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Efficacy and Safety of Exosomes Versus Platelet Rich Plasma in Patients of Androgenetic Alopecia

NCT06239207 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-10-22

No results posted yet for this study

Summary

Androgenetic alopecia is a common condition affects both genders. Patients of androgenetic alopecia following inclusion criteria will be enrolled after ethical approval and informed consent. Pre-treatment assessment will be done by Physian Global assessment, Patient global assessment and hair density by trichoscopy of areas under treatment. Patients will be categorized in 2 groups. Group A receiving exosomes 1session intradermally in scalp after nerve block and group B receiving PRP 2 sessions of PRP 1 month apart intradermally in scalp after nerve block. Patients will receive exosomes at strength of 2 to 10 billion particles/5ml with 0.1 ml/cm2. Follow up will be done after 1 month, 2 months, 3 months, 5 months and 6 months of completion of treatment to assess hair growth and reduce hair fall by Physian Global assessment (PGA), Patient global assessment (PtGA) and trichography. Clinical response will be graded as satisfactory (\< 25%), good (25-50%) or excellent (\> 50%) improvement. Details will be entered on predesigned proforma. Data will be entered and analyzed using SPSS 27. Means will be calculated for quantitative variables, frequencies for qualitative variables like pre- and post treatment response. Data will be stratified for role of effect modifiers

Conditions

Interventions

BIOLOGICAL

Exosomes GFC CELL EXO SCALP KIT (Leuco Exo 97%)

Exosomes used are GFC CELL, consist of Leuco exo 97% having GFC CELL EXO SCALP 9700 powder and EXO SCALP Pep9 solution

BIOLOGICAL

Platelet Rich Plasma

PRP is prepared under aseptic precautions, around 10ml of blood is collected in PRP tubes which are rotated in a centrifuge machine at 1500 RPM for 10 minutes. Which separates the blood into 2 layers: the lower RBC layer; the upper acellular plasma layer. The buffy coat along with the plasma was collected with a pipette and transferred into another test tube underwent 2nd spin at 4000 RPM for 10 min. This PRP was collected in another clean tube to be used as plasma

Sponsors & Collaborators

  • Services Hospital, Lahore

    lead OTHER_GOV

Principal Investigators

  • Alina Abbass, MBBS, FCPS · Services Institute of medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-21
Primary Completion
2024-07-21
Completion
2024-07-21

Countries

  • Pakistan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06239207 on ClinicalTrials.gov