A 32-week randomized, placebo-controlled, double-blinded pilot study to compare the efficacy and safety of low-dose oral minoxidil in male and female patients with patterned hair loss (androgenetic alopecia) followed by a 24-week open label extension period

INTERVENTION: 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). CONDITION: Androgenetic alopecia Hair loss PRIMARY OUTCOME: To evaluate the efficacy of low‐dose oral minoxidil compared to placebo on hair density in patients with FPHL or MPHL. This will be achieved by 1) quantifying non‐vellus hair and comparing hair counts between Baseline (start of treatment) and Week 8,16,24 and 28. ; Macrophotographs of hair will be captured at Baseline, Week 8,16,24 and 28 to monitor changes or growth in the designated areas of the scalp. Quantification of hair from the macrophotographs will be carried out using an algorithm in an analysis software specific for hair quantification. Hair counts outcome between Baseline, Week 8,16,24 and 28 will be compared. SECONDARY OUTCOME: Assess the outcome of the independent investigator assessments on hair density by global photography. Independent investigator assessments of the global photographs.will be obtained and analysed. The investigator assessments is measured based on a 7‐point scale between ‐3 and +3. This coincides with a description of greatly decreased, moderately decreased, slightly decreased, no change, slightly increased, moderately increased and greatly increased respectively. Assess the subjective impact of low‐dose oral minoxidil on female participant's subjective improvement in hair growth and quality by participant's completion of the hair shedding scale questionnaire. Assess the subjective impact of low‐dose oral minoxidil on female participant's subjective improvement in hair growth and quality by the completion of the Sinclair Scale questionnaire. Assess the subjective impact of low‐dose oral minoxidil on female participant's subjective improvement in hair growth and quality by the completion of the WAA‐QOL. Assess the subjective impact of low‐dose oral minoxidil on male participant's subjective improvement in hair growth and quality by participant's completion of a modified DLQI for alopecia. Assess the subjective impact of low‐dose oral minoxidil on male participant's subjective improvement in hair growth and quality by participant's completion of MHGQ. Assess the subjective impact of low‐dose oral minoxidil on male participant's subjective improvement in hair growth and quality by participant's completion of the Kingsley Alopecia Profile Questionnaire. 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