Phase 2
N=20
Platelet Rich Plasma Versus Minoxidil Foam for Treatment of Androgenic Alopecia in Women
Alopecia
Bottom Line
View on ClinicalTrials.gov: NCT03488108 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: Change in Hair Count — 7.7; 22.7 percent change — p=.009
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Platelet Rich Plasma (Other); Minoxidil Foam (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Mayo Clinic
- Primary completion
- May 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Hair Count |
7.7; 22.7 | .009 sig |
| PRIMARY Change in Vellus Hair Density |
25.7; 18.6 | .90 |
| PRIMARY Change in Terminal Hair Density |
-0.7; 12.8 | .003 sig |
| PRIMARY Change in Cumulative Thickness |
-3.5; 20.6 | .005 sig |
| SECONDARY Adverse Event of Swelling on Scalp |
0; 0 | — |
| SECONDARY Adverse Event of Redness on Scalp |
0; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Only female patients are eligible
- Patients must be 18 years of age or older
- Patients must have Androgenic Alopecia Grade I-II by Ludwig Classification
- Patients must have been on stable birth control if premenopausal.
- Patients are able and willing to provide written informed consent after the nature of the study is fully explained
Exclusion Criteria
- Patients with clinically abnormal hematology, serum chemistry, or screening laboratory results as reviewed by the Principal Investigator
- Patients who have undergone topical and systemic therapies for hair loss 3 months prior to the procedure
- Patients who have used any cosmetic product meant to address hair loss 3 months prior to enrollment
- Patients taking anti-rheumatic disease medication (including methotrexate or other anti-metabolites) within the 3 months prior to study entry.
- Patients previously having undergone hair transplant surgery prior to study entry
- Patients who are pregnant or currently breast-feeding children as Rogaine for Women is contra indicated for these women
- Patients who have taken spironolactone in the 3 months prior to study participation
- Patients with systemic, rheumatic or inflammatory disease or who are immunosuppressed
- Patients with ongoing infectious disease, including HIV and hepatitis
- Patients with clinically significant cardiovascular, renal, hepatic, endocrine disease, cancer, or diabetes
- Patients participating in a study of an experimental drug or medical device within 30 days of study entry
- Patients with history of platelet disorders, bone marrow aplasia, sepsis, or cancer in the last 5 years.
- Patients taking antiaggregating therapy
- Patients on anticoagulant therapy
- Patients with tendency to keloid formation
- Patients with uncompensated diabetes
- Patients with active skin disease or skin infection at intended treatment areas
Data sourced from ClinicalTrials.gov (NCT03488108). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.