Hair Repigmentation During Cerebrolysin Therapy

What Was Tested

In this not phased trial, researchers set out to test Cerebrolysin.

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.

It had 1 arm (groups): Hair repigmentation during Cerebrolysin treatment for neurological diseases (experimental).

Patients prescribed for Cerebrolysin treatment due neurological diseases.

The registry classes the interventions as drug.

More on the Plan

Each patient will receive 3 cycles giving a total of 9 months of follow-up.

A pre- and post-treatment biopsies will be collected from the achromotrichia area of each patient.

The biopsy will be collected using a 4mm punch and the wound will be sutured with non-absorbable stitches with Prolene 4-0.

Who Took Part

Enrollment: 5 actual participants took part.

It was open to people of any sex aged from 40 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: patients with a diagnosis of chronic kidney disease (ckd); known history of seizures, epilepsy, or hypersensitivity to one or any drug components; pregnant patients.

How the Study Was Run

It was run as a single-group and open-label study.

Nothing was hidden in this open-label Cerebrolysin study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2014-06-02 with completion listed for 2015-12-07.

It ran at 1 site in Mexico.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Macroscopic evaluation of scalp repigmentation (time frame: From the beginning of the treatment until 9th month). Microscopic evaluation of scalp repigmentation (time frame: From the beginning of the treatment until 9th month). Evaluation of scalp melanocytes function (time frame: From the beginning of the treatment until 9th month).

What This Means in Plain Language

Put simply, this is a not phased trial of Cerebrolysin in 5 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cerebrolysin compound page, all human trials.