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Clinical Trials/NCT07561671
NCT07561671
Completed
Not Applicable

Split-Side Comparative Clinical Study of Platelet-Rich Fibrin Versus Platelet-Rich Plasma With or Without Microneedling in Treatment of Striae Distensae

Zagazig University1 site in 1 country30 target enrollmentStarted: February 2, 2024Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
30
Locations
1
Primary Endpoint
INA score (Change in striae severity)

Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • 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

Arms & Interventions

PRF

Active Comparator

Intradermal injection of platelet-rich fibrin

Intervention: PRF group (Biological)

PRF +Microneedling

Active Comparator

Microneedling followed by topical PRF application

Intervention: PRF+ microneedling (Device)

PRP

Active Comparator

Intradermal injection of platelet-rich plasma

Intervention: PRP injection (Biological)

PRP+microneedling

Active Comparator

Intervention: PRP +microneedling (Device)

Outcomes

Primary Outcomes

INA score (Change in striae severity)

Time Frame: baseline to 1 month after last session

Change in striae severity (INA score)

Time Frame: 1 month after last session

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Mona El Radi Kamal Mohamed Emam

Dr

Zagazig University

Study Sites (1)

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