Category
»
Primary study
Registry of Trials»ANZCTR
Year
»
2023
INTERVENTION: Interventional group: Transgender men 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. Participants will be monitored for side effects and compliance with adherence diary. The adherence diary will be reviewed at each study visit. CONDITION: Androgenic alopecia ; ; Androgenic alopecia; Skin ‐ Dermatological conditions PRIMARY OUTCOME: 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.] Density of hairs/cm2 that are > 50 micrometers in diameter, measured using TrichoLab.[Week 0, Week 6, Week 12, Week 18, Week 24 post‐intervention commencement.] SECONDARY OUTCOME: Density of hairs/cm3 that are > 30 microns in diameter, measured using TrichoLab.[Week 0, week 6, week 12, week 18 and week 24 post‐intervention commencement.] Hair parameters from HairMetri Xthat will be assessed together as a composite primary outcome: Hair count, follicular unit type, follicular unit diameter, follicular unit diameter per cm2, medium hair by follicular count, average hair width, terminal: vellus hair ratio as well as interfollicular mean distance.[Week 0, week 6, week 12, week 18 and week 24 post intervention commencement.] Hair parameters from TrichoLab that are assessed together as composite outcome: Average number of hair per cm2, average hair shaft thickness, percentages of thin hairs, mid hairs and thick hairs, percentage of number of follicular units, percentage of empty hair follicle/yellow dots, cumulative hair thickness per cm2, number of follicular units per cm2, derived Sinclair scale and hair‐to‐hair matching in the temporal, verte Xand occipital region of the scalp. [Week 0, week 6, week 12, week 18 and week 24 post intervention commencement.] Minoxidil pharmacokinetics such as AUC and Cmax. The sample tested will be serum minoxidil level which will be collected at week 24 post‐intervention commencement.[Various time points during the day (0 hour, 0.5 hour, 1 hour, 2 hour, 4, hours, 6 hours) on the day of last visit at either Week 24 or Week 24 +3 days post intervention commencement. ] Quality of life as assessed by the Dermatology Life Quality Inde X(DLQI)[Week 0 then week 24 post‐intervention commencement.] Quality of life as assessed by the modified Women's Androgenic Alopecia Quality of Life questionnaire[Week 0 then week 24 post‐intervention commencement.] 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
Epistemonikos ID: 3002c112a2ae1d8393844044472478282d8854be
First added on: Feb 20, 2024