Atrophic ScarNCT07569666
Exososmes in Atrophic Scars Management
A study testing Intralesional exosomes and Intralesional Saline in people with Atrophic Scar, run by Zagazig University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrophic Scar
- What is being tested?
- Intralesional exosomes and Intralesional Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2025to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Zagazig University Hospitals
Zagazig, Zagazig, 44519
mona Elradi, +201067070550, monaelradi@medicine.zu.edu.eg
About this study
Official title: 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.
Read more
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.
- Conditions
- Atrophic Scar
- Being tested
- Intralesional exosomes, Intralesional Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intralesional exosomesOther
exosomes are injected within the substance of the scar.
Intralesional SalineOther
all patients will receive both, exosomes and saline, each injected into one scar.
| Study group | Role | What they receive |
|---|---|---|
| Exosomes | Active comparator | Not described Receives: Other: Intralesional exosomes |
| Saline | Placebo comparator | Not described Receives: Other: Intralesional Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months after 4 biweekly sessions
Secondary 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
Measured: 3 months after 4 biweekly sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start15 Jun 2025
- Primary completionNov 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrophic ScarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07569666
- Sponsor's protocol ID
- 1125/2-3-2025
- Status last verified
- Mar 2026
- First submitted
- 25 Apr 2026
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Intralesional Exosomes Versus Intralesional Saline in The Treatment of Atrophic Scars: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07569666
- Acronym / sponsor ID
- 1125/2-3-2025
- Conditions
- Atrophic Scar
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 15 Jun 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exosomes | Active comparator | Other: Intralesional exosomes |
| Saline | Placebo comparator | Other: Intralesional Saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intralesional exosomesexosomes are injected within the substance of the scar. | Other | Exosomes |
| Intralesional Salineall patients will receive both, exosomes and saline, each injected into one scar. | Other | Saline |
Primary outcome
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
1 secondary outcome
Scar thickness measurement in millimetres by Ultrasound examination
Time frame: 3 months after 4 biweekly sessions
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intralesional exosomes and Intralesional Saline in people with Atrophic Scar, run by Zagazig University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact mona Elradi (+201067070550, monaelradi@medicine.zu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified Manchester Scar Scale (time frame: 3 months after 4 biweekly sessions). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.