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

NCT06239207 | Completed Phase 2

• 1 other identifier: IRB/2023/1181/SIMS
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Androgenetic Alopecia

Keywords

Exosomes, Platelet Rich Plasma, Androgenetic Alopecia

Outcome Measures

Primary Outcomes (1)

• More than 25% increase in hair density

  hairs per cm square measured by trichoscopy

  6 months after last session

Secondary Outcomes (2)

• > 25% improvement response in Physician Global assesment

  6 months after last sessions

• > 25% improvement response in Patient Global assesment

  6 months after last sessions

Study Arms (2)

Exosomes

EXPERIMENTAL

Group A patients are injected exosomes 2 session 3 months apart, intradermally at a dose of 0.1 ml/cm2 of scalp. Exosomes used are GFC CELL(TM) EXO SCALP KIT

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

B PRP

ACTIVE COMPARATOR

PRP 4 sessions 1 months apart. Group B patients are injected PRP intradermally in scalp. Uunder aseptic around 10ml of blood is collected from the median cubital vein and is transferred into a sodium citrate tube. Then the tubes are rotated in a centrifuge machine at 1500 RPM for 10 minutes.It separates the blood into 2 layers: the lower RBC layer; the upper plasma layer buffy coat. The buffy coat was transferred into another test tube. This tube was again subjected to a second centrifugation at 4000 RPM for 10 minutes. Both the upper layer containing platelet poor plasma and the lower layer of the PRP was collected. The plasma is filled into insulin syringe and then injected evenly into the affected areas of the scalp. Multiple PRP injections of 0.1 mL were given at each site in a linear pattern 1 cm apart

Biological: Platelet Rich Plasma

Interventions

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

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

Exosomes

Platelet Rich Plasma BIOLOGICAL

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

B PRP

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients with androgenetic alopecia
• age from 18 to 70 years
• Sex: male and female

You may not qualify if:

• Patient with platelets disorders, thrombocytopenia
• Patients using anti-platelet therapy
• Use of pharmacological therapeutics targeting AGA as Finasteride®, use of topical medicines as lotions as Minoxidil®, retinoid, or corticosteroids in the earlier year.
• Patients with bone marrow aplasia, uncontrolled diabetes, sepsis, cancer

Sponsors & Collaborators

• Services Hospital, Lahore: lead

Study Sites (1)

Services Hospital

Lahore, Punjab Province, 56000, Pakistan

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

Study Officials

• Alina Abbass, MBBS, FCPS

  Services Institute of medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Registrar Dermatology

Model Details: A parallel study is a type of clinical study in which two or more groups of participants receive different interventions. Participants are assigned to one of the treatment arms at the beginning of the trial and continue in that arm throughout the length of the trial. Assignment to a group usually is randomized. Study participants are only exposed to the treatment that is assigned to the particular study arm they are enrolled in. So in this study the patients are randomized into two groups by paper lottery method. After regional nerve block under aseptic conditions, Group A patients are injected exosomes intradermally at a strength of 2 to 10 billion particles/5ml, at a dose of 0.1 ml/cm2 of scalp, and group B patients are injected PRP intradermally in scalp

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: February 2, 2024
• Study Start: September 21, 2023
• Primary Completion: July 21, 2024
• Study Completion: July 21, 2024
• Last Updated: October 22, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)