The effect of sublingual minoxidil in trans people with androgenic alopecia receiving testosterone for gender-affirmation
The effect of low-dose sublingual minoxidil in transgender and gender-diverse individuals assigned female at birth with androgenic alopecia while on testosterone for gender-affirmation
The University of Melbourne
32 participants
Sep 4, 2023
Interventional
Conditions
Summary
Transgender men on testosterone therapy may experience hair loss as a side effect, which can be distressing as it may not align with their gender expression. There are limited data as to what can be used to minimise hair loss in trans men. Minoxidil is approved to treat hair loss in cisgender population in topical form. The oral form has been used off-label in the cisgender population to treat hair loss as well. This study is conducted in a randomised, double-blinded manner using the sublingual form of minoxidil to see whether or not it will regrow hair on the scalp that can provide cosmetic significance and minimise distress. Furthermore, extension studies are done to assess sublingual minoxidil as a monotherapy and combined therapy. This can improve the quality of life for transgender individuals.
Eligibility
Inclusion Criteria6
- · Adults assigned female at birth, and over 18 years of age
- · Currently on standard dose of testosterone therapy
- · Experiencing scalp hair loss likely to be androgenic alopecia
- · Willing and able to attend all study visits at week 0, 6, 12, 18 and 24 and comply with treatment plan and required study procedures
- · Able to comply with the titration schedule of dispensed medications
- · Willing to have temporary 1mm tattoos on their scalp
Exclusion Criteria14
- · Known pre-existing hair diseases, pre-existing conditions that are poorly managed and can influence or interfere with hair growth/appearance (e.g., thyroid disorders, psoriasis, eczema, seborrhoeic dermatitis) as deemed appropriate by the investigators
- · Previous treatments for hair loss e.g., finasteride/dutasteride, spironolactone, flutamide, bicalutamide, cyproterone acetate, topical or oral minoxidil within 12 weeks prior to treatment visit 1
- · Use of scalp hair growth products (e.g. ketoconazole shampoo, topical prostaglandin or prostanoid treatment, aminexil, nioxin, Fusion Hair 101, platelet rich plasma injections, low-level LED light treatment) during the study or within 6 weeks prior to treatment visit 1
- · History of hair restoration surgery
- · Current use of occlusive wig, hair extensions, or hair weaves that might interfere with assessment of response.
- · Unwilling to comply with all study procedures and assessments
- · Pregnant, planning a pregnancy or nursing a child.
- · Absolute and relative contraindications to minoxidil:
- a. Known hypersensitivity to the drug or its components (e.g. propylene glycol),
- b. Phaeochromocytoma
- c. Pregnant or breastfeeding
- d. Known history of cerebrovascular disease
- e. Pre-existing pulmonary hypertension
- f. Chronic congestive heart failure
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Interventions
The study goes from week 0 to week 48. It will consist of 2 parts: Part 1: A double-blinded, randomised, placebo-controlled clinical trial comparing sublingual minoxidil and placebo from week 0 to week 24 Part 2: A prospective observational study where all participants will receive sublingual minoxidil from week 25 to week 48. Interventional group: Transgender and gender-diverse individuals who are already on testosterone therapy (regardless of duration) will receive titration sublingual minoxidil tablets from week 0 to endpoint week 24. The starting dose will be 0.45mg twice a day for 2 weeks from week 0 post randomisation, then 0.9mg twice a day for the next 2 weeks (week 2-3) then 1.35mg twice a day onward (from week 4) to week 24. From week 24 to week 72, all participants will continue on sublingual minoxidil but at a different dose. The starting dose will be 0.45mg twice a day for 3 days, 0.90mg twice a day for 3 days, 1.35mg twice a day for 3 days, 1.80mg twice a day for 3 days and then 2.50mg twice a day onward to week 48. Participants will be monitored for side effects and compliance and will be requested to fill out side-effects survey at each study visit.
Locations(1)
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ACTRN12623000356662