Trials / Completed
CompletedNCT05288465
Hair Repigmentation During Cerebrolysin Therapy
Hair Repigmentation in Patients Undergoing on Cerebrolysin Treatment for Neurological Diseases.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 5 (actual)
- Sponsor
- Universidad Autonoma de Nuevo Leon · Academic / Other
- Sex
- All
- Age
- 40 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2014-06-02
- Primary completion
- 2015-12-07
- Completion
- 2016-12-23
- First posted
- 2022-03-21
- Last updated
- 2022-03-21
Locations
1 site across 1 country: Mexico
Source: ClinicalTrials.gov record NCT05288465. Inclusion in this directory is not an endorsement.