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Phase 2 N=20 Randomized Treatment

Platelet Rich Plasma Versus Minoxidil Foam for Treatment of Androgenic Alopecia in Women

Alopecia

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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