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

Early Phase 1

Not yet recruiting

• Conditions: Androgenic Alopecia
• Interventions: Biological: Platelet-rich Plasma Right Side; Biological: Platelet-rich Plasma Left Side

• Registration Number: NCT03474718
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-03-15
• Study First Submitted QC: 2018-03-15
• Study First Posted: 2018-03-22
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-29
• Last Update Posted: 2024-11-01
• Study Start: 2025-02
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 16

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	Platelet-rich Plasma Right Side	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.
Group A	Platelet-rich Plasma Left Side	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.

Primary Outcome Measures

Name	Time	Method
Change in Severity of Alopecia Tool (SALT) from baseline	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Change in Hair Count (number of hairs/0.65cm^2)	6 months	Change in Hair Count (number of hairs/0.65cm\^2), as assessed via Trichoscan
Change in Hair Density (number of hairs/cm^2)	6 months	Change in Hair Density (number of hairs/cm\^2), as assessed via Trichoscan

Trial Locations

Locations (1)

Wake Forest University Baptist Health; 🇺🇸 Winston-Salem, North Carolina, United States