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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exosomes | Active Comparator |
| |
| Saline | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intralesional exosomes | Other | exosomes are injected within the substance of the scar. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 months after 4 biweekly sessions |
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Inclusion Criteria:
Age >18 years
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| mona Elradi | Contact | +201067070550 | monaelradi@medicine.zu.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zagazig University Hospitals | Recruiting | Zagazig | Zagazig | 44519 | Egypt |
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| Intralesional Saline |
| Other |
all patients will receive both, exosomes and saline, each injected into one scar. |
|