Exososmes in Atrophic Scars Management
ConditionAtrophic Scar
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorZagazig University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Pregnant females.
Patients with one scar.
Hypersensitivity to any of the used treatments.
Patient with infection at the site of the scar.
Trial design
Design model
Parallel
Treatments tested in this trial
Intralesional exosomes
Other interventionexosomes are injected within the substance of the scar.
Intralesional Saline
Other interventionall patients will receive both, exosomes and saline, each injected into one scar.
Treatment groups
12 Participants
are divided into 2 treatment groupsGroup A: ExosomesActive comparator 1 intervention
Group B: SalinePlacebo comparator 1 intervention
Trial outcomes
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
Time frame
3 months after 4 biweekly sessionsSecondary outcomes
1
Scar thickness measurement in millimetres by Ultrasound examination
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
Time frame
3 months after 4 biweekly sessionsSponsors and contacts
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Source ClinicalTrials.gov