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Trial registered on ANZCTR


Registration number
ACTRN12618000606280
Ethics application status
Approved
Date submitted
21/02/2018
Date registered
19/04/2018
Date last updated
5/12/2019
Date data sharing statement initially provided
8/10/2019
Date results information initially provided
8/10/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
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
Scientific title
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
Secondary ID [1] 294122 0
MINOXM001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Androgenetic alