Androgenetic Alopecia Clinical Trial
Official title:
Efficacy and Safety of Exosomes Versus Platelet Rich Plasma in Patients of Androgenetic Alopecia
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
Status | Recruiting |
Enrollment | 30 |
Est. completion date | July 21, 2024 |
Est. primary completion date | July 21, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - All patients with androgenetic alopecia - age from 18 to 70 years - Sex: male and female Exclusion criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Pakistan | Services Hospital | Lahore | Punjab |
Lead Sponsor | Collaborator |
---|---|
Services Hospital, Lahore |
Pakistan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | More than 25% increase in hair density | hairs per cm square measured by trichoscopy | 6 months after last session | |
Secondary | > 25% improvement response in Physician Global assesment | 3 point scoring system ,,score 1 satisfactory response >25% improvement, score 2 25-50% improvement good response, score 3 >50% improvement excellent response | 6 months after last sessions | |
Secondary | > 25% improvement response in Patient Global assesment | 3 point scoring system ,,score 1 satisfactory response >25% improvement, score 2 25-50% improvement good response, score 3 >50% improvement excellent response | 6 months after last sessions |
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