Alopecia, Androgenetic Alopecia
Conditions
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.
Interventions
DEVICEPlatelet Rich Plasma
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.
DRUGNormal saline
Preservative-free normal saline will be used as described in arm/group description section.
Sponsors
Eclipse Aesthetics, LLC
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Must understand and voluntarily sign an informed consent form 2. Must be female between the ages of 18 and 65 years at the time of consent 3. Must be able to adhere to the study visit schedule and other protocol requirements 4. Documented platelet count above 150,000 platelets per microliter within 6 months prior to enrollment
Exclusion criteria
1. Previous or current use in the last 1 year of finasteride, minoxidil topical or oral, or spironolactone 2. A diagnosis of non-androgenic alopecia (i.e: another diagnosis for the alopecia ) 3. No Baseline ferritin, thyroid-stimulating hormone, platelet count, and a negative urine pregnancy test in any pre-menopausal female in past 12 months. 4. Active skin disease (Psoriasis or severe seborrheic dermatitis) of the scalp 5. Scalp infection 6. Severe active blood infection 7. Cuts or abrasions on the scalp 8. History of surgical hair restoration 9. Current or recent malignancy 10. History of systemic chemotherapy or radiation 11. History of thyroid dysfunction 12. History of autoimmune disorder (specifically Graves disease, hashimoto thyroiditis, or systemic lupus erythematosus) 13. Tendency to develop keloids 14. Nonsteroidal anti-inflammatory or Vitamin E discontinued in the last 7-14 days 15. Platelet dysfunction syndrome 16. Thrombocytopenia less than 150,000 17. Diagnosis of hypofibrinogenemia 18. Anticipated pregnancy or trying to become pregnant in the next 2 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Improvement | 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 |
| Change in Hair Caliber Using Trichoscopy | 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. |
| Change in Hair Density Using Trichoscopy | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Qualitative Assessment of Hair Growth | Week 40 | 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 | Week 40 | 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 | Week 40 | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Platelet-rich Plasma 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. | 15 |
| 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. | 15 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
Baseline characteristics
| Characteristic | Platelet-rich Plasma Group | Placebo Group | Total |
|---|---|---|---|
| Age, Continuous | 47 years | 53 years | 50 years |
| Hair Caliber | 0.0509 mm | 0.0570 mm | 0.0540 mm |
| Hair Density | 556 hairs/cm^2 | 598 hairs/cm^2 | 577 hairs/cm^2 |
| Hair Loss | 67 months | 93 months | 80 months |
| Ludwig Score I | 8 Participants | 9 Participants | 17 Participants |
| Ludwig Score II | 6 Participants | 5 Participants | 11 Participants |
| Ludwig Score III | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Caucasian | 8 Participants | 7 Participants | 15 Participants |
| Race/Ethnicity, Customized Hispanic | 5 Participants | 7 Participants | 12 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Female | 15 Participants | 15 Participants | 30 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 / 14 | 0 / 14 |
| other Total, other adverse events | 11 / 14 | 6 / 14 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 |
Outcome results
Primary
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.
Time frame: Week 8 and 24
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Platelet-rich Plasma Group | Change in Hair Caliber Using Trichoscopy | Week 8 | 0.0043 mm | Standard Deviation 0.0024 |
| Platelet-rich Plasma Group | Change in Hair Caliber Using Trichoscopy | Week 24 | 0.0053 mm | Standard Deviation 0.0061 |
| Placebo Group | Change in Hair Caliber Using Trichoscopy | Week 8 | -0.0034 mm | Standard Deviation 0.0049 |
| Placebo Group | Change in Hair Caliber Using Trichoscopy | Week 24 | -0.0060 mm | Standard Deviation 0.0063 |
Primary
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).
Time frame: Week 8 and 24
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Platelet-rich Plasma Group | Change in Hair Density Using Trichoscopy | Week 8 | 71.1 hairs/cm^2 | Standard Deviation 40.8 |
| Platelet-rich Plasma Group | Change in Hair Density Using Trichoscopy | Week 24 | 105.9 hairs/cm^2 | Standard Deviation 102.9 |
| Placebo Group | Change in Hair Density Using Trichoscopy | Week 8 | -26.7 hairs/cm^2 | Standard Deviation 46.7 |
| Placebo Group | Change in Hair Density Using Trichoscopy | Week 24 | -52.4 hairs/cm^2 | Standard Deviation 53 |
Primary
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
Time frame: through study completion, 24 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Platelet-rich Plasma Group | Number of Participants With Improvement | 8 Participants |
| Placebo Group | Number of Participants With Improvement | 1 Participants |
Secondary
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
Time frame: Week 40
Population: Data not collected at 40 weeks.
Secondary
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.
Time frame: Week 40
Population: Data not collected
Secondary
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.
Time frame: Week 40
Population: Data not collected