None listed
Conditions
Brief summary
Female Pattern Hair Loss (FPHL) and Male Pattern Hair Loss (MPHL) are produced by Androgenetic Alopecia (AGA). AGA, the most common cause of hair loss in the community, is produced by androgen-mediated hair follicle miniaturization in genetically susceptible individuals. AGA can be treated medically or surgically. The most common treatment is the over-the-counter, TGA-approved topical treatment using Minoxidil lotion (2% and 5%) and 5% foam. Oral minoxidil, originally introduced in the 1970s, is TGA- and FDA-approved in doses up to 100 mg daily for treatment of refractory hypertension, malignant hypertension and for the treatment of hypertension in pregnancy. One of the commonly observed side-effects of taking Minoxidil is hypertrichosis or the condition where excessive hair growth is observed. The purpose of the study is to compare the efficacy and safety of a daily oral dose of 0.45mg minoxidil in patients diagnosed with either FPHL or MPHL. The primary aims are 1) to compare the change in hair count from first dose to end of study and 2)assess the subjective impact of hair growth and quality by completion of patient reported outcomes (PROs). This will be a single-centre, randomized, double-blind pilot study comprising 7 visits over 32 weeks followed by a 24 week open label extension period.
Interventions
24-week treatment of once a day 0.45 mg oral tablet of minoxidil including a screening visit (maximum of 28 days before first treatment) and a follow-up visit 4 weeks after last dose of study medication. Total of 32 weeks of study participation.
Adherence will be monitored through a patient diary and accountability of study medication returns at all clinic visits.
Patient blood samples will be collected and processed for safety profile (chemistry and haematology) and pharmacokinetic profiling. U
24-week treatment of once a day 0.45 mg oral tablet of minoxidil including a screening visit (maximum of 28 days before first treatment) and a follow-up visit 4 weeks after last dose of study medication. Total of 32 weeks of study participation. Adherence will be monitored through a patient diary and accountability of study medication returns at all clinic visits. Patient blood samples will be collected and processed for safety profile (chemistry and haematology) and pharmacokinetic profiling. Urinalysis including urine pregnancy testing for women of childbearing potential will be performed. Scalp skin biopsies will also be collected at Week 0 (start of treatment) and Week 24 (end of treatment. An extension part consisting of a 24-week open label treatment with either 1.35mg or 4.05mg oral minoxidil tablet following a drug holiday (minimum of 28 days) from the core study has been added. A follow-up visit 4 weeks after last dose of study medication is also included in the visit schedule. Patients who complete the core study and re-consent to extension component will be re-randomised into either the 1.35mg or the 4.05mg once daily arm. Blood samples will be collected and processed for safety profile (chemistry and haematology) and pharmacokinetic profiling. Blood samples for pharmacokinetic samplings will be collected at re-randomisation visit and Week 24 (end of treatment). Scalp skin biopsies will be collected at Week 24.
Sponsors
Prof Rodney Sinclair
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
• Clinical diagnosis of MPHL with Norwood-Hamilton Classification scores of 3(III) Vertex, 4(IV), 4(IV)a, 5(V), 5(V)a and 6 or FPHL with the Sinclair scale scores of 2 to 5. • Willing to have a temporary dot tattoo placed in the target area of the scalp • Willing to maintain the same hair style, colour, shampoo and hair products use, and approximate hair length throughout the study • Able to give informed consent • Able to comply with the study requirements for 32 consecutive weeks and the additional 24 weeks of open-label extension (OLE) period. • Completion of Part 1 of the study (for roll-over into Part 2 Extension period only).
Exclusion criteria
• exposure in the last 12 weeks prior to study commencement to : 5-alpha reductase antagonist medications (e.g., finasteride, dutasteride); anti-androgenic therapies (e.g. spironolactone, flutamide, bicalutamide, cyproterone acetate), topical or oral Minoxidil. • use of scalp hair growth products in the last 6 weeks prior to study commencement • scalp hair loss in the treatment area due to other types of hair loss, injury, disease or medical therapy. • History of hair restoration surgery. • Current participation in any other investigational drug or medical device trial, which includes administration of an investigational study medication or medical device within 3 months or 5 half-lives of the investigational product prior to study commencement • Use of anti-hypertensive medication (cardiac & renal co-morbidities) • Pregnant, planning a pregnancy or nursing a child • Participants with a history of clinically significant cardiac arrhythmia as determined by the Investigator. • Participants with clinically significant findings from medical history, clinical laboratory tests, electrocardiogram (ECG), or vital signs. • Non-compliance/non-completion of visits in Part 1 of the study
Outcome results
None listed