Evaluating the Efficacy of Platelet-rich Plasma Therapy in the Treatment of Androgenic Alopecia

Study Overview
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Brief Summary
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The study team will assess the efficacy of platelet-rich plasma therapy, a special blood product which is from the participant's own body, in the treatment of androgenic alopecia (also known as male pattern hair loss) in females.

Detailed Description
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Androgenic alopecia, or male-pattern hair loss affects both men and women. This hair loss pattern is typically characterized by thinning at the crown of scalp and/or M-shaped hair line in males or diffuse thinning throughout in females. Platelet-rich plasma (PRP) therapy has recently been studied as a hair rejuvenation therapy in patients with non-inflammatory alopecia. Though the mechanism of action is not well understood, PRP is thought to promote angiogenesis and enhance blood flow around hair follicles via platelet-derived growth factor (PDGF), transforming growth factor (TGF), and vascular endothelial growth factor (VEGF). The primary objective of the study is to determine whether PRP, administered once monthly for 3 months improves clinical outcomes and quality of life in females with androgenic alopecia. This is a randomized, placebo-controlled, double-blind, half-head, single center clinical study where sixteen subjects with androgenic alopecia will be recruited. Dermatology Life Quality Index will be assessed at several time points. Disease severity will be measured using the Severity of Alopecia Tool (SALT), Alopecia Density and Extent Score (ALODEX); Trichoscan images will be captured to document participants' clinical progress. Adverse events will be recorded at each visit, treatment will be discontinued if any subject experience a serious adverse event. Treatment visits will take place at baseline, 4 weeks (1 month), 8 weeks (2 months), and 12 weeks (3 month). A follow-up, non-treatment visit will take place at 24 weeks (6 months). The study team hypothesizes that PRP will improve DLQI, SALT, ALODEX, hair count (number of hairs/0.65 cm2), hair density (number of hairs/cm2), hair diameter, anagen to telogen ratio, and vellus hair to terminal hair ratio in female subjects with androgenic alopecia.

Official Title
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Evaluating the Efficacy of Platelet-rich Plasma Therapy in the Treatment of Androgenic Alopecia

Conditions
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Androgenic Alopecia

Intervention / Treatment
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* Biological: Platelet-rich Plasma Left Side
* Biological: Platelet-rich Plasma Right Side


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female ≥18 years of age at baseline visit. Documentation of androgenic alopecia diagnosis as evidenced by one or more clinical features Not currently on any treatment for alopecia, or has undergone 2-week washout period if recently on medication(s) for alopecia Written informed consent obtained from subject and ability for subject to comply with the requirements of the study Exclusion Criteria: Pregnant or breastfeeding Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data. Have an infection, metastatic disease or certain skin conditions (ie. Psoriasis) which could worsen or spread with injections Diagnosed with a blood or bleeding disorder Diagnosed with anemia Currently on anticoagulant therapy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>At the baseline visit subjects will be randomized to either group A or group B. Group A will receive PRP on left side of scalp and placebo (saline solution) on right side of scalp. | Biological: Platelet-rich Plasma Left Side<br>* Group A will receive PRP on left side of scalp and placebo (saline solution) on right side of scalp.<br>|
| Experimental: Group B<br>At the baseline visit subjects will be randomized to either group A or group B. Group B will receive PRP on right side of scalp and placebo (saline solution) on left side of scalp. | Biological: Platelet-rich Plasma Right Side<br>* Group B will receive PRP on right side of scalp and placebo (saline solution) on left side of scalp.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Severity of Alopecia Tool (SALT) from baseline | Change in Severity of Alopecia Tool (SALT) from baseline. SALT scoring - This calculation is based on a scoring system. The scalp is divided into the following 4 areas: Vertex: 40% (0.4) of scalp surface area. Right profile of scalp: 18% (0.18) of scalp surface area. Left profile of scalp: 18% (0.18) of scalp surface area. Posterior aspect of scalp: 24% (0.24) of scalp surface area. Percentage of hair loss in any of these areas is the percentage hair loss multiplied by percent surface area of the scalp in that area. SALT score is the sum of percentage of hair loss in all the above-mentioned areas. For e.g., if the percentage hair loss in vertex, right profile, left profile and posterior aspect is 20, 30, 40 and 50% respecively; then, SALT score = (20 ´ 0.4) = (30 ´ 0.18) + (40 ´ 0.18) + (50 ´ 0.24) = 8+5.4+7.2+12 = 32.6 Lower score denote better outcomes. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hair Count (number of hairs/0.65cm^2) | Change in Hair Count (number of hairs/0.65cm^2), as assessed via Trichoscan | 6 months | 
| Change in Hair Density (number of hairs/cm^2) | Change in Hair Density (number of hairs/cm^2), as assessed via Trichoscan | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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scalp, hair loss, platelet-rich plasma therapy