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Trial Outcomes & Findings for The Effect of Platelet Rich Plasma on Non-scarring Alopecia (NCT NCT03689452)

NCT ID: NCT03689452

Last Updated: 2020-10-30

Results Overview

Number of participants with improvement by qualitative global assessment of hair growth using photography. Photographs of the scalp with standard digital camera used to assess overall change in hair appearance on a macroscopic level. This will be done using the Ludwig Classification system. I is appreciable thinning of the crown hair, II is increased territorial involvement and scalp visibility, and III is total denudation of the areas involved in I and II

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

through study completion, 24 weeks

Results posted on

2020-10-30

Participant Flow

Participant milestones

Participant milestones
Measure
Platelet Rich Plasma (PRP) Group
4.0 mL of Platelet Rich Plasma (PRP), an autologous concentration of human platelets that is 3 to 5 times greater than physiologic concentration of platelets in whole blood, injected in a standardized pattern with each injection 1-2 cm apart with 0.2 mL per injection.
Placebo Group
4.0 mL of Preservative-free normal saline injected in a standardized pattern with each injection 1-2 cm apart with 0.2 mL per injection.
Overall Study
STARTED
15
15
Overall Study
COMPLETED
14
14
Overall Study
NOT COMPLETED
1
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Platelet Rich Plasma (PRP) Group
4.0 mL of Platelet Rich Plasma (PRP), an autologous concentration of human platelets that is 3 to 5 times greater than physiologic concentration of platelets in whole blood, injected in a standardized pattern with each injection 1-2 cm apart with 0.2 mL per injection.
Placebo Group
4.0 mL of Preservative-free normal saline injected in a standardized pattern with each injection 1-2 cm apart with 0.2 mL per injection.
Overall Study
Lost to Follow-up
1
1

Baseline Characteristics

The Effect of Platelet Rich Plasma on Non-scarring Alopecia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Platelet-rich Plasma Group
n=15 Participants
4.0 mL of Platelet Rich Plasma (PRP), an autologous concentration of human platelets that is 3 to 5 times greater than physiologic concentration of platelets in whole blood, injected in a standardized pattern with each injection 1-2 cm apart with 0.2 mL per injection.
Placebo Group
n=15 Participants
4.0 mL of Preservative-free normal saline injected in a standardized pattern with each injection 1-2 cm apart with 0.2 mL per injection.
Total
n=30 Participants
Total of all reporting groups
Age, Continuous
47 years
n=5 Participants
53 years
n=7 Participants
50 years
n=5 Participants
Sex: Female, Male
Female
15 Participants
n=5 Participants
15 Participants
n=7 Participants
30 Participants
n=5 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race/Ethnicity, Customized
Caucasian
8 Participants
n=5 Participants
7 Participants
n=7 Participants
15 Participants
n=5 Participants
Race/Ethnicity, Customized
Hispanic
5 Participants
n=5 Participants
7 Participants
n=7 Participants
12 Participants
n=5 Participants
Race/Ethnicity, Customized
Other
2 Participants
n=5 Participants
1 Participants
n=7 Participants
3 Participants
n=5 Participants
Hair Loss
67 months
n=5 Participants
93 months
n=7 Participants
80 months
n=5 Participants
Ludwig Score
I
8 Participants
n=5 Participants
9 Participants
n=7 Participants
17 Participants
n=5 Participants
Ludwig Score
II
6 Participants
n=5 Participants
5 Participants
n=7 Participants
11 Participants
n=5 Participants
Ludwig Score
III
1 Participants
n=5 Participants
1 Participants
n=7 Participants
2 Participants
n=5 Participants
Hair Density
556 hairs/cm^2
n=5 Participants
598 hairs/cm^2
n=7 Participants
577 hairs/cm^2
n=5 Participants
Hair Caliber
0.0509 mm
n=5 Participants
0.0570 mm
n=7 Participants
0.0540 mm
n=5 Participants

PRIMARY outcome

Timeframe: through study completion, 24 weeks

Number of participants with improvement by qualitative global assessment of hair growth using photography. Photographs of the scalp with standard digital camera used to assess overall change in hair appearance on a macroscopic level. This will be done using the Ludwig Classification system. I is appreciable thinning of the crown hair, II is increased territorial involvement and scalp visibility, and III is total denudation of the areas involved in I and II

Outcome measures

Outcome measures
Measure
Platelet-rich Plasma Group
n=14 Participants
4.0 mL of Platelet Rich Plasma (PRP), an autologous concentration of human platelets that is 3 to 5 times greater than physiologic concentration of platelets in whole blood, injected in a standardized pattern with each injection 1-2 cm apart with 0.2 mL per injection.
Placebo Group
n=14 Participants
4.0 mL of Preservative-free normal saline injected in a standardized pattern with each injection 1-2 cm apart with 0.2 mL per injection.
Number of Participants With Improvement
8 Participants
1 Participants

PRIMARY outcome

Timeframe: Week 8 and 24

Change in Hair Caliber using trichoscopy as compared to baseline. Trichoscopy is a microscope used to assess hair. This was used to measure hair caliber in millimeters.

