Alopecia
Conditions
Keywords
growth factors, hair loss, females, regenerative therapy
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.
Interventions
OTHERPlatelet Rich Plasma
Autologous Platelet Rich Plasma (PRP) will be isolated from blood collected from each subject at each treatment time point. 100 cc of PRP will be injected with a 30-gauge needle over the affected part of the scalp, approximately 1/10 cc/injection site. Treatments will take place every 4 weeks for a total of 3 treatments over 12 weeks.
DRUGMinoxidil Foam
Minoxidil 5% topical foam will be applied once daily following manufacturer's instructions for a total of 12 weeks.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hair Count | baseline, after 12 weeks of treatment | Phototrichograms of all scalps performed using FotoFinder video-epiluminescence microscopy (FotoFinder Systems GmbH) in combination with TrichoScan digital image analysis (TRICHOLOG GmbH and DatInf mbH). The percent change in the total number of hairs per 0.65 cm2 was measured after both interventions, in each Arm/Group. |
| Change in Vellus Hair Density | baseline, after 12 weeks of treatment | Phototrichograms of all scalps performed using FotoFinder video-epiluminescence microscopy (FotoFinder Systems GmbH) in combination with TrichoScan digital image analysis (TRICHOLOG GmbH and DatInf mbH). The percent change in the total number of vellus hairs per cm2 was measured after both interventions, in each Arm/Group. |
| Change in Terminal Hair Density | baseline, after 12 weeks of treatment | Phototrichograms of all scalps performed using FotoFinder video-epiluminescence microscopy (FotoFinder Systems GmbH) in combination with TrichoScan digital image analysis (TRICHOLOG GmbH and DatInf mbH). The percent change in the total number of Terminal hairs per cm2 was measured after both interventions, in each Arm/Group. |
| Change in Cumulative Thickness | baseline, after 12 weeks of treatment | Phototrichograms of all scalps performed using FotoFinder video-epiluminescence microscopy (FotoFinder Systems GmbH) in combination with TrichoScan digital image analysis (TRICHOLOG GmbH and DatInf mbH). The percent change in the total sum of thickness of each hair was measured after both interventions, in each Arm/Group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Event of Swelling on Scalp | after 12 weeks of treatment | Total number of participants experiencing swelling on scalp was measured after both interventions, in each Arm/Group. |
| Adverse Event of Redness on Scalp | after 12 weeks of treatment | Total number of participants experiencing Redness on Scalp was measured after both interventions, in each Arm/Group. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Platelet Rich Plasma First, Then Minoxidil Foam Subjects who received PRP in either the first or last 12 weeks of the study
Subjects will be randomized into the Platelet Rich Plasma group, treated for 12 weeks with a 2 month washout period in between treatments, then treated with Minoxidil Foam for 12 weeks.
Platelet Rich Plasma: Autologous Platelet Rich Plasma (PRP) will be isolated from blood collected from each subject at each treatment time point. 100 cc of PRP will be injected with a 30-gauge needle over the affected part of the scalp, approximately 1/10 cc/injection site. Treatments will take place every 4 weeks for a total of 3 treatments over 12 weeks.
Minoxidil Foam: Minoxidil 5% topical foam will be applied once daily following manufacturer's instructions for a total of 12 weeks. | 10 |
| Minoxidil Foam First, Then Platelet Rich Plasma Subjects who received Minoxidil either the first or last 12 weeks of the study
Subjects will be randomized into the Minoxidil Foam group, treated for 12 weeks with a 2 month washout period in between treatments, then treated with Platelet Rich Plasma.
Platelet Rich Plasma: Autologous Platelet Rich Plasma (PRP) will be isolated from blood collected from each subject at each treatment time point. 100 cc of PRP will be injected with a 30-gauge needle over the affected part of the scalp, approximately 1/10 cc/injection site. Treatments will take place every 4 weeks for a total of 3 treatments over 12 weeks.
