Hair Repigmentation During Cerebrolysin Therapy

Not Applicable

Completed

• Conditions: Hair Problems
• Interventions: Drug: Cerebrolysin

• Registration Number: NCT05288465
• Lead Sponsor: Universidad Autonoma de Nuevo Leon

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.

Study Timeline

• Study Start: 2014-06-02
• Primary Completion: 2015-12-07
• Study Completion: 2016-12-23
• Study First Submitted: 2022-02-16
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-10
• Last Update Submitted: 2022-03-10
• Study First Posted: 2022-03-21
• Last Update Posted: 2022-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hair repigmentation during Cerebrolysin treatment for neurological diseases	Cerebrolysin	Patients prescribed for Cerebrolysin treatment due neurological diseases.

Primary Outcome Measures

Name	Time	Method
Evaluation of scalp melanocytes function.	From the beginning of the treatment until 9th month.	Change in melanocyte function activity measured by immunostaining score.
Microscopic evaluation of scalp repigmentation	From the beginning of the treatment until 9th month.	Change in melanin production in the scalp measured by histochemical staining score.
Macroscopic evaluation of scalp repigmentation	From the beginning of the treatment until 9th month.	Change in scalp pigmentation throughout cerebrolysin treatment measured by gray/white hair score.

Trial Locations

Locations (1)

Hospital Universitario. Dr. José Eleuterio González; 🇲🇽 Monterrey, Nuevo Leon, Mexico