Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000356662
Ethics application status
Approved
Date submitted
20/03/2023
Date registered
6/04/2023
Date last updated
14/06/2024
Date data sharing statement initially provided
6/04/2023
Date results information initially provided
14/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of sublingual minoxidil and oral dutasteride in trans people with androgenic alopecia while on testosterone
Scientific title
The effect of low-dose sublingual minoxidil and oral dutasteride in transgender and gender-diverse individuals assigned female at birth with androgenic alopecia while on testosterone.

Secondary ID [1] 308714 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record
Nil known

Health condition
Health condition(s) or problem(s) studied:
Androgenic alopecia
 328647 0
Condition category
Condition code
Skin 325659 325659 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study goes from week 0 to week 72. It will consist of 3 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.
Part 3: A double-blinded, randomised, placebo-controlled clinical trial assessing participants on sublingual minoxidil with oral dutasteride vs sublingual minoxidil with placebo from week 49 to week 72.

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.

From week 48 to week 72, participants will continue to be on 2.50mg sublingual minoxidil twice a day. They will be randomised to then receive either oral placebo, 1 capsule daily, or 0.50mg dutasteride capsule daily.

Participants will be monitored for side effects and compliance and will be requested to fill out side-effects survey at each study visit.
Intervention code [1] 325174 0
Treatment: Drugs
Comparator / control treatment
The control group will be transmasculine individuals on testosterone therapy experiencing some degree of androgenic alopecia, receiving sublingual placebo tablets made up of sweetened polyethylene glycols, from week 0 to week 24 post randomisation.

From week 49 to week 72 post randomisation, the control group will be transmasculine individuals on testosterone therapy receiving sublingual minoxidil in addition to oral placebo made up of Flocel.
Control group
Placebo

Outcomes
Primary outcome [1] 333503 0
Density of hairs/cm2 that are > 50 micrometers in diameter, measured using TrichoLab.
Timepoint [1] 333503 0
Week 0, week 6, week 12, week 18, week 24, week 48, week 60 and week 72 post-intervention commencement.
Primary outcome [2] 333506 0
Anagen growth rate using hair-to-hair matching from Tricholab.
Timepoint [2] 333506 0
Week 0+3 days, Week 6+3 days, week 12+3 days, week 18+3 days, Week 24+3 days post-intervention commencement.
Primary outcome [3] 334265 0
Density of hairs/cm2 that are > 40 micrometers in diameter, measured using Tricholab.
Timepoint [3] 334265 0
Week 0, Week 6, Week 12, Week 18, Week 24 post-intervention commencement.
Secondary outcome [1] 417310 0
Quality of life as assessed by the modified Women's Androgenic Alopecia Quality of Life questionnaire
Timepoint [1] 417310 0
Week 0, week 12, week 24, week 48, week 60 and week 72 post commencement.
Secondary outcome [2] 417311 0
Quality of life as assessed by the Dermatology Life Quality Index (DLQI)
Timepoint [2] 417311 0
Week 0, week 12, week 24, week 48, week 60 and week 72 post-intervention commencement.
Secondary outcome [3] 420050 0
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, vertex and occipital region of the scalp.
Timepoint [3] 420050 0
Week 0, week 12, week 24, week 48, week 60 and week 72 post-intervention commencement.
Secondary outcome [4] 420051 0
Hair parameters from HairMetrix that 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.
Timepoint [4] 420051 0
Week 0, week 24 post-intervention commencement and week 12, week 48, week 60 and week 72 (optional if logistically possible).
Secondary outcome [5] 420052 0
Density of hairs/cm2 that are >30, >60, >70 and >80 microns in diameter, measured using TrichoLab
Timepoint [5] 420052 0
Week 0, week 12, week 24, week 48, week 60 and week 72 post-intervention.
Secondary outcome [6] 429112 0
Assessing patient satisfaction with male hair growth questionnaire (MHGQ)
Timepoint [6] 429112 0
Week 12, week 24, week 48, week 60 and week 72 post-intervention.
Secondary outcome [7] 429113 0
Assessing patient satisfaction with male hair growth questionnaire (MHGQ)
Timepoint [7] 429113 0
Week 12, week 24, week 60 and week 72 post-intervention commencement.
Secondary outcome [8] 429114 0
7-point scale assessment of global photograph by blinded assessor panel
Timepoint [8] 429114 0
Week 24, week 48 and week 72 post-intervention commencement.
Secondary outcome [9] 429116 0
7-point scale assessment of global photograph by participant
Timepoint [9] 429116 0
Week 0, week 24, week 48 and week 72 post-intervention commencement.
Secondary outcome [10] 436392 0
Transmasculine sexual function index questionnaire.
Timepoint [10] 436392 0
Secondary outcome [11] 436393 0
Transmasculine sexual function index questionnaire.
Timepoint [11] 436393 0
Week 24, week 48, week 60 and week 72 post-intervention commencement

