Alopecia
Conditions
Interventions
This is a randomized controlled clinical study, with two arms, double blind, with a split scalp design in which each participant acts as his own control. Thirty participants with Androgenetic Alopecia
Sponsors
Universidade Federal de São Paulo
Associação Beneficente de Coleta de Sangue - Colsan
Eligibility
Sex/Gender
Male
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Participants aged 18 to 65 years. Male gender. With Androgenetic Alopecia (AGA). Normal serum levels of Thyroid-Stimulating Hormone (TSH), Free Thyroxine (Free T4), Iron, Ferritin, Transferrin Saturation, and Complete Blood Count to rule out telogen effluvium. Agreement with the study conditions. Ability to understand and strictly follow the given instructions. Availability to attend periodic follow-up evaluations. Signing of the Informed Consent Form (ICF) and the Photography Authorization Form
Exclusion criteria
Exclusion criteria: Use of topical Minoxidil; oral Minoxidil, or oral Finasteride in the last three months. Performance of any cosmetic procedures on the scalp in the last six months (e.g., microneedling, intradermal drug infusion). Hematologic coagulation disorders, anticoagulant therapy, use of antiplatelet agents, thyroid deficiency, dermatologic disorders, or systemic diseases that contribute to hair loss. Unrealistic expectations. Severe systemic diseases or use of systemic corticosteroids or immunosuppressants. Scalp diseases presenting the Koebner phenomenon. Allergy to tattoo dye. Allergy to Lidocaine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to find an increase in the density of terminal hairs per square centimeter in the treated areas compared with the control areas, verified through standardized digital phototrichogram, by observing a positive variation in the number of hairs classified as terminal, defined as those with a diameter greater than 0.03 millimeters, between the pre and post intervention measurements | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to observe a global clinical improvement of hair, verified through a five point scale applied in blinded evaluation based on standardized photographs, by identifying the scores assigned by the study participant, by the principal investigator, and by two independent dermatologists, considering one as much worse and five as much better;It is expected to identify an improvement in dermatology related quality of life, verified through the application of the Dermatology Life Quality Index Brazilian Version before and after treatment, by observing a favorable variation in the scores obtained in both assessments;It is expected to identify differences in the expression of immunohistochemical markers and in histological changes between the treated areas and the control areas, verified through specific immunohistochemical analyses and histological staining, by observing the expression of CD31 for angiogenesis, C KIT for cellular proliferation, KI 67 as a proliferation marker, and hematoxylin and eosin staining for general histological assessment;It is expected to identify an increase in patient satisfaction with the treatment, verified through self assessment of the perceived results on each side of the scalp using a five point scale, by observing the scores assigned by the participant considering one as much worse and five as much better;It is expected to observe an improvement in the clinical response to treatment according to the investigator’s opinion, verified through visual comparison of standardized photographs obtained before and after treatment using a five point scale, by identifying the scores assigned by the investigator considering one as much worse and five as much better ;It is expected to identify the maintenance of results three months after the last application, verified through the assessment of the persistence of the therapeutic effects of Platelet Rich Plasma compared with saline solution after completion of the protocol, by observing the | — |
Countries
Brazil
Contacts
Public ContactGabriel Cortez
Universidade Federal de São Paulo
Outcome results
None listed