Clinical trial NCT03474718: Evaluating the Efficacy of Platelet-rich Plasma Therapy in the Treatment of Androgenic Alopecia
Official title: Evaluating the Efficacy of Platelet-rich Plasma Therapy in the Treatment of Androgenic Alopecia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Androgenic Alopecia
Keywords: scalp
hair loss
platelet-rich plasma therapy
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2018-03-22
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Severity of Alopecia Tool (SALT) from baseline
timeFrame: 6 months
Secondary outcomes:
measure: Change in Hair Count (number of hairs/0.65cm^2)
timeFrame: 6 months
measure: Change in Hair Density (number of hairs/cm^2)
timeFrame: 6 months
Other outcomes:
measure: Change in Hair Diameter
timeFrame: 6 months
measure: Anagen to Telogen Ratio
timeFrame: 6 months
measure: Vellus Hair to Terminal Hair Ratio
timeFrame: 6 months
measure: Change in Dermatology Life Quality Index (DLQI)
timeFrame: 6 months
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Baptist Health
state: North Carolina
Study officials:
affiliation: Wake Forest University School of Medicine, Department of Dermatology
name: Rita Pichardo, MD
role: PRINCIPAL_INVESTIGATOR
References: