The Effect of Platelet Rich Plasma on Non-scarring Alopecia
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|ClinicalTrials.gov Identifier: NCT03689452|
Recruitment Status : Completed
First Posted : September 28, 2018
Last Update Posted : June 25, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Androgenetic Alopecia Alopecia||Device: Platelet Rich Plasma Drug: Normal saline||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||The Effect of Platelet Rich Plasma on Non-scarring Alopecia|
|Actual Study Start Date :||October 1, 2018|
|Actual Primary Completion Date :||June 3, 2019|
|Actual Study Completion Date :||June 3, 2019|
Placebo Comparator: Control
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.
Drug: Normal saline
Preservative-free normal saline will be used as described in arm/group description section.
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.
Device: Platelet 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.
- Qualitative assessment of hair growth using photography [ Time Frame: Week 40 ]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.
- Assessment of the change in hair caliber using trichoscopy [ Time Frame: Week 40 ]Trichoscopy is a microscope used to assess hair. This will be used to measure hair caliber in millimeters.
- Assessment of the change in hair density using trichoscopy [ Time Frame: Week 40 ]Trichoscopy is a microscope used to assess hair. This will be used to measure hair density (number of hairs in a square centimeter of scalp).
- Qualitative assessment of hair growth [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03689452
|United States, New York|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10028|
|Principal Investigator:||Hooman Khorasani, MD||Icahn School of Medicine at Mount Sinai|