Striae DistensaeNCT07561671
PRP vs PRF in Management of Striae Distensae
A study testing PRF group, PRP injection and PRF and microneedling in people with Striae Distensae, run by Zagazig University at 1 site in Egypt.
Trial summary
A split-side comparative clinical study evaluating the efficacy and safety of injectable platelet-rich fibrin (PRF) versus platelet-rich plasma (PRP), alone or combined with microneedling, in the treatment of striae distensae. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Striae Distensae
- What is being tested?
- PRF group, PRP injection and PRF and microneedling
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Feb 2024to 17 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥18 years
- Presence of striae distensae (rubrae or alba)
- Willingness to participate and provide informed consent
Who cannot join
- Keloid or hypertrophic scar tendency
- Bleeding disorders or anticoagulant use
- Pregnancy
- Active skin infections (e.g., herpes, impetigo, tinea)
- History of malignancy or collagen disease
- Use of antineoplastic drugs
- Conditions impairing wound healing
- Unrealistic expectations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Split-Side Comparative Clinical Study of Platelet-Rich Fibrin Versus Platelet-Rich Plasma With or Without Microneedling in Treatment of Striae Distensae
A split-side comparative clinical study evaluating the efficacy and safety of injectable platelet-rich fibrin (PRF) versus platelet-rich plasma (PRP), alone or combined with microneedling, in the treatment of striae distensae. Thirty patients received PRF or PRP on one side and combination therapy with microneedling on the contralateral side over five sessions. Outcomes included striae width, length, severity score, and patient satisfaction
- Conditions
- Striae Distensae
- Being tested
- PRF group, PRP injection, PRF and microneedling, PRP and microneedling
- Medical subject headings
- Striae Distensae
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRF groupBiological
Autologous platelet-rich fibrin prepared via single-spin centrifugation without anticoagulant and injected intradermally
PRP injectionBiological
Intradermal injection of platelet-rich plasma
PRF and microneedlingDevice
Performed using a dermapen device with 1 mm needle depth, followed by topical application of PRF.
PRP and microneedlingDevice
Performed using a dermapen device with 1 mm needle depth, followed by topical application of PRP.
| Study group | Role | What they receive |
|---|---|---|
| PRF | Active comparator | Intradermal injection of platelet-rich fibrin Receives: Biological: PRF group |
| PRF and Microneedling | Active comparator | Microneedling followed by topical PRF application Receives: Device: PRF and microneedling |
| PRP | Active comparator | Intradermal injection of platelet-rich plasma Receives: Biological: PRP injection |
| PRP and microneedling | Active comparator | Not described Receives: Device: PRP and microneedling |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Imam, Nelva, Alviera score (INA score) (Change in striae severity)
The INA score ranges from 0 to 54, with higher scores indicating greater striae distensae severity, therefore representing a worse outcome. Severity was categorized as mild for scores <21, moderate for scores 21-40, and severe for scores >40.
Measured: baseline to 1 month after last session
Change in striae severity (Imam, Nelva, Alviera score (INA score)
The INA score ranges from 0 to 54, with higher scores indicating greater striae distensae severity, therefore representing a worse outcome. Severity was categorized as mild for scores <21, moderate for scores 21-40, and severe for scores >40.
Measured: 1 month 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 posted1 May 2026
- Study start2 Feb 2024
- Primary completion25 Sep 2025
- Study completion17 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 Zagazig 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mona El Radi Kamal Mohamed Emam, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07561671
- Sponsor's protocol ID
- 11345-3-12-2023
- Status last verified
- Apr 2026
- First submitted
- 25 Apr 2026
- Last updated
- 7 May 2026
- Results posted
- 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 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Split-Side Comparative Clinical Study of Platelet-Rich Fibrin Versus Platelet-Rich Plasma With or Without Microneedling in Treatment of Striae Distensae
- ClinicalTrials.gov ID
- NCT07561671
- Acronym / sponsor ID
- 11345-3-12-2023
- Conditions
- Striae Distensae
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 2 Feb 2024 (actual)
- Primary completion
- 25 Sep 2025 (actual)
- Study completion
- 17 Feb 2026 (actual)
- First posted
- 1 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.
A split-side comparative clinical study evaluating the efficacy and safety of injectable platelet-rich fibrin (PRF) versus platelet-rich plasma (PRP), alone or combined with microneedling, in the treatment of striae distensae. Thirty patients received PRF or PRP on one side and combination therapy with microneedling on the contralateral side over five sessions. Outcomes included striae width, length, severity score, and patient satisfaction
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PRF | Active comparator | Biological: PRF groupIntradermal injection of platelet-rich fibrin |
| PRF and Microneedling | Active comparator | Device: PRF and microneedlingMicroneedling followed by topical PRF application |
| PRP | Active comparator | Biological: PRP injectionIntradermal injection of platelet-rich plasma |
| PRP and microneedling | Active comparator | Device: PRP and microneedling |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults ≥18 years
- Presence of striae distensae (rubrae or alba)
- Willingness to participate and provide informed consent
Key exclusion criteria (8 listed)
- Keloid or hypertrophic scar tendency
- Bleeding disorders or anticoagulant use
- Pregnancy
- Active skin infections (e.g., herpes, impetigo, tinea)
- History of malignancy or collagen disease
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 |
|---|---|---|
| PRF groupAutologous platelet-rich fibrin prepared via single-spin centrifugation without anticoagulant and injected intradermally | Biological | PRF |
| PRP injectionIntradermal injection of platelet-rich plasma | Biological | PRP |
| PRF and microneedlingPerformed using a dermapen device with 1 mm needle depth, followed by topical application of PRF. | Device | PRF and Microneedling |
| PRP and microneedlingPerformed using a dermapen device with 1 mm needle depth, followed by topical application of PRP. | Device | PRP and microneedling |
Primary outcome
The Imam, Nelva, Alviera score (INA score) (Change in striae severity)
Time frame: baseline to 1 month after last session
The INA score ranges from 0 to 54, with higher scores indicating greater striae distensae severity, therefore representing a worse outcome. Severity was categorized as mild for scores <21, moderate for scores 21-40, and severe for scores >40.
Change in striae severity (Imam, Nelva, Alviera score (INA score)
Time frame: 1 month after last session
The INA score ranges from 0 to 54, with higher scores indicating greater striae distensae severity, therefore representing a worse outcome. Severity was categorized as mild for scores <21, moderate for scores 21-40, and severe for scores >40.
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 7 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. 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 PRF group, PRP injection and PRF and microneedling in people with Striae Distensae, 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 3 inclusion and 8 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 7 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. 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?
The Imam, Nelva, Alviera score (INA score) (Change in striae severity) (time frame: baseline to 1 month after last session). The study lists 2 primary outcomes in all. 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 7 May 2026.