Minoxidil Foam: Minoxidil 5% topical foam will be applied once daily following manufacturer's instructions for a total of 12 weeks. | 9 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention (12 Weeks) | Withdrawal by Subject | 0 | 1 |
| Second Intervention (12 Weeks) | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Platelet Rich Plasma First, Then Minoxidil Foam | Total | Minoxidil Foam First, Then Platelet Rich Plasma |
|---|---|---|---|
| Age, Continuous | 51 years | 56 years | 56 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 10 Participants | 19 Participants | 9 Participants |
| Region of Enrollment United States | 10 participants | 19 participants | 9 participants |
| Sex: Female, Male Female | 10 Participants | 19 Participants | 9 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 18 |
| other Total, other adverse events | 3 / 19 | 1 / 18 |
| serious Total, serious adverse events | 0 / 19 | 0 / 18 |
Outcome results
Primary
Change in Cumulative Thickness
Phototrichograms of all scalps performed using FotoFinder video-epiluminescence microscopy (FotoFinder Systems GmbH) in combination with TrichoScan digital image analysis (TRICHOLOG GmbH and DatInf mbH). The percent change in the total sum of thickness of each hair was measured after both interventions, in each Arm/Group.
Time frame: baseline, after 12 weeks of treatment
Population: One subject dropped out of the study after received PRP treatment only. This subject is included in results information regarding PRP only.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Platelet Rich Plasma | Change in Cumulative Thickness | -3.5 percent change |
| Minoxidil Foam | Change in Cumulative Thickness | 20.6 percent change |
p-value: 0.005Wilcoxon (Mann-Whitney)
Primary
Change in Hair Count
Phototrichograms of all scalps performed using FotoFinder video-epiluminescence microscopy (FotoFinder Systems GmbH) in combination with TrichoScan digital image analysis (TRICHOLOG GmbH and DatInf mbH). The percent change in the total number of hairs per 0.65 cm2 was measured after both interventions, in each Arm/Group.
Time frame: baseline, after 12 weeks of treatment
Population: One subject dropped out of the study after received PRP treatment only. This subject is included in results information regarding PRP only.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Platelet Rich Plasma | Change in Hair Count | 7.7 percent change |
| Minoxidil Foam | Change in Hair Count | 22.7 percent change |
p-value: 0.009Wilcoxon (Mann-Whitney)
Primary
Change in Terminal Hair Density
Phototrichograms of all scalps performed using FotoFinder video-epiluminescence microscopy (FotoFinder Systems GmbH) in combination with TrichoScan digital image analysis (TRICHOLOG GmbH and DatInf mbH). The percent change in the total number of Terminal hairs per cm2 was measured after both interventions, in each Arm/Group.
Time frame: baseline, after 12 weeks of treatment
Population: One subject dropped out of the study after received PRP treatment only. This subject is included in results information regarding PRP only.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Platelet Rich Plasma | Change in Terminal Hair Density | -0.7 percent change |
| Minoxidil Foam | Change in Terminal Hair Density | 12.8 percent change |
p-value: 0.003Wilcoxon (Mann-Whitney)
Primary
Change in Vellus Hair Density
Phototrichograms of all scalps performed using FotoFinder video-epiluminescence microscopy (FotoFinder Systems GmbH) in combination with TrichoScan digital image analysis (TRICHOLOG GmbH and DatInf mbH). The percent change in the total number of vellus hairs per cm2 was measured after both interventions, in each Arm/Group.
Time frame: baseline, after 12 weeks of treatment
Population: One subject dropped out of the study after received PRP treatment only. This subject is included in results information regarding PRP only.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Platelet Rich Plasma | Change in Vellus Hair Density | 25.7 percent change |
| Minoxidil Foam | Change in Vellus Hair Density | 18.6 percent change |
p-value: 0.9Wilcoxon (Mann-Whitney)
Secondary
Adverse Event of Redness on Scalp
Total number of participants experiencing Redness on Scalp was measured after both interventions, in each Arm/Group.
Time frame: after 12 weeks of treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Platelet Rich Plasma | Adverse Event of Redness on Scalp | 0 Participants |
| Minoxidil Foam | Adverse Event of Redness on Scalp | 0 Participants |
Secondary
Adverse Event of Swelling on Scalp
Total number of participants experiencing swelling on scalp was measured after both interventions, in each Arm/Group.
Time frame: after 12 weeks of treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Platelet Rich Plasma | Adverse Event of Swelling on Scalp | 0 Participants |
| Minoxidil Foam | Adverse Event of Swelling on Scalp | 0 Participants |