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Hair Repigmentation During Cerebrolysin Therapy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05288465
Enrollment
5
Registered
2022-03-21
Start date
2014-06-02
Completion date
2016-12-23
Last updated
2022-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hair Problems

Keywords

Hair graying

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.

Interventions

DRUGCerebrolysin

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

Sponsors

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

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Macroscopic evaluation of scalp repigmentationFrom 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 repigmentationFrom 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.

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026