Clinical trial

Evaluating the Efficacy of Platelet-rich Plasma Therapy in the Treatment of Androgenic Alopecia

Name
IRB00045844
Description
The study team will assess the efficacy of platelet-rich plasma therapy, a special blood product which is from the participant's own body, in the treatment of androgenic alopecia (also known as male pattern hair loss) in females.
Trial arms
Trial start
2024-08-01
Estimated PCD
2024-11-01
Trial end
2024-12-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
Platelet-rich Plasma Left Side
Group A will receive PRP on left side of scalp and placebo (saline solution) on right side of scalp.
Arms:
Group A
Platelet-rich Plasma Right Side
Group B will receive PRP on right side of scalp and placebo (saline solution) on left side of scalp.
Arms:
Group B
Size
16
Primary endpoint
Change in Severity of Alopecia Tool (SALT) from baseline
6 months
Eligibility criteria
Inclusion Criteria: * Female ≥18 years of age at baseline visit. * Documentation of androgenic alopecia diagnosis as evidenced by one or more clinical features * Not currently on any treatment for alopecia, or has undergone 2-week washout period if recently on medication(s) for alopecia * Written informed consent obtained from subject and ability for subject to comply with the requirements of the study Exclusion Criteria: * Pregnant or breastfeeding * Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data. * Have an infection, metastatic disease or certain skin conditions (ie. Psoriasis) which could worsen or spread with injections * Diagnosed with a blood or bleeding disorder * Diagnosed with anemia * Currently on anticoagulant therapy
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': "Second offsite investigator will assess the patient for clinical improvement and will be unaware of the patient's randomization assignment.", 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 16, 'type': 'ESTIMATED'}}
Updated at
2024-05-23

1 organization

1 product

1 indication