Open-label histological study of scalp biopsies from patients undergoing treatment with Cerebrolysin as therapy for cerebrovascular disease. The aim is to assess by histological techniques the causes of follicular repigmentation that occurs during the Cerebrolysin treatment.
Patients who fulfill the study requirements will receive the standard Cerebrolysin protocol as follows: Intravenous (iv) infusions of 5 vials per week, 2 vials on Mondays and 3 vials on Thursdays for 4 weeks, followed by an 8-week resting period prior to the next cycle of treatment. Each patient will receive 3 cycles giving a total of 9 months of follow-up. For intravenous infusions, each 10 ml vial containing 215.2mg / ml of Cerebrolysin (Ever Pharma) is diluted with physiological saline solution (NaCI 0.9%) to a final volume of 100 mL. A pre- and post-treatment biopsies will be collected from the achromotrichia area of each patient. Antisepsis of the area will be performed prior to each biopsy with chlorhexidine, followed by local anesthesia with lidocaine 2% and epinephrine. The biopsy will be collected using a 4mm punch and the wound will be sutured with non-absorbable stitches with Prolene 4-0.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
5
Patients prescribed for Cerebrolysin treatment due neurological disease are invited to donate a scalp punch biopsy prior to and after completing the prescribed treatment.
Hospital Universitario. Dr. José Eleuterio González
Monterrey, Nuevo León, Mexico
Macroscopic evaluation of scalp repigmentation
Change in scalp pigmentation throughout cerebrolysin treatment measured by gray/white hair score.
Time frame: From the beginning of the treatment until 9th month.
Microscopic evaluation of scalp repigmentation
Change in melanin production in the scalp measured by histochemical staining score.
Time frame: From the beginning of the treatment until 9th month.
Evaluation of scalp melanocytes function.
Change in melanocyte function activity measured by immunostaining score.
Time frame: From the beginning of the treatment until 9th month.
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