Hair Repigmentation During Cerebrolysin Therapy
Primary Purpose
Hair Problems
Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Cerebrolysin
Sponsored by
About this trial
This is an interventional basic science trial for Hair Problems focused on measuring Hair graying
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.
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
NCT ID
NCT05288465
First Posted
February 16, 2022
Last Updated
March 10, 2022
Sponsor
Universidad Autonoma de Nuevo Leon
Collaborators
Hospital Universitario Dr. Jose E. Gonzalez
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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