Hair ProblemsNCT05288465
Hair Repigmentation During Cerebrolysin Therapy
A study testing Cerebrolysin in people with Hair Problems, run by Universidad Autonoma de Nuevo Leon at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Hair Problems
- What is being tested?
- Cerebrolysin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteMexico
- Study dates
- 2 Jun 2014to 23 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Universitario. Dr. José Eleuterio González
Monterrey, Nuevo León, 64460
About this study
Official title: Hair Repigmentation in Patients Undergoing on Cerebrolysin Treatment for Neurological Diseases.
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.
Read the 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.
- Conditions
- Hair Problems
- Being tested
- Cerebrolysin
- Keywords
- Hair graying
- Medical subject headings
- Hair Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CerebrolysinDrug
Also called Renacenz
Patients prescribed for Cerebrolysin treatment due neurological disease are invited to donate a scalp punch biopsy prior to and after completing the prescribed treatment.
| Study group | Role | What they receive |
|---|---|---|
| Hair repigmentation during Cerebrolysin treatment for neurological diseases | Experimental | Patients prescribed for Cerebrolysin treatment due neurological diseases. Receives: Drug: Cerebrolysin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macroscopic evaluation of scalp repigmentation
Change in scalp pigmentation throughout cerebrolysin treatment measured by gray/white hair score.
Measured: 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.
Measured: From the beginning of the treatment until 9th month.
Evaluation of scalp melanocytes function.
Change in melanocyte function activity measured by immunostaining score.
Measured: From the beginning of the treatment until 9th month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start2 Jun 2014
- Primary completion7 Dec 2015
- Study completion23 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hair ProblemsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Longitudinal study of hair repigmentation in patients receiving cererbolisin treatment for neurological diseases
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Nuevo Leon
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario Dr. Jose E. Gonzalez
- Responsible party
- Principal investigator, Roberto Montes de Oca Luna, Universidad Autonoma de Nuevo Leon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05288465
- Sponsor's protocol ID
- NC15-001
- Status last verified
- Mar 2022
- First submitted
- 16 Feb 2022
- Last updated
- 21 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hair Repigmentation in Patients Undergoing on Cerebrolysin Treatment for Neurological Diseases.
- ClinicalTrials.gov ID
- NCT05288465
- Acronym / sponsor ID
- NC15-001
- Conditions
- Hair Problems
- Keywords
- Hair graying
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Universidad Autonoma de Nuevo LeonUniversity, hospital or other
- Collaborators
- Hospital Universitario Dr. Jose E. Gonzalez
- Study start
- 2 Jun 2014 (actual)
- Primary completion
- 7 Dec 2015 (actual)
- Study completion
- 23 Dec 2016 (actual)
- First posted
- 21 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Longitudinal study of hair repigmentation in patients receiving cererbolisin treatment for neurological diseases
| Arm | Type | Receives |
|---|---|---|
| Hair repigmentation during Cerebrolysin treatment for neurological diseases | Experimental | Drug: CerebrolysinPatients prescribed for Cerebrolysin treatment due neurological diseases. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CerebrolysinAlso: RenacenzPatients prescribed for Cerebrolysin treatment due neurological disease are invited to donate a scalp punch biopsy prior to and after completing the prescribed treatment. | Drug | Hair repigmentation during Cerebrolysin treatment for neurological diseases |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cerebrolysin in people with Hair Problems, run by Universidad Autonoma de Nuevo Leon at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Macroscopic evaluation of scalp repigmentation (time frame: From the beginning of the treatment until 9th month.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2022; AzTrials last refreshed its copy on 1 Nov 2026.