Hospital Universitario. Dr. José Eleuterio González
Monterrey, Nuevo León, 64460, Mexico
NCT Number: NCT05288465
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.
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Notify Me40 year and older
All sexes
Interventional
Not applicable
Monterrey, Nuevo León, 64460, Mexico
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients prescribed for Cerebrolysin treatment due neurological disease are invited to donate a scalp punch biopsy prior to and after completing the prescribed treatment.
Other names: Renacenz
Time frame: From the beginning of the treatment until 9th month.
Change in scalp pigmentation throughout cerebrolysin treatment measured by gray/white hair score.
Time frame: From the beginning of the treatment until 9th month.
Change in melanin production in the scalp measured by histochemical staining score.
Time frame: From the beginning of the treatment until 9th month.
Change in melanocyte function activity measured by immunostaining score.
Universidad Autonoma de Nuevo Leon
Other
Hair Repigmentation in Patients Undergoing on Cerebrolysin Treatment for Neurological Diseases.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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