Clinical trial NCT03488108: Platelet Rich Plasma Versus Minoxidil Foam for Treatment of Androgenic Alopecia in Women
Official title: A Randomized Controlled Trial Comparing Platelet Rich Plasma (PRP) to Minoxidil Foam for Treatment of Androgenic Alopecia in Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Alopecia
Keywords: growth factors, hair loss, females, regenerative therapy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-04-04
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary objective of this proposal is to conduct a study that assesses the safety, feasibility and efficacy of using PRP to treat this type of hair loss.

Detailed description: Androgenic alopecia (AGA) is a common, progressive hair loss disorder affecting both sexes with significant negative impact on social and psychological well-being. The frequency and severity increases with age, and up to 80% of men, and 50% of women are affected by AGA over the course of their lives. While men are more frequently affected, the psychological impact is likely to be high for women where the social impact of hair loss is often devastating. Current medical therapies specifically approved by the US FDA are limited to minoxidil (for men and women) and finasteride (for men only) (Varothai), but variable responses and the need for indefinite use often result in patient fatigue and suboptimal compliance. Recently, there has been interest in treatments orientated to more biologically regenerative therapies, and consequently there have been numerous studies that have demonstrated successful use for platelet rich plasma (PRP) in treating AGA. PRP contains concentrated platelet cells derived from autologous whole blood that are believed to activate a cascade of growth factors when injected into an area of poor hair growth that stimulates hair growth. In this proposal we will examine whether PRP therapy provides similar or better hair growing capacity in women compared to the conventional topical application minoxidil.

Eligibility criteria: Inclusion Criteria:

1. Only female patients are eligible
2. Patients must be 18 years of age or older
3. Patients must have Androgenic Alopecia Grade I-II by Ludwig Classification
4. Patients must have been on stable birth control if premenopausal.
5. Patients are able and willing to provide written informed consent after the nature of the study is fully explained

Exclusion Criteria:

1. Patients with clinically abnormal hematology, serum chemistry, or screening laboratory results as reviewed by the Principal Investigator
2. Patients who have undergone topical and systemic therapies for hair loss 3 months prior to the procedure
3. Patients who have used any cosmetic product meant to address hair loss 3 months prior to enrollment
4. Patients taking anti-rheumatic disease medication (including methotrexate or other anti-metabolites) within the 3 months prior to study entry.
5. Patients previously having undergone hair transplant surgery prior to study entry
6. Patients who are pregnant or currently breast-feeding children as Rogaine for Women is contra indicated for these women
7. Patients who have taken spironolactone in the 3 months prior to study participation
8. Patients with systemic, rheumatic or inflammatory disease or who are immunosuppressed
9. Patients with ongoing infectious disease, including HIV and hepatitis
10. Patients with clinically significant cardiovascular, renal, hepatic, endocrine disease, cancer, or diabetes
11. Patients participating in a study of an experimental drug or medical device within 30 days of study entry
12. Patients with history of platelet disorders, bone marrow aplasia, sepsis, or cancer in the last 5 years.
13. Patients taking antiaggregating therapy
14. Patients on anticoagulant therapy
15. Patients with tendency to keloid formation
16. Patients with uncompensated diabetes
17. Patients with active skin disease or skin infection at intended treatment areas

Primary outcomes:
measure: Change in Hair Count
timeFrame: baseline, after 12 weeks of treatment
measure: Change in Vellus Hair Density
timeFrame: baseline, after 12 weeks of treatment
measure: Change in Terminal Hair Density
timeFrame: baseline, after 12 weeks of treatment
measure: Change in Cumulative Thickness
timeFrame: baseline, after 12 weeks of treatment
Secondary outcomes:
measure: Adverse Event of Swelling on Scalp
timeFrame: after 12 weeks of treatment
measure: Adverse Event of Redness on Scalp
timeFrame: after 12 weeks of treatment
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Alison Bruce, M.B. Ch.B
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bruce AJ, Pincelli TP, Heckman MG, Desmond CM, Arthurs JR, Diehl NN, Douglass EJ, Bruce CJ, Shapiro SA. A Randomized, Controlled Pilot Trial Comparing Platelet-Rich Plasma to Topical Minoxidil Foam for Treatment of Androgenic Alopecia in Women. Dermatol Surg. 2020 Jun;46(6):826-832. doi: 10.1097/DSS.0000000000002168.