Health Condition 1: L638- Other alopecia areata
Conditions
Interventions
Intervention1: 5% Minoxidil: 0.5 ml OD, topical for 11 hours
Control Intervention1: 5% minoxidil: 0.5 ml OD, topical for 11 hours
Sponsors
Sarvodya Medicenter
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participant able to understand and ready to provide written informed consent for participation. 2. Males aged from 18 to 50 years with male pattern baldness. 3. Consent of the participant to apply topical radiolabeled minoxidil at demarked site. 4. Consent of the participant to undergo scintigraphy imaging.
Exclusion criteria
Exclusion criteria: 1. Participant who received any hypertensive or cardiovascular medicine. 2. Participant with history of hypersensitivity to study drug or immunocompromised status. 3. Participant with a serious illness (e.g. diabetes mellitus, collagen diseases, auto-immune diseases, hematological diseases and malignant tumors); and, those with serious liver dysfunction, kidney dysfunction or cardiac problems. 4. Participant who received an investigational drug or have participated in a clinical trial within the previous 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Scalp scintigraphy images will be taken at different time points i.e. 30 min,1h,2h,4h and 8h post application of study medication to determine % scalp retention. At 8h, the demarked area will be cleaned and gamma imaging will be done to determine amount penetrated and comparative ratio will be determined.Timepoint: 30 minute, 1 hour, 2 hour, 4 hour and 8 hour | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety parameters: Physical examination, vitals, change in blood pressure and plasma sample (5ml) will be collected and analyzed for concentration of minoxidil in plasma.Timepoint: 8 hours | — |
Countries
India
Contacts
Public ContactDr Gaurav Kumar Jain
Delhi Institute of Pharmaceutical Sciences and Research
Outcome results
None listed