Trial Outcomes & Findings for Platelet Rich Plasma Versus Minoxidil Foam for Treatment of Androgenic Alopecia in Women (NCT NCT03488108)
NCT ID: NCT03488108
Last Updated: 2020-04-08
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
20 participants
Primary outcome timeframe
baseline, after 12 weeks of treatment
Results posted on
2020-04-08
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
First Intervention (12 Weeks)
STARTED
|
10
|
10
|
|
First Intervention (12 Weeks)
COMPLETED
|
10
|
9
|
|
First Intervention (12 Weeks)
NOT COMPLETED
|
0
|
1
|
|
Washout (2 Months)
STARTED
|
10
|
9
|
|
Washout (2 Months)
COMPLETED
|
10
|
9
|
|
Washout (2 Months)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (12 Weeks)
STARTED
|
10
|
9
|
|
Second Intervention (12 Weeks)
COMPLETED
|
9
|
9
|
|
Second Intervention (12 Weeks)
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
First Intervention (12 Weeks)
Withdrawal by Subject
|
0
|
1
|
|
Second Intervention (12 Weeks)
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Platelet Rich Plasma Versus Minoxidil Foam for Treatment of Androgenic Alopecia in Women
Baseline characteristics by cohort
| Measure |
Platelet Rich Plasma First, Then Minoxidil Foam
n=10 Participants
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.
|
Minoxidil Foam First, Then Platelet Rich Plasma
n=9 Participants
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.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51 years
n=5 Participants
|
56 years
n=7 Participants
|
56 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
9 participants
n=7 Participants
|
19 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, after 12 weeks of treatmentPopulation: One subject dropped out of the study after received PRP treatment only. This subject is included in results information regarding PRP only.
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.
Outcome measures
| Measure |
Platelet Rich Plasma
n=19 Participants
Subjects who received PRP in either the first or last 12 weeks of the study.
|
Minoxidil Foam
n=18 Participants
Subjects who received Minoxidil either the first or last 12 weeks of the study.
|
|---|---|---|
|
Change in Hair Count
|
7.7 percent change
Interval -7.2 to 17.9
|
22.7 percent change
Interval -18.0 to 59.0
|
PRIMARY outcome
Timeframe: baseline, after 12 weeks of treatmentPopulation: One subject dropped out of the study after received PRP treatment only. This subject is included in results information regarding PRP only.
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.
Outcome measures
| Measure |
Platelet Rich Plasma
n=19 Participants
Subjects who received PRP in either the first or last 12 weeks of the study.
|
Minoxidil Foam
n=18 Participants
Subjects who received Minoxidil either the first or last 12 weeks of the study.
|
|---|---|---|
|
Change in Vellus Hair Density
|
25.7 percent change
Interval -37.6 to 121.3
|
18.6 percent change
Interval -29.4 to 166.5
|
PRIMARY outcome
Timeframe: baseline, after 12 weeks of treatmentPopulation: One subject dropped out of the study after received PRP treatment only. This subject is included in results information regarding PRP only.
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.
Outcome measures
| Measure |
Platelet Rich Plasma
n=19 Participants
Subjects who received PRP in either the first or last 12 weeks of the study.
|
Minoxidil Foam
n=18 Participants
Subjects who received Minoxidil either the first or last 12 weeks of the study.
|
|---|---|---|
|
Change in Terminal Hair Density
|
-0.7 percent change
Interval -49.5 to 27.6
|
12.8 percent change
Interval -19.4 to 119.4
|
PRIMARY outcome
Timeframe: baseline, after 12 weeks of treatmentPopulation: One subject dropped out of the study after received PRP treatment only. This subject is included in results information regarding PRP only.
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.
Outcome measures
| Measure |
Platelet Rich Plasma
n=19 Participants
Subjects who received PRP in either the first or last 12 weeks of the study.
|
Minoxidil Foam
n=18 Participants
Subjects who received Minoxidil either the first or last 12 weeks of the study.
|
|---|---|---|
|
Change in Cumulative Thickness
|
-3.5 percent change
Interval -14.1 to 32.2
|
20.6 percent change
Interval -21.3 to 83.3
|
SECONDARY outcome
Timeframe: after 12 weeks of treatmentTotal number of participants experiencing swelling on scalp was measured after both interventions, in each Arm/Group.
Outcome measures
| Measure |
Platelet Rich Plasma
n=19 Participants
Subjects who received PRP in either the first or last 12 weeks of the study.
|
Minoxidil Foam
n=19 Participants
Subjects who received Minoxidil either the first or last 12 weeks of the study.
|
|---|---|---|
|
Adverse Event of Swelling on Scalp
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: after 12 weeks of treatmentTotal number of participants experiencing Redness on Scalp was measured after both interventions, in each Arm/Group.
Outcome measures
| Measure |
Platelet Rich Plasma
n=19 Participants
Subjects who received PRP in either the first or last 12 weeks of the study.
|
Minoxidil Foam
n=19 Participants
Subjects who received Minoxidil either the first or last 12 weeks of the study.
|
|---|---|---|
|
Adverse Event of Redness on Scalp
|
0 Participants
|
0 Participants
|
Adverse Events
Platelet Rich Plasma
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Minoxidil Foam
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Platelet Rich Plasma
n=19 participants at risk
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.
|
Minoxidil Foam
n=18 participants at risk
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.
|
|---|---|---|
|
General disorders
Pain
|
10.5%
2/19 • Number of events 2 • Adverse events were assessed during first treatment period, washout period, second treatment period and follow up period for a total of approximately 1 year.
|
0.00%
0/18 • Adverse events were assessed during first treatment period, washout period, second treatment period and follow up period for a total of approximately 1 year.
|
|
Skin and subcutaneous tissue disorders
Itching
|
5.3%
1/19 • Number of events 1 • Adverse events were assessed during first treatment period, washout period, second treatment period and follow up period for a total of approximately 1 year.
|
0.00%
0/18 • Adverse events were assessed during first treatment period, washout period, second treatment period and follow up period for a total of approximately 1 year.
|
|
Skin and subcutaneous tissue disorders
Bruising
|
0.00%
0/19 • Adverse events were assessed during first treatment period, washout period, second treatment period and follow up period for a total of approximately 1 year.
|
5.6%
1/18 • Number of events 1 • Adverse events were assessed during first treatment period, washout period, second treatment period and follow up period for a total of approximately 1 year.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place