The Effect of Platelet Rich Plasma on Non-scarring Alopecia
Primary Purpose
Androgenetic Alopecia, Alopecia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Platelet Rich Plasma
Normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Androgenetic Alopecia
Eligibility Criteria
Inclusion Criteria:
- Must understand and voluntarily sign an informed consent form
- Must be female between the ages of 18 and 65 years at the time of consent
- Must be able to adhere to the study visit schedule and other protocol requirements
- Documented platelet count above 150,000 platelets per microliter within 6 months prior to enrollment
Exclusion Criteria:
- Previous or current use in the last 1 year of finasteride, minoxidil topical or oral, or spironolactone
- A diagnosis of non-androgenic alopecia (i.e: another diagnosis for the alopecia )
- No Baseline ferritin, thyroid-stimulating hormone, platelet count, and a negative urine pregnancy test in any pre-menopausal female in past 12 months.
- Active skin disease (Psoriasis or severe seborrheic dermatitis) of the scalp
- Scalp infection
- Severe active blood infection
- Cuts or abrasions on the scalp
- History of surgical hair restoration
- Current or recent malignancy
- History of systemic chemotherapy or radiation
- History of thyroid dysfunction
- History of autoimmune disorder (specifically Graves disease, hashimoto thyroiditis, or systemic lupus erythematosus)
- Tendency to develop keloids
- Nonsteroidal anti-inflammatory or Vitamin E discontinued in the last 7-14 days
- Platelet dysfunction syndrome
- Thrombocytopenia less than 150,000
- Diagnosis of hypofibrinogenemia
- Anticipated pregnancy or trying to become pregnant in the next 2 years
Sites / Locations
- Icahn School of Medicine at Mount Sinai
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Control
Treatment
Arm Description
15 participants will receive 3 mL of preservative free normal saline injected in a standardized pattern with each injection 1-2 cm apart with 0.2 to 0.3 mL per injection. Participants will receive this treatment at weeks 0, 4, 8, and 24.
15 participants will receive 3-6 mL of platelet rich plasma injected in a standardized pattern with each injection 1-2 cm apart with 0.2 to 0.3 mL per injection. Participants will receive this treatment at weeks 0, 4, 8, and 24.
Outcomes
Primary Outcome Measures
Number of Participants With Improvement
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
Change in Hair Caliber Using Trichoscopy
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.
Change in Hair Density Using Trichoscopy
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).
Secondary Outcome Measures
Qualitative Assessment of Hair Growth
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.
Qualitative Assessment of Pain Associated With the Treatment
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.
Qualitative Assessment of Adverse Effects Associated With the Treatment
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
Full Information
NCT ID
NCT03689452
First Posted
September 20, 2018
Last Updated
October 8, 2020
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
Eclipse Aesthetics, LLC
1. Study Identification
Unique Protocol Identification Number
NCT03689452
Brief Title
The Effect of Platelet Rich Plasma on Non-scarring Alopecia
Official Title
The Effect of Platelet Rich Plasma on Non-scarring Alopecia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
June 3, 2019 (Actual)
Study Completion Date
June 3, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
Eclipse Aesthetics, LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the clinical efficacy of platelet rich plasma (PRP) injections for non-scaring alopecia in women. A randomized, placebo-controlled clinical trial will be performed where patients with non-scarring alopecia will either receive injections of their own PRP or injections of normal saline (placebo). Patients in the treatment group (Group A) will have a small amount of their own blood drawn and have their PRP injected into their scalp four times. The injections will be given at weeks zero, four, eight, and twenty four. The placebo group (Group B) will be given the same schedule but will receive sham injections only and will not have any blood drawn. Both groups will have clinical data collected at all visits, including a screening visit before enrollment and a final assessment visit at week 40, for a total of 6 study visits per patient. Data collection will include representative photographs of the scalp and measurements of hair thickness. The results from the two groups will then be compared.
In summary, all study participants will have a screening visit before enrollment, four study visits for sub-dermal scalp injections, and one final assessment visit at week 40.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Androgenetic Alopecia, Alopecia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
15 participants will receive 3 mL of preservative free normal saline injected in a standardized pattern with each injection 1-2 cm apart with 0.2 to 0.3 mL per injection. Participants will receive this treatment at weeks 0, 4, 8, and 24.
Arm Title
Treatment
Arm Type
Experimental
Arm Description
15 participants will receive 3-6 mL of platelet rich plasma injected in a standardized pattern with each injection 1-2 cm apart with 0.2 to 0.3 mL per injection. Participants will receive this treatment at weeks 0, 4, 8, and 24.
Intervention Type
Device
Intervention Name(s)
Platelet Rich Plasma
Intervention Description
Platelet Rich Plasma (PRP) is defined as an autologous concentration of human platelets that is 3 to 5 times greater than physiologic concentration of platelets in whole blood. Using the Eclipse PRP system, the participants PRP will be attained. The PRP will then be used as described in the arm/group description section.
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
Preservative-free normal saline will be used as described in arm/group description section.
Primary Outcome Measure Information:
Title
Number of Participants With Improvement
Description
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
Time Frame
through study completion, 24 weeks
Title
Change in Hair Caliber Using Trichoscopy
Description
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.
Time Frame
Week 8 and 24
Title
Change in Hair Density Using Trichoscopy
Description
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).
Time Frame
Week 8 and 24
Secondary Outcome Measure Information:
Title
Qualitative Assessment of Hair Growth
Description
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.
Time Frame
Week 40
Title
Qualitative Assessment of Pain Associated With the Treatment
Description
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.
Time Frame
Week 40
Title
Qualitative Assessment of Adverse Effects Associated With the Treatment
Description
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
Time Frame
Week 40
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Must understand and voluntarily sign an informed consent form
Must be female between the ages of 18 and 65 years at the time of consent
Must be able to adhere to the study visit schedule and other protocol requirements
Documented platelet count above 150,000 platelets per microliter within 6 months prior to enrollment
Exclusion Criteria:
Previous or current use in the last 1 year of finasteride, minoxidil topical or oral, or spironolactone
A diagnosis of non-androgenic alopecia (i.e: another diagnosis for the alopecia )
No Baseline ferritin, thyroid-stimulating hormone, platelet count, and a negative urine pregnancy test in any pre-menopausal female in past 12 months.
Active skin disease (Psoriasis or severe seborrheic dermatitis) of the scalp
Scalp infection
Severe active blood infection
Cuts or abrasions on the scalp
History of surgical hair restoration
Current or recent malignancy
History of systemic chemotherapy or radiation
History of thyroid dysfunction
History of autoimmune disorder (specifically Graves disease, hashimoto thyroiditis, or systemic lupus erythematosus)
Tendency to develop keloids
Nonsteroidal anti-inflammatory or Vitamin E discontinued in the last 7-14 days
Platelet dysfunction syndrome
Thrombocytopenia less than 150,000
Diagnosis of hypofibrinogenemia
Anticipated pregnancy or trying to become pregnant in the next 2 years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hooman Khorasani, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10028
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Raw individual participant data will not be shared with other researchers in an effort to preserve participant confidentiality.
Learn more about this trial
The Effect of Platelet Rich Plasma on Non-scarring Alopecia
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