Outcome measures

Outcome measures
Measure
Platelet-rich Plasma Group
n=14 Participants
4.0 mL of Platelet Rich Plasma (PRP), an autologous concentration of human platelets that is 3 to 5 times greater than physiologic concentration of platelets in whole blood, injected in a standardized pattern with each injection 1-2 cm apart with 0.2 mL per injection.
Placebo Group
n=14 Participants
4.0 mL of Preservative-free normal saline injected in a standardized pattern with each injection 1-2 cm apart with 0.2 mL per injection.
Change in Hair Caliber Using Trichoscopy
Week 24
0.0053 mm
Standard Deviation 0.0061
-0.0060 mm
Standard Deviation 0.0063
Change in Hair Caliber Using Trichoscopy
Week 8
0.0043 mm
Standard Deviation 0.0024
-0.0034 mm
Standard Deviation 0.0049

PRIMARY outcome

Timeframe: Week 8 and 24

Change in Hair Density using trichoscopy as compared to baseline. Trichoscopy is a microscope used to assess hair. This was used to measure hair density (number of hairs in a square centimeter of scalp).

Outcome measures

Outcome measures
Measure
Platelet-rich Plasma Group
n=14 Participants
4.0 mL of Platelet Rich Plasma (PRP), an autologous concentration of human platelets that is 3 to 5 times greater than physiologic concentration of platelets in whole blood, injected in a standardized pattern with each injection 1-2 cm apart with 0.2 mL per injection.
Placebo Group
n=14 Participants
4.0 mL of Preservative-free normal saline injected in a standardized pattern with each injection 1-2 cm apart with 0.2 mL per injection.
Change in Hair Density Using Trichoscopy
Week 8
71.1 hairs/cm^2
Standard Deviation 40.8
-26.7 hairs/cm^2
Standard Deviation 46.7
Change in Hair Density Using Trichoscopy
Week 24
105.9 hairs/cm^2
Standard Deviation 102.9
-52.4 hairs/cm^2
Standard Deviation 53.0

SECONDARY outcome

Timeframe: Week 40

Population: Data not collected

Surveys will be distributed to assess participant opinion regarding overall hair growth after treatment. This will be done using a hair growth scale in which 0 is no improvement in hair growth and 10 is greatly improved hair growth.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 40

Population: Data not collected

Surveys will be distributed to assess participant opinion regarding the degree of pain associated with the treatment. This will be done using a pain scale of 0 to 10 with 0 being no pain and 10 being worst pain ever.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 40

Population: Data not collected at 40 weeks.

Questionnaires will be distributed to assess participant opinion regarding adverse effects associated with the treatment. This will be assessed via a multiple choice questionnaire with the following options: i. Headache ii. Scalp tightness iii. Swelling iv. Redness v. Post-injection bleeding vi. Infection vii. Nerve damage viii. Other: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ ix. None

Outcome measures

Outcome data not reported

Adverse Events

Platelet-rich Plasma Group

Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths

Placebo Group

Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Platelet-rich Plasma Group
n=14 participants at risk
4.0 mL of Platelet Rich Plasma (PRP), an autologous concentration of human platelets that is 3 to 5 times greater than physiologic concentration of platelets in whole blood, injected in a standardized pattern with each injection 1-2 cm apart with 0.2 mL per injection.
Placebo Group
n=14 participants at risk
4.0 mL of Preservative-free normal saline injected in a standardized pattern with each injection 1-2 cm apart with 0.2 mL per injection.
Nervous system disorders
Headache
50.0%
7/14 • 24 weeks
28.6%
4/14 • 24 weeks
General disorders
Scalp tightness
50.0%
7/14 • 24 weeks
21.4%
3/14 • 24 weeks
Skin and subcutaneous tissue disorders
Swelling
28.6%
4/14 • 24 weeks
0.00%
0/14 • 24 weeks
Skin and subcutaneous tissue disorders
Redness
14.3%
2/14 • 24 weeks
0.00%
0/14 • 24 weeks
Blood and lymphatic system disorders
Post-injection bleeding
7.1%
1/14 • 24 weeks
0.00%
0/14 • 24 weeks
Nervous system disorders
Tingling
7.1%
1/14 • 24 weeks
0.00%
0/14 • 24 weeks

Additional Information

Dr. Danielle P. Dubin

Icahn School of Medicine at Mount Sinai

Phone: 212-731-3311

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: OTHER