drugset / Trial / NCT06239207

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

NCT06239207

Phase 2 Completed 30 enrolled Services Hospital, Lahore
RandomizedParallel-groupOpen-labelTreatment

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

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject GFC CELL EXO SCALP KIT Unknown 0.1 ml Other
Comparator Platelet Rich Plasma Other / unclassified 0.1 ml Other

Indications