NCT06318091

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2021

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 19, 2024

Completed
Last Updated

March 19, 2024

Status Verified

March 1, 2024

Enrollment Period

2 years

First QC Date

March 5, 2024

Last Update Submit

March 12, 2024

Conditions

Tear Trough Eyelid Deformity

Keywords

platelet poor plasma gelnanofatinfraorbital rejuvenation

Outcome Measures

Primary Outcomes (1)

  • 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%).

    3 months

Study Arms (2)

platelet poor plasma gel group

ACTIVE COMPARATOR

in this group, plasma gel will be injected intradermally in the dark circles.

Biological: platelet poor plasma gel

nanofat group

ACTIVE COMPARATOR

in this group, nanofat will be injected intradermally and subcutaneously in the dark circles

Biological: nanofat

Interventions

platelet poor plasma gelBIOLOGICAL

injection of platelet poor plasma gel in the dark circles around the eye to rejuvenate and improve pigmentation

platelet poor plasma gel group
nanofatBIOLOGICAL

injection of nanofat in the dark circles around the eye to rejuvenate and improve pigmentation

nanofat group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • all patients with infraorbital dark circles

You may not qualify if:

  • pregnancy
  • breast feeding
  • infectious disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manousra University, Faculty of Medicine

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2024

First Posted

March 19, 2024

Study Start

June 1, 2021

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

March 19, 2024

Record last verified: 2024-03

Locations

EG(1)