Tear Trough Eyelid DeformityPhase 1NCT06318091
Nanofat Versus Platelet Poor Plasma Gel for Infraorbital Rejuvenation
A Phase 1 study testing platelet poor plasma gel and nanofat in people with Tear Trough Eyelid Deformity, run by Mansoura University at 1 site in Egypt.
Trial summary
this study was conducted for evaluation of the clinical efficacy, safety, and potential side effects of platelet poor plasma gel versus nonfat injection in infraorbital rejuvenation Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tear Trough Eyelid Deformity
- What is being tested?
- platelet poor plasma gel and nanofat
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2021to 1 Jun 2023
- Phase
- Phase 1
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- all patients with infraorbital dark circles
Who cannot join
- pregnancy
- breast feeding
- infectious disorders
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Manousra University, Faculty of Medicine
Al Mansurah, Dakahlia Governorate, 35511
About this study
this study was conducted for evaluation of the clinical efficacy, safety, and potential side effects of platelet poor plasma gel versus nonfat injection in infraorbital rejuvenation
- Conditions
- Tear Trough Eyelid Deformity
- Being tested
- platelet poor plasma gel, nanofat
- Keywords
- platelet poor plasma gel, nanofat, infraorbital rejuvenation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
platelet poor plasma gelBiological
injection of platelet poor plasma gel in the dark circles around the eye to rejuvenate and improve pigmentation
nanofatBiological
injection of nanofat in the dark circles around the eye to rejuvenate and improve pigmentation
| Study group | Role | What they receive |
|---|---|---|
| platelet poor plasma gel group | Active comparator | in this group, plasma gel will be injected intradermally in the dark circles. Receives: Biological: platelet poor plasma gel |
| nanofat group | Active comparator | in this group, nanofat will be injected intradermally and subcutaneously in the dark circles Receives: Biological: nanofat |
What is being measured
The primary outcome is the main question the study is designed to answer.
the degree of changes in the skin texture and homogeneity
the degree of changes in the skin texture and homogeneity was assessed using the five grades scale according to percentage of change in skin surface smoothness and color uniformity (1: much worse if deterioration >25%, 2: worse if deterioration <25%, 3: slightly improved if improvement <25%, 4: improved if improvement = 25%-50%, and 5: greatly improved if improvement >50%).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start1 Jun 2021
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tear Trough Eyelid DeformityStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06318091
- Sponsor's protocol ID
- MS.21.09.1640
- Status last verified
- Mar 2024
- First submitted
- 5 Mar 2024
- Last updated
- 19 Mar 2024
- 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 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nanofat Versus Platelet Poor Plasma Gel for Infraorbital Rejuvenation
- ClinicalTrials.gov ID
- NCT06318091
- Acronym / sponsor ID
- MS.21.09.1640
- Conditions
- Tear Trough Eyelid Deformity
- Keywords
- platelet poor plasma gel, nanofat, infraorbital rejuvenation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 19 Mar 2024 (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.
this study was conducted for evaluation of the clinical efficacy, safety, and potential side effects of platelet poor plasma gel versus nonfat injection in infraorbital rejuvenation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| platelet poor plasma gel group | Active comparator | Biological: platelet poor plasma gelin this group, plasma gel will be injected intradermally in the dark circles. |
| nanofat group | Active comparator | Biological: nanofatin this group, nanofat will be injected intradermally and subcutaneously in the dark circles |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- all patients with infraorbital dark circles
Key exclusion criteria (3 listed)
- pregnancy
- breast feeding
- infectious disorders
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 |
|---|---|---|
| platelet poor plasma gelinjection of platelet poor plasma gel in the dark circles around the eye to rejuvenate and improve pigmentation | Biological | platelet poor plasma gel group |
| nanofatinjection of nanofat in the dark circles around the eye to rejuvenate and improve pigmentation | Biological | nanofat group |
Primary outcome
the degree of changes in the skin texture and homogeneity
Time frame: 3 months
the degree of changes in the skin texture and homogeneity was assessed using the five grades scale according to percentage of change in skin surface smoothness and color uniformity (1: much worse if deterioration >25%, 2: worse if deterioration <25%, 3: slightly improved if improvement <25%, 4: improved if improvement = 25%-50%, and 5: greatly improved if improvement >50%).
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 19 Mar 2024.
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 1 study testing platelet poor plasma gel and nanofat in people with Tear Trough Eyelid Deformity, run by Mansoura University 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 1 inclusion and 3 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 19 Mar 2024. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
the degree of changes in the skin texture and homogeneity (time frame: 3 months). 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 19 Mar 2024.