NCT07561671

Brief 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. 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 2, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 1, 2026

Completed
Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

1.6 years

First QC Date

April 25, 2026

Last Update Submit

April 25, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • INA score (Change in striae severity)

    baseline to 1 month after last session

  • Change in striae severity (INA score)

    1 month after last session

Study Arms (4)

PRF

ACTIVE COMPARATOR

Intradermal injection of platelet-rich fibrin

Biological: PRF group

PRF +Microneedling

ACTIVE COMPARATOR

Microneedling followed by topical PRF application

Device: PRF+ microneedling

PRP

ACTIVE COMPARATOR

Intradermal injection of platelet-rich plasma

Biological: PRP injection

PRP+microneedling

ACTIVE COMPARATOR
Device: PRP +microneedling

Interventions

PRF groupBIOLOGICAL

Autologous platelet-rich fibrin prepared via single-spin centrifugation without anticoagulant and injected intradermally

PRF
PRP injectionBIOLOGICAL

Intradermal injection of platelet-rich plasma

PRP

Performed using a dermapen device with 1 mm needle depth, followed by topical application of PRF.

PRF +Microneedling

Performed using a dermapen device with 1 mm needle depth, followed by topical application of PRP.

PRP+microneedling

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults ≥18 years Presence of striae distensae (rubrae or alba) Willingness to participate and provide informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zagazig University Hospitals

Zagazig, Zagazig--, 44519, Egypt

Location

MeSH Terms

Conditions

Striae Distensae

Condition Hierarchy (Ancestors)

Skin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

April 25, 2026

First Posted

May 1, 2026

Study Start

February 2, 2024

Primary Completion

September 25, 2025

Study Completion

February 17, 2026

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations