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NCT Number: NCT07569666

Exososmes in Atrophic Scars Management

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.

Recruiting

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Key information

Conditions

Atrophic Scar

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intralesional exosomes

Other

exosomes are injected within the substance of the scar.

Intralesional Saline

Other

all patients will receive both, exosomes and saline, each injected into one scar.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

mona Elradi

CONTACT

[email protected]

+201067070550

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
May 6, 2026
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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