Efficacy of Stromal Vascular Fraction Versus Platelet Rich Plasma in Treatment of Androgenitic Alopecia

NCT06558565 | Not Yet Recruiting DMC

• 1 other identifier: MS-260-2023
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized controlled clinical trial is to test the efficacy \& safety of stromal vascular fraction in treatment of AGA \& compare it to PRP The main questions it aims to answer are:

• efficacy \& safety of SVF for treatment of AGA patients
• comparing it to PRP in treatment of AGA Participants will receive a single session of SVF in one half of the scalp \& a single session of PRP in the other half.

Conditions

Androgenetic Alopecia

Keywords

stromal vascular fraction - PRP- androgenetic alopecia

Outcome Measures

Primary Outcomes (1)

• comparison of SVF versus PRP

  to compare the mean difference in hair density,thickness, Norwood Hamilton scale, patient global assessment, patient satisfaction \& physician global assessment scores between SVF \& PRP.

  at 3 & 6 months after the sessions

Secondary Outcomes (1)

• Detecting efficacy of SVF in treatment of AGA

  at 3 & 6 months

Study Arms (2)

stromal vascular fraction side

ACTIVE COMPARATOR

stromal vascular fraction will be injected in one half of the frontal scalp

Procedure: stromal vascular fraction or platelet rich plasma

PRP side

ACTIVE COMPARATOR

PRP will be injected in the other half of frontal scalp

Procedure: stromal vascular fraction or platelet rich plasma

Interventions

stromal vascular fraction or platelet rich plasma PROCEDURE

stromal vascular fraction will be injected in one half of the scalp \& PRP will be injected in the other half

PRP side; stromal vascular fraction side

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years or older.
• Hamilton score I to VI in male patients.

You may not qualify if:

• Patients with active infection, malignancy, autoimmune disease, and on current anticoagulant therapy.
• Patient on chemotherapy during the last 5 years.
• patients on topical or systemic treatment of AGA

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasr El Ainy hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Asmaa S Aamer, resident

CONTACT

01017762819; asmaaaamer0@gmail.com

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
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dermatology resident

Model Details: each patient will receive single session of SVF in one half of the frontal scalp \& single session of PRP in the other half of the scalp to compare the effectiveness of them in AGA treatment

Study Record Dates

• First Submitted: February 18, 2024
• First Posted: August 16, 2024
• Study Start: August 30, 2024
• Primary Completion: October 1, 2024
• Study Completion: April 1, 2025
• Last Updated: August 16, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)