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involves contacting the holder of the allocation schedule located "off-site" for dispensing of medication.

Batches of generic tablets which will either be compounded minoxidil or placebo (sugared propylene glycol) in small screw top containers numbered according to the randomisation sequence. Each numbered container will hold identical-looking tablets filled with either minoxidil or placebo. This is then given in the order of recruitment.

Participants from week 25 to week 48 will be given sublingual minoxidil. No placebo.
From week 49 to week 72, participants continue to be on sublingual minoxidil but are then randomised to receive either oral placebo (Flocel) or oral 0.50mg dutasteride capsule daily.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation sequence will be generated electronically by computer software by a third person not directly involved in the study.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
This is both a parallel and single group study.

Week 0 to week 24: Parallel (sublingual minoxidil vs sublingual placebo)
Week 25 to week 48: Single group (all participants receive sublingual minoxidil)
Week 49 to week 72: Parallel (participants receive sublingual minoxidil + oral placebo vs sublinfual minoxidil vs oral dutasteride)
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Based on an unpublished study (Asfour, Kasprzak, Sinclair) assessing hairs that are clinically significant i.e. 50 micron in size or larger, with those on minoxidil 1.35mg achieving mean 15.8 hairs/cm2 compared with placebo group achieving mean -8.4 with standard deviation 21.4, a sample size of 13 per group is required (power 0.8 and level of significance 0.05). Based on a conservative drop-out rate of 20% (other longitudinal studies conducted in transgender individuals have a dropout rate of ~10-15%), it is estimated that a total of 32 participants will be required for enrolment into the study to be powered, to show a difference in terminal hair density between groups.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/06/2023
Actual
4/09/2023
Date of last participant enrolment
Anticipated
5/04/2024
Actual
22/01/2024
Date of last data collection
Anticipated
20/06/2025
Actual
Sample size
Target
32
Accrual to date
Final
46
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 39862 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 312937 0
University
Name [1] 312937 0
The University of Melbourne
Country [1] 312937 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Parkville VIC, 3010
Australia
Country
Australia
Secondary sponsor category [1] 315208 0
None
Name [1] 315208 0
Address [1] 315208 0
Country [1] 315208 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312210 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 312210 0
145 Studley Rd, Heidelberg VIC 3084
Ethics committee country [1] 312210 0
Australia
Date submitted for ethics approval [1] 312210 0
16/02/2023
Approval date [1] 312210 0
18/05/2023
Ethics approval number [1] 312210 0
HREC/94183/Austin-2023

Summary
Brief 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.
Trial website
https://www.transresearch.org.au/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123858 0
A/Prof Ada Cheung
Address 123858 0
Austin Health
145 Studley Rd, Heidelberg VIC 3084
Country 123858 0
Australia
Phone 123858 0
+61 4033 11850
Fax 123858 0
Email 123858 0
adac@unimelb.edu.au
Contact person for public queries
Name 123859 0
A/Prof Ada Cheung
Address 123859 0
Austin Health
145 Studley Rd, Heidelberg VIC 3084
Country 123859 0
Australia
Phone 123859 0
+61 4033 11850
Fax 123859 0
Email 123859 0
adac@unimelb.edu.au
Contact person for scientific queries
Name 123860 0
Dr Gia Tang
Address 123860 0
Austin Health
145 Studley Rd, Heidelberg VIC 3084
Country 123860 0
Australia
Phone 123860 0
+61 4511 59118
Fax 123860 0
Email 123860 0
giat@student.unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD may include identifiable patient data so this will not be shared.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.