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Hair Repigmentation During Cerebrolysin Therapy

Primary Purpose

Hair Problems

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Cerebrolysin
Sponsored by
Universidad Autonoma de Nuevo Leon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hair Problems focused on measuring Hair graying

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hospital Universitario. Dr. José Eleuterio González

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hair repigmentation during Cerebrolysin treatment for neurological diseases

Arm Description

Patients prescribed for Cerebrolysin treatment due neurological diseases.

Outcomes

Primary Outcome Measures

Macroscopic evaluation of scalp repigmentation
Change in scalp pigmentation throughout cerebrolysin treatment measured by gray/white hair score.
Microscopic evaluation of scalp repigmentation
Change in melanin production in the scalp measured by histochemical staining score.
Evaluation of scalp melanocytes function.
Change in melanocyte function activity measured by immunostaining score.

Secondary Outcome Measures

Full Information

First Posted
February 16, 2022
Last Updated
March 10, 2022
Sponsor
Universidad Autonoma de Nuevo Leon
Collaborators
Hospital Universitario Dr. Jose E. Gonzalez
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1. Study Identification

Unique Protocol Identification Number
NCT05288465
Brief Title
Hair Repigmentation During Cerebrolysin Therapy
Official Title
Hair Repigmentation in Patients Undergoing on Cerebrolysin Treatment for Neurological Diseases.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
June 2, 2014 (Actual)
Primary Completion Date
December 7, 2015 (Actual)
Study Completion Date
December 23, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Autonoma de Nuevo Leon
Collaborators
Hospital Universitario Dr. Jose E. Gonzalez

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hair Problems
Keywords
Hair graying

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Longitudinal study of hair repigmentation in patients receiving cererbolisin treatment for neurological diseases
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hair repigmentation during Cerebrolysin treatment for neurological diseases
Arm Type
Experimental
Arm Description
Patients prescribed for Cerebrolysin treatment due neurological diseases.
Intervention Type
Drug
Intervention Name(s)
Cerebrolysin
Other Intervention Name(s)
Renacenz
Intervention Description
Patients prescribed for Cerebrolysin treatment due neurological disease are invited to donate a scalp punch biopsy prior to and after completing the prescribed treatment.
Primary Outcome Measure Information:
Title
Macroscopic evaluation of scalp repigmentation
Description
Change in scalp pigmentation throughout cerebrolysin treatment measured by gray/white hair score.
Time Frame
From the beginning of the treatment until 9th month.
Title
Microscopic evaluation of scalp repigmentation
Description
Change in melanin production in the scalp measured by histochemical staining score.
Time Frame
From the beginning of the treatment until 9th month.
Title
Evaluation of scalp melanocytes function.
Description
Change in melanocyte function activity measured by immunostaining score.
Time Frame
From the beginning of the treatment until 9th month.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Hospital Universitario. Dr. José Eleuterio González
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64460
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No

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Hair Repigmentation During Cerebrolysin Therapy

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