Hair Repigmentation During Cerebrolysin Therapy

Sponsor

Universidad Autonoma de Nuevo Leon (Other)

Overall Status

Completed

CT.gov ID

NCT05288465

Collaborator

Hospital Universitario Dr. Jose E. Gonzalez (Other)

Enrollment

Location

Arm

30.7

Actual Duration (Months)

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hair Problems	Drug: Cerebrolysin	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

5 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Longitudinal study of hair repigmentation in patients receiving cererbolisin treatment for neurological diseasesLongitudinal study of hair repigmentation in patients receiving cererbolisin treatment for neurological diseases

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Jun 2, 2014

Actual Primary Completion Date :

Dec 7, 2015

Actual Study Completion Date :

Dec 23, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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.
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.
Evaluation of scalp melanocytes function. [From the beginning of the treatment until 9th month.]
Change in melanocyte function activity measured by immunostaining score.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Universitario. Dr. José Eleuterio González	Monterrey	Nuevo Leon	Mexico	64460

Sponsors and Collaborators

Universidad Autonoma de Nuevo Leon
Hospital Universitario Dr. Jose E. Gonzalez

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Roberto Montes de Oca Luna, Principal Investigator, Universidad Autonoma de Nuevo Leon

ClinicalTrials.gov Identifier:

NCT05288465

Other Study ID Numbers:

NC15-001

First Posted:

Mar 21, 2022

Last Update Posted:

Mar 21, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Roberto Montes de Oca Luna, Principal Investigator, Universidad Autonoma de Nuevo Leon

Hair graying

Additional relevant MeSH terms:

Hair Diseases

Cerebrolysin

Study Results

No Results Posted as of Mar 21, 2022