Striae DistensaeNCT07919964
Exosomes for Striae Distensae
A study testing Micro needling then exosome application topically and Micro needling in people with Striae Distensae, run by Tanta University at 1 site in Egypt.
Trial summary
This prospective comparative split-body study was carried out on 20 patients presenting with striae. All patients were subjected to full history taking, full general and dermatological examination, standared laboratory investigations, explanation of the procedure and possible side effects, patients signed a written… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Striae Distensae
- What is being tested?
- Micro needling then exosome application topically and Micro needling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients of both gender between 18\&50 years old clinically diagnosed with striae distensae. The distribution of striae was bilateral and almost symmetrical.
- Patients who did not receive any treatment for their striae distensae for at least one month before joining the study.
- Patients who accepted to be enrolled in the study and signed a written informed consen
Who cannot join
- Pregnant and lactating women. Patients with history of keloid scars. Patients with bleeding and coagulation disorders or receiving anticoagulants.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy and Safety of Exosomes in Treatment of Striae Distensae
This prospective comparative split-body study was carried out on 20 patients presenting with striae. All patients were subjected to full history taking, full general and dermatological examination, standared laboratory investigations, explanation of the procedure and possible side effects, patients signed a written informed consent. Digital photographs were taken before each session and monthly for 3 months after the end of treatment sessions. Each patient received three consecutive sessions two weeks apart.
Before the treatment sessions, patients were instructed to put topical anesthetic cream. During sessions, the treated areas were disinfected by alcohol 70%, microneedling was done on both sides with application of topical exosomes on the right side only. After sessions, a plastic wrap was put for one hour, patients were advised to put topical antibiotic twice daily for one week.
- Conditions
- Striae Distensae
- Being tested
- Micro needling then exosome application topically, Micro needling
- Medical subject headings
- Striae Distensae
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micro needling then exosome application topicallyProcedure or surgery
Three sessions
Micro needlingProcedure or surgery
Three sessions
| Study group | Role | What they receive |
|---|---|---|
| Micro needling followed by topical application of exosomes | Active comparator | Not described Receives: Procedure: Micro needling then exosome application topically |
| Micro needling | Active comparator | Not described Receives: Procedure: Micro needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quartile grading scale
Three binded dermatologists evaluated the photographs taken before treatment, one month after the last session and after the follow up period (3 months after the last session). Physicians assessed the results using quartile grading scale which categorizes the improvement as follows:
- Excellent improvement: greater than 75%. ii. Very good improvement: 50-74%. iii.Good improvement: 25-49%. iv. Mild or poor improvement: less than 25%.
Measured: Three months after last session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start1 Jan 2025
- Primary completion15 Dec 2025
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Striae DistensaeStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Ashraf Fouda, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07919964
- Sponsor's protocol ID
- 36264MS731/11/24
- Status last verified
- Oct 2026
- First submitted
- 31 Oct 2026
- Last updated
- 5 Nov 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 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of Exosomes in Treatment of Striae Distensae
- ClinicalTrials.gov ID
- NCT07919964
- Acronym / sponsor ID
- 36264MS731/11/24
- Conditions
- Striae Distensae
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 5 Nov 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.
This prospective comparative split-body study was carried out on 20 patients presenting with striae. All patients were subjected to full history taking, full general and dermatological examination, standared laboratory investigations, explanation of the procedure and possible side effects, patients signed a written informed consent. Digital photographs were taken before each session and monthly for 3 months after the end of treatment sessions. Each patient received three consecutive sessions two weeks apart.
Before the treatment sessions, patients were instructed to put topical anesthetic cream. During sessions, the treated areas were disinfected by alcohol 70%, microneedling was done on both sides with application of topical exosomes on the right side only. After sessions, a plastic wrap was put for one hour, patients were advised to put topical antibiotic twice daily for one week.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Micro needling followed by topical application of exosomes | Active comparator | Procedure: Micro needling then exosome application topically |
| Micro needling | Active comparator | Procedure: Micro needling |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients of both gender between 18\&50 years old clinically diagnosed with striae distensae. The distribution of striae was bilateral and almost symmetrical.
- Patients who did not receive any treatment for their striae distensae for at least one month before joining the study.
- Patients who accepted to be enrolled in the study and signed a written informed consen
Key exclusion criteria (1 listed)
- Pregnant and lactating women. Patients with history of keloid scars. Patients with bleeding and coagulation disorders or receiving anticoagulants.
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 |
|---|---|---|
| Micro needling then exosome application topicallyThree sessions | Procedure or surgery | Micro needling followed by topical application of exosomes |
| Micro needlingThree sessions | Procedure or surgery | Micro needling |
Primary outcome
Quartile grading scale
Time frame: Three months after last session
Three binded dermatologists evaluated the photographs taken before treatment, one month after the last session and after the follow up period (3 months after the last session). Physicians assessed the results using quartile grading scale which categorizes the improvement as follows: i. Excellent improvement: greater than 75%. ii. Very good improvement: 50-74%. iii.Good improvement: 25-49%. iv. Mild or poor improvement: less than 25%.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Micro needling then exosome application topically and Micro needling in people with Striae Distensae, run by Tanta 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 5 Nov 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quartile grading scale (time frame: Three months after last session). 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 5 Nov 2026.