The effect of sublingual minoxidil and oral dutasteride in trans people with androgenic alopecia while on testosterone

Phase 1

Active, not recruiting

• Conditions: Androgenic alopecia; Skin - Dermatological conditions

• Registration Number: ACTRN12623000356662
• Lead Sponsor: The University of Melbourne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-06
• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: Male
• Target Recruitment: 46

Inclusion Criteria

·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 Criteria

·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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Density of hairs/cm2 that are > 50 micrometers in diameter, measured using TrichoLab.[ Week 0, week 6, week 12, week 18, week 24, week 48, week 60 and week 72 post-intervention commencement.];Anagen growth rate using hair-to-hair matching from Tricholab.[ Week 0+3 days, Week 6+3 days, week 12+3 days, week 18+3 days, Week 24+3 days post-intervention commencement. ];Density of hairs/cm2 that are > 40 micrometers in diameter, measured using Tricholab.[ Week 0, Week 6, Week 12, Week 18, Week 24 post-intervention commencement.]