Stromal Vascular Fraction Enriched PRP in Treatment of Post-acne Scars

July 24, 2024 updated by: Mona El Radi Kamal Mohamed Emam, Zagazig University

Split Face Comparative Study of Stromal Vascular Fraction Enriched PRP Versus Each Alone in Treatment of Atrophic Post-acne Scars

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Zagazig, Egypt
        • Zagazig university hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SVF enriched PRP vs PRP
Biological: Stromal vascular fraction (SVF) enriched platelet rich plasma (PRP) versus each alone
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.
Active Comparator: SVF enriched PRP vs SVF
Biological: Stromal vascular fraction (SVF) enriched platelet rich plasma (PRP) versus each alone
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.
Active Comparator: PRP vs SVF
Biological: Stromal vascular fraction (SVF) enriched platelet rich plasma (PRP) versus each alone
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in severity of acne scars using Goodman scoring system
Time Frame: 3 monthly sessions and follow up for 3 months after the last visit
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zagazig University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

October 6, 2023

First Submitted That Met QC Criteria

July 24, 2024

First Posted (Actual)

July 29, 2024

Study Record Updates

Last Update Posted (Actual)

July 29, 2024

Last Update Submitted That Met QC Criteria

July 24, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dr. MonaRadi

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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