Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202510463370770 Date of Registration: 08/10/2025
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Evaluation Of The Effect Of Synthetic Exosomes On Periorbital Rejuvenation: A Single-Arm Clinical Trial
Official scientific title Evaluation Of The Effect Of Synthetic Exosomes On Periorbital Rejuvenation: A Single-Arm Clinical Trial
Brief summary describing the background and objectives of the trial Background and Rationale: The eyes are the aesthetic centerpiece of the face. As prominent facial features, the periorbital area is one of the first regions to reveal signs of aging and plays an important role in overall facial appearance. Aging skin is characterized by the appearance of fine and coarse wrinkles, rough and uneven texture, dryness, skin laxity and changes in pigmentation. ( Glaser et al, 2010) While aging is inevitable, its visible manifestations can be delayed or minimized. Regenerative medicine is a developing field focused on the repair, rejuvenation, replacement, or regeneration of tissues and organs to reestablish normal function ( Jafarzadeh et al., 2024) There is growing interest in therapies based on biological mechanisms of intercellular communication, which can modulate the inflammatory response, stimulate collagen synthesis, and promote skin repair. In this context, extracellular vesicles (EVs) playing a crucial role in cell-to-cell signaling deserve special attention. (Buzas et al,2023) (Sun et al,2024) Exosomes can be used as a delivery system for drugs, proteins, mRNA, miRNA, IncRNA, and small molecules to recipient cells, which can regulate macrophages, fibroblasts, vascular endothelial cells, and myofibroblast functions in wounds to promote healing (Bunggulawa et al., 2018). Exosomes are involved in regulating the proliferation of epidermal cells, fibroblasts, restoring the ECM components, lowering ROS levels and ultimately reversing skin aging. ( Wu et al.,2022 ) Objectives: To evaluate the efficacy of synthetic exosomes in the rejuvenation of periorbital region by assessing the improvement of skin texture, elasticity, dyschromia and wrinkle reduction.
Type of trial Non-Randomised
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Wrinkles, fine lines, dyschromia around eyes
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 15/10/2025
Actual trial start date
Anticipated date of last follow up 31/05/2026
Actual Last follow-up date
Anticipated target sample size (number of participants) 36
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Single Group Non-randomised Allocation Sequence/Code was not concealed Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Synthetic Exosomes Injection of 2 mL of solution per session, composed of 1 mL synthetic exosomes mixed with 1 mL of 0.9% sodium chloride (NaCI) solution. The mixture is equally distributed, with 1 mL administered to each periorbital area. 18 weeks duration Injection of 2 mL of solution per session, composed of 1 mL synthetic exosomes mixed with 1 mL of 0.9% sodium chloride (NaCI) solution. The mixture is equally distributed, with 1 mL administered to each periorbital area. One session every 2 weeks for 3 consecutive sessions. Patients are followed up at 2, 4, 6, and 18 weeks after the initial injection session. During each follow-up, assessments include serial standardized photography, evaluation using the Merz Periorbital Scale, and Global Aesthetic Improvement Scale (GAIS). 36
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Males and Females aged between 30 to 60 Presence of fine lines to moderate periorbital wrinkles Presence of dyschromias around eyes History of facial treatments (including topical agents ,laser therapy, chemical or organic peels, microneedling ,platelet-rich plasma (PRP) within past 2 months) History of botulinum toxin (Botox), dermal filler or Fat injections within the last 6 months Presence of infectious or autoimmune skin diseases Pregnant or lactating females Severe periorbital wrinkles Current or recent use (within 6 months) of oral vitamin A derivatives Diagnosed psychiatric disorders including dysmorphic disorder Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 30 Year(s) 60 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 14/08/2025 Research Ethics Committee Faculty of Medicine Cairo University
Ethics Committee Address
Street address City Postal code Country
Kasr Al Ainy street Kasr Al Ainy Hospital Cairo 3753450 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Evaluation of the efficacy of synthetic exosomes in the rejuvenation of periorbital region. One session every 2 weeks for 3 consecutive sessions. Patients are followed up at 2, 4, 6, and 18 weeks after the initial injection session.
Secondary Outcome Assessing the improvement of skin texture, elasticity, dyschromias and wrinkle reduction (Standarized photography, The Merz Scale and Global Aesthetic Improvement Scale) One session every 2 weeks for 3 consecutive sessions. Patients are followed up at 2, 4, 6, and 18 weeks after the initial injection session.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Plastic Surgery department Kasr Al Ainy Hospital Cairo University Kasr Al Ainy Street Cairo 3753450 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Kasr Al Ainy Hospital Kasr Al Ainy Hospital Cairo 3753450 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Plastic Surgery department Kasr Al Ainy Hospital Cairo University Kasr Al Ainy street Cairo 3753450 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed El Sayed dr_ahmedfathi2018@icloud.com 00201094768992 Kasr Al Ainy Street
City Postal code Country Position/Affiliation
Cairo 3753450 Egypt Lecturer of Plastic Surgery Kasr Al Ainy Hospital Cairo University
Role Name Email Phone Street address
Public Enquiries Nourihan Elhalawany nourhan.elhalawany1994@gmail.com 00201151834492 Kasr Al Ainy Street
City Postal code Country Position/Affiliation
Cairo 3753450 Egypt Plastic Surgery Resident Kasr Al Ainy Hospital Cairo University
Role Name Email Phone Street address
Scientific Enquiries Nourihan Elhalawany nourhan.elhalawany1994@gmail.com 00201151834492 Kasr Al Ainy Street
City Postal code Country Position/Affiliation
Cairo 3753450 Egypt Plastic Surgery Resident Kasr Al Ainy Hospital Cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after de-identification, will be made available to researchers upon reasonable request and subject to approval by the Research Ethics Committee. Informed Consent Form,Statistical Analysis Plan,Study Protocol Data will be available immediately following publication, with no end date for access. De-identified individual participant data will be available to qualified researchers upon submission of a reasonable request and a clear research proposal. Requests will be reviewed by the principal investigator in consultation with the Research Ethics Committee. Data will only be shared for academic, non-commercial purposes, and the intended analyses must be consistent with the objectives of the original study.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 03/10/2025 This is the email of ethics committee of Kasr Al Ainy , the previous email was sent by mistake TRUE, Research Ethics Committee Faculty of Medicine Cairo University , Kasr Al Ainy street Kasr Al Ainy Hospital , Cairo, 3753450, Egypt, , 14 Aug 2025, 00201003657120, nourhan.elhalawany1994@gmail.com, 37176_34367_4737.pdf TRUE, Research Ethics Committee Faculty of Medicine Cairo University , Kasr Al Ainy street Kasr Al Ainy Hospital , Cairo, 3753450, Egypt, , 14 Aug 2025, 00201003657120, kasralalinyrec@kasralainy.edu.eg, 37176_34367_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 03/10/2025 This is the email of ethics committee of Kasr Al Ainy , the previous email was sent by mistake TRUE, Research Ethics Committee Faculty of Medicine Cairo University , Kasr Al Ainy street Kasr Al Ainy Hospital , Cairo, 3753450, Egypt, , 14 Aug 2025, 00201003657120, kasralalinyrec@kasralainy.edu.eg, 37176_34367_4737.pdf TRUE, Research Ethics Committee Faculty of Medicine Cairo University , Kasr Al Ainy street Kasr Al Ainy Hospital , Cairo, 3753450, Egypt, , 14 Aug 2025, 00201003657120, kasralalinyrec@kasralainy.edu.eg, 37176_34367_4737.pdf