A Study of PRP Treatment for Hair Loss After Cancer Therapy in Women With Breast Cancer (NCT04459650) | Clinical Trial Compass
CompletedEarly Phase 1
A Study of PRP Treatment for Hair Loss After Cancer Therapy in Women With Breast Cancer
United States30 participantsStarted 2020-06-23
Plain-language summary
Participants who enroll in this study will undergo the platelet-rich plasma (PRP) study treatment. Participants will have a sample of blood collected and the platelets will be separated and then injected into half of the participants' scalp every 4 weeks for 12 weeks.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion Criteria:
* Women ≥ 18 years of age
* Have a clinical diagnosis of endocrine therapy induced alopecia (EIA) for breast cancer:
* Selective estrogen receptor modulators (tamoxifen, toremifene)
* Aromatase inhibitors (anastrozole, letrozole, exemestane)
* Gonadotropin-releasing hormone agonist (leuprolide)
OR
* Must have a clinical diagnosis of chemotherapy induced (pCIA) alopecia with incomplete or absent regrowth of hair \> 3 months after completion of chemotherapy without use of endocrine cancer-related therapy (ET) within the last 6 months
* Ludwig stage 1-3 for women
* If patient has a history of use of topical minoxidil and/or systemic spironolactone for alopecia for at least three consecutive months, then a 3 month washout is required prior to start of treatment
* Completed informed consent form
Exclusion Criteria:
* Patients who are pregnant or breastfeeding
* History of hair transplantation
* Use of any cosmetic product aimed at improving or correcting the signs of hair loss within 2weeks prior to screening. Note: patients are not permitted to use any hair loss products during the study.
* An active scalp dermatologic condition (e.g. alopecia areata, scalp psoriasis), scalp skin cancer (e.g. BCC, SCC), a pre-existing condition with sequelae on the scalp (e.g. scarring alopecia) or acute infection.
* Hereditary or acquired hematologic/coagulation disorders such as: platelet dysfunction syndrome, critical thrombocytopenia (platelet count \<150,000 p…