Hair Repigmentation During Cerebrolysin Therapy

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Hair Repigmentation in Patients Undergoing on Cerebrolysin Treatment for Neurological Diseases.

Conditions
-----------------
Hair Problems

Intervention / Treatment
-----------------
* Drug: Cerebrolysin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Known neurologist prescription for Cerebrolysin treatment due ischemic or hemorrhagic stroke, traumatic brain injury or dementia. Age-related white or gray hair. Above 40 years old Voluntarily consents in written informed consent by the principal or legal representative Exclusion Criteria: Patients with a diagnosis of Chronic Kidney Disease (CKD). Known history of seizures, epilepsy, or hypersensitivity to one or any drug components. Pregnant patients. Patients with a history of recent treatment of hair coloring products.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: Longitudinal study of hair repigmentation in patients receiving cererbolisin treatment for neurological diseases
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hair repigmentation during Cerebrolysin treatment for neurological diseases<br>Patients prescribed for Cerebrolysin treatment due neurological diseases. | Drug: Cerebrolysin<br>* Patients prescribed for Cerebrolysin treatment due neurological disease are invited to donate a scalp punch biopsy prior to and after completing the prescribed treatment.<br>* Other names: Renacenz;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Macroscopic evaluation of scalp repigmentation | Change in scalp pigmentation throughout cerebrolysin treatment measured by gray/white hair score. | 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. | From the beginning of the treatment until 9th month. | 
| Evaluation of scalp melanocytes function. | Change in melanocyte function activity measured by immunostaining score. | From the beginning of the treatment until 9th month. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hair graying