Hair Repigmentation During Cerebrolysin Therapy

Universidad Autonoma de Nuevo Leon

Status: Completed

Conditions: Hair Problems

Treatments: Drug: Cerebrolysin

Study type: Interventional

Funder types: Other

Identifiers

NCT05288465

NC15-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Hair repigmentation during Cerebrolysin treatment for neurological diseases

Experimental group

Description:

Patients prescribed for Cerebrolysin treatment due neurological diseases.

Treatment:

Drug: Cerebrolysin