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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Platelet Rich Plasma first, then Minoxidil Foam | Experimental | 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. |
|
| Minoxidil Foam first, then Platelet Rich Plasma | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Platelet Rich Plasma | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline, after 12 weeks of treatment |
| 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. | baseline, after 12 weeks of treatment |
| 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. | baseline, after 12 weeks of treatment |
| 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. | baseline, after 12 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event of Swelling on Scalp | Total number of participants experiencing swelling on scalp was measured after both interventions, in each Arm/Group. | after 12 weeks of treatment |
| Adverse Event of Redness on Scalp |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alison Bruce, M.B. Ch.B | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Florida | Jacksonville | Florida | 32224 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31574029 | Derived | 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. |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (12 Weeks) |
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| Washout (2 Months) |
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| Second Intervention (12 Weeks) |
|
Phototrichogram Analysis, Vellus Hair Density, Quality of Life (QoL)
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | One subject dropped out of the study after received PRP treatment only. This subject is included in results information regarding PRP only. | Posted | Median | Inter-Quartile Range | percent change | baseline, after 12 weeks of treatment |
|
Adverse events were assessed during first treatment period, washout period, second treatment period and follow up period for a total of approximately 1 year.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Platelet Rich Plasma | Subjects who received PRP in either the first or last 12 weeks of the study 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alison J. Bruce, M.B., Ch.B | Mayo Clinic | 904-953-6412 | Bruce.Alison@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 1, 2016 | May 9, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D008914 | Minoxidil |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
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|
| Minoxidil Foam | Drug | Minoxidil 5% topical foam will be applied once daily following manufacturer's instructions for a total of 12 weeks. |
|
|
Total number of participants experiencing Redness on Scalp was measured after both interventions, in each Arm/Group.
| after 12 weeks of treatment |
| NOT COMPLETED |
|
| NOT COMPLETED |
|
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Subjects who received Minoxidil either the first or last 12 weeks of the study. |
|
|
|
| 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. | One subject dropped out of the study after received PRP treatment only. This subject is included in results information regarding PRP only. | Posted | Median | Inter-Quartile Range | percent change | baseline, after 12 weeks of treatment |
|
|
|
|
| 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. | One subject dropped out of the study after received PRP treatment only. This subject is included in results information regarding PRP only. | Posted | Median | Inter-Quartile Range | percent change | baseline, after 12 weeks of treatment |
|
|
|
|
| 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. | One subject dropped out of the study after received PRP treatment only. This subject is included in results information regarding PRP only. | Posted | Median | Inter-Quartile Range | percent change | baseline, after 12 weeks of treatment |
|
|
|
|
| Secondary | Adverse Event of Swelling on Scalp | Total number of participants experiencing swelling on scalp was measured after both interventions, in each Arm/Group. | Posted | Count of Participants | Participants | after 12 weeks of treatment |
|
|
|
| Secondary | Adverse Event of Redness on Scalp | Total number of participants experiencing Redness on Scalp was measured after both interventions, in each Arm/Group. | Posted | Count of Participants | Participants | after 12 weeks of treatment |
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 3 |
| 19 |
| EG001 | Minoxidil Foam | Subjects who received Minoxidil either the first or last 12 weeks of the study Minoxidil 5% topical foam will be applied once daily following manufacturer's instructions for a total of 12 weeks. | 0 | 18 | 0 | 18 | 1 | 18 |
| Itching | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Bruising | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |