Exososmes in Atrophic Scars Management
Evaluation of Intralesional Exosomes Versus Intralesional Saline in The Treatment of Atrophic Scars: A Randomized Controlled Trial
1 other identifier
interventional
12
1 country
1
Brief Summary
Lay Summary (Simple Explanation) Atrophic scars are depressed scars that form when the skin does not heal properly, commonly seen after acne or injuries. These scars can affect appearance and confidence, and current treatments may not always give satisfactory results. This study aims to evaluate a new treatment using exosomes, which are tiny particles naturally released by cells that help in skin repair and regeneration. Researchers will compare the effect of injecting exosomes directly into scars versus injecting a simple saltwater solution (saline), which serves as a control. Participants will be randomly assigned to receive either exosome injections or saline injections. Neither the patient nor the evaluator may know which treatment is given, to ensure fair comparison. The goal is to determine whether exosomes can safely and effectively improve the appearance and texture of atrophic scars.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 15, 2025
CompletedFirst Submitted
Initial submission to the registry
April 25, 2026
CompletedFirst Posted
Study publicly available on registry
May 6, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2027
May 6, 2026
March 1, 2026
1.4 years
April 25, 2026
May 1, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
modified Manchester Scar Scale
Scar appearance was assessed using the Modified Manchester Scar Scale. The Modified Manchester Scar Scale ranges from 4 to 24, with lower scores indicating better scar appearance and higher scores indicating worse scar appearance
3 months after 4 biweekly sessions
Secondary Outcomes (1)
Scar thickness measurement in millimetres by Ultrasound examination
3 months after 4 biweekly sessions
Study Arms (2)
Exosomes
ACTIVE COMPARATORSaline
PLACEBO COMPARATORInterventions
all patients will receive both, exosomes and saline, each injected into one scar.
Eligibility Criteria
You may qualify if:
- Age \>18 years
- Either gender
- Scars of any duration
- Multiple scars at one side or both sides of the face.
- Patients are willing to sign written informed consent statements before beginning treatment.
You may not qualify if:
- Pregnant females.
- Patients with one scar.
- Hypersensitivity to any of the used treatments.
- Patient with infection at the site of the scar.
- Patients with unrealistic expectations.
- Patient refusing to sign on the consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zagazig University Hospitals
Zagazig, Zagazig, 44519, Egypt
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 25, 2026
First Posted
May 6, 2026
Study Start
June 15, 2025
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
February 1, 2027
Last Updated
May 6, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share