Exososmes in Atrophic Scars Management

May 1, 2026 updated by: Zagazig University

Evaluation of Intralesional Exosomes Versus Intralesional Saline in The Treatment of Atrophic Scars: A Randomized Controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Zagazig
      • Zagazig, Zagazig, Egypt, 44519

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Saline
Other: Intralesional Saline
all patients will receive both, exosomes and saline, each injected into one scar.
Active Comparator: Exosomes
Other: Intralesional exosomes
exosomes are injected within the substance of the scar.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
modified Manchester Scar Scale
Time Frame: 3 months after 4 biweekly sessions
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Scar thickness measurement in millimetres by Ultrasound examination
Time Frame: 3 months after 4 biweekly sessions
Scar characteristics, including scar thickness and echogenicity, will be assessed using high-frequency ultrasound examination. Scar thickness will be measured in millimeters, and changes from baseline to follow-up will be summarized. Higher scar thickness values indicate greater scar tissue thickness
3 months after 4 biweekly sessions

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zagazig University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

April 25, 2026

First Submitted That Met QC Criteria

May 1, 2026

First Posted (Actual)

May 6, 2026

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

May 1, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 1125/2-3-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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