NCT06524011

Brief Summary

in a split face fashion, 30 patients will be randomized into 3 groups: Group A: rt side treated with SVF enriched PRP, lt side treated with prp Group B: rt side treated with SVF enriched PRP, lt side treated with SVF Group C: rt side treated with PRP, lt side treated with SVF

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2023

Completed
10 months until next milestone

First Posted

Study publicly available on registry

July 29, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

July 29, 2024

Status Verified

July 1, 2024

Enrollment Period

1 year

First QC Date

October 6, 2023

Last Update Submit

July 24, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • change in severity of acne scars using Goodman scoring system

    at baseline, acne scars will be assessed clinically using the 4 point grading system proposed by Goodman \&colleagues in 2006, patients' complaints and expectations will be addressed as well and the impact of acne scars on patients' quality of life will be investigated using the dermatology life quality index (DLQI). Goodman scoring system will be used at the last session and at the follow up visit to measure the change pre and post treatment.

    3 monthly sessions and follow up for 3 months after the last visit

Study Arms (3)

SVF enriched PRP vs PRP

EXPERIMENTAL
Biological: Stromal vascular fraction (SVF) enriched platelet rich plasma (PRP) versus each alone

SVF enriched PRP vs SVF

ACTIVE COMPARATOR
Biological: Stromal vascular fraction (SVF) enriched platelet rich plasma (PRP) versus each alone

PRP vs SVF

ACTIVE COMPARATOR
Biological: Stromal vascular fraction (SVF) enriched platelet rich plasma (PRP) versus each alone

Interventions

Adipose derived stromal vascular fraction cells will be aspirated and isolated from patient autologous adipose tissue and used to enrich patient's autologous platelet rich plasma then will be used to treat atrophic post acne scars versus each alone.

PRP vs SVFSVF enriched PRP vs PRPSVF enriched PRP vs SVF

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • patients with atrophic post acne scars without any previous treatment trials.
  • adequate blood picture, no anemia, no bleeding or platelet disorders.

You may not qualify if:

  • pregnant and lactating females.
  • elderly.
  • patients with bleeding tendencies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zagazig University Hospitals

Zagazig, 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 GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dermatology assistant professor

Study Record Dates

First Submitted

October 6, 2023

First Posted

July 29, 2024

Study Start

December 1, 2024

Primary Completion

December 1, 2025

Study Completion

February 1, 2026

Last Updated

July 29, 2024

Record last verified: 2024-07

Locations