Hair Repigmentation During Cerebrolysin Therapy

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

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.

Study Overview

• Status: Completed
• Conditions: Hair Problems
• Intervention / Treatment: Drug: Cerebrolysin

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 Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Nuevo Leon
    • Monterrey, Nuevo Leon, Mexico, 64460
      • Hospital Universitario. Dr. José Eleuterio González

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hair repigmentation during Cerebrolysin treatment for neurological diseases; Patients prescribed for Cerebrolysin treatment due neurological diseases.	Drug: Cerebrolysin; 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

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.

Collaborators and Investigators

• Sponsor: Universidad Autonoma de Nuevo Leon
• Collaborators: Hospital Universitario Dr. Jose E. Gonzalez

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2014
• Primary Completion (Actual): December 7, 2015
• Study Completion (Actual): December 23, 2016

Study Registration Dates

• First Submitted: February 16, 2022
• First Submitted That Met QC Criteria: March 10, 2022
• First Posted (Actual): March 21, 2022

Study Record Updates

• Last Update Posted (Actual): March 21, 2022
• Last Update Submitted That Met QC Criteria: March 10, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Hair graying
• Additional Relevant MeSH Terms: Skin Diseases; Hair Diseases; Physiological Effects of Drugs; Neuroprotective Agents; Protective Agents; Nootropic Agents; Cerebrolysin
• Other Study ID Numbers: NC15-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No