyperpigmentationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Egyptian Atomic Energy Authority
- Sponsor type
- Other government
- Collaborators
- Waleed Nemr,Egyptian Atomic Energy Authority
- Responsible party
- Principal investigator, Nashwa Radwan, Egyptian Atomic Energy Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06054646
- Sponsor's protocol ID
- 3122019NCRRT
- Status last verified
- Oct 2023
- First submitted
- 19 Sep 2023
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Microinjected Amnion-derived Collagen by Dermapen in the Smoothing of Skin Wrinkles
- ClinicalTrials.gov ID
- NCT06054646
- Acronym / sponsor ID
- 3122019NCRRT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Egyptian Atomic Energy AuthorityOther government
- Collaborators
- Waleed Nemr,Egyptian Atomic Energy Authority
- Study start
- 1 May 2019 (actual)
- Primary completion
- 22 Sep 2021 (actual)
- Study completion
- 8 Dec 2021 (actual)
- First posted
- 26 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amnion Collagen | Active comparator | Biological: Amnion collagenThe right side of the split-face was treated by micro-injection of Amnion Collagen |
| PRP | Active comparator | Biological: Platelet-rich plasmaThe left side of the split-face was treated by micro-injection of Platelet-rich plasma (PRP) |
Who may qualify
- Ages
- 36 to 57 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients who did not receive any treatment for aging within the last 6 months.
- Patients who accepted to participate in this study.
Key exclusion criteria (1 listed)
- Patients with bleeding, coagulation disorders, severe anemia, liver disease, renal disease, recurrent facial herpes, keloid formation, pregnant, and lactating females.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amnion collagenA collagen extract sourced from the human amniotic membrane | Biological | Amnion Collagen |
| Platelet-rich plasmaAlso: PRPAutologous preparation of PRP | Biological | PRP |
Primary outcome
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.
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%
skin pigmentation assessed by skin hyper-pigmentation index
Time frame: 2 weeks
score: No pigmentation=1, sever pigmentation=4
Histopathology improvement of skin biopsy
Time frame: 2 weeks
improved skin structure=1, non-improved skin structure=0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Amnion collagen and Platelet-rich plasma in people with Facial Wrinkles - Rough Texture - Hyperpigmentation, run by Egyptian Atomic Energy Authority at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of facial wrinkles according to wrinkle severity rate scale (WSRS) (time frame: 2 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2023.