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

Phase 1

Completed

• Conditions: Androgenetic alopecia; Hair loss; Skin - Dermatological conditions

• Registration Number: ACTRN12618000606280
• Lead Sponsor: Prof Rodney Sinclair

Brief Summary

1.Research question: Does sublingual minoxidil improve bioavailability and promote hair growth? 2.Background information: Minoxidil lotion only promotes hair growth in 50% of androgenetic alopecia. This is because the maximal minoxidil lotion therapy is only able to produce sub-therapeutic plasma levels (less than the amount shown in the research to have an effect on hair growth, which would be increased through oral medication). Sulfotransferase converts minoxidil to minoxidil sulfate. Low sulfotransferase activity predicts poor response. 3.Participant characteristics: Men and women with androgenetic alopecia aged 30-65 years 4.Key results: Forty volunteers, aged 30-65 years, completed the initial trial. Compared to placebo, sublingual minoxidil significantly increased frontal terminal hair counts. A p-value of P = 0.035 means that this change is most likely as a result of the trial medication and not other factors. Mean peak minoxidil plasma concentrations was 1.62ng/mL. Twelve participants rolled-over into the extension phase. Dose-dependent improvement in hair counts and global photographic assessments were observed. There were no changes in blood pressure or adverse events that had any significant (as determined by the research) clinical implications or relevance for the safety of the medication. 5.Limitation: Single centre pilot study, small sample size 6.Conclusion: Sublingual minoxidil improves bioavailability and promotes hair growth.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-19
• Study Completion: 2020-03-31
• Last Update Posted: 15 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified