Hair Repigmentation During Cerebrolysin Therapy

NCT05288465 | Completed

• 1 other identifier: NC15-001
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Hair Problems

Keywords

Hair graying

Outcome Measures

Primary Outcomes (3)

• 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.

Study Arms (1)

Hair repigmentation during Cerebrolysin treatment for neurological diseases

EXPERIMENTAL

Patients prescribed for Cerebrolysin treatment due neurological diseases.

Drug: Cerebrolysin

Interventions

Cerebrolysin DRUG

Patients prescribed for Cerebrolysin treatment due neurological disease are invited to donate a scalp punch biopsy prior to and after completing the prescribed treatment.

Also known as: Renacenz

Hair repigmentation during Cerebrolysin treatment for neurological diseases

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Autonoma de Nuevo Leon: lead
• Hospital Universitario Dr. Jose E. Gonzalez: collaborator

Study Sites (1)

Hospital Universitario. Dr. José Eleuterio González

Monterrey, Nuevo León, 64460, Mexico

Location

MeSH Terms

Conditions

Hair Diseases

Interventions

cerebrolysin

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Longitudinal study of hair repigmentation in patients receiving cererbolisin treatment for neurological diseases

Study Record Dates

• First Submitted: February 16, 2022
• First Posted: March 21, 2022
• Study Start: June 2, 2014
• Primary Completion: December 7, 2015
• Study Completion: December 23, 2016
• Last Updated: March 21, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)