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Completed

NCT Number: NCT05288465

Hair Repigmentation During Cerebrolysin Therapy

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario. Dr. José Eleuterio González

Monterrey, Nuevo León, 64460, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Renacenz

Primary outcomes

  1. Macroscopic evaluation of scalp repigmentation

    Time frame: From the beginning of the treatment until 9th month.

    Change in scalp pigmentation throughout cerebrolysin treatment measured by gray/white hair score.

  2. Microscopic evaluation of scalp repigmentation

    Time frame: From the beginning of the treatment until 9th month.

    Change in melanin production in the scalp measured by histochemical staining score.

  3. Evaluation of scalp melanocytes function.

    Time frame: From the beginning of the treatment until 9th month.

    Change in melanocyte function activity measured by immunostaining score.

Sponsors and collaborators

Lead sponsor

Universidad Autonoma de Nuevo Leon

Other

Collaborators

  • Hospital Universitario Dr. Jose E. Gonzalez

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Mar 21, 2022
Registry last updated
Mar 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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