NCT07775092

Brief Summary

This study compares the efficacy and safety of poly-L-lactic acid (PLLA) threads versus platelet-rich plasma (PRP), both combined with subcision, in the treatment of post-traumatic atrophic scars. Patients with post-traumatic atrophic scars were allocated to either a single session of subcision followed by PLLA thread insertion or four monthly sessions of subcision combined with PRP injection. Clinical improvement, patient satisfaction, adverse effects, and histopathological changes were assessed during a 3-month follow-up period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

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 6, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 21, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

August 15, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 20, 2026

Completed
Last Updated

August 20, 2026

Status Verified

August 1, 2026

Enrollment Period

7 months

First QC Date

August 15, 2026

Last Update Submit

August 15, 2026

Conditions

Keywords

acne scarsPRPsubscisionthreads

Outcome Measures

Primary Outcomes (1)

  • Global Aesthetic Improvement Scale (GAIS) score

    Clinical improvement of post-traumatic atrophic scars was assessed using the Global Aesthetic Improvement Scale by two dermatologists blinded to the treatment group. The scale was graded from 1 to 4: Grade 1 = mild/no improvement (0-25%), Grade 2 = moderate improvement (26-50%), Grade 3 = marked improvement (51-75%), and Grade 4 = excellent improvement (\>75%).

    3 months after treatment

Study Arms (2)

subcision and PLLA threads

ACTIVE COMPARATOR

subcision and PLLA threads' insertion at the same session

Procedure: subcision and PLLA threads' insertion

PRP and subcision (PRP-S) injection

ACTIVE COMPARATOR

PRP and subcision (PRP-S) injection monthly for four sessions

Procedure: PRP and subcision (PRP-S)

Interventions

subcision and PLLA threads' insertion at the same session

subcision and PLLA threads

PRP and subcision (PRP-S) injection monthly for four sessions

PRP and subcision (PRP-S) injection

Eligibility Criteria

Age16 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients with post-traumatic atrophic scars. Scar duration of at least 1 year. No treatment received during the previous 6 months.

You may not qualify if:

  • Keloids Immunosuppression Coagulative disorders Thrombophilic disorders Any chronic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University Hospitals

Tanta, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

August 15, 2026

First Posted

August 20, 2026

Study Start

February 6, 2023

Primary Completion

August 21, 2023

Study Completion

August 31, 2024

Last Updated

August 20, 2026

Record last verified: 2026-08

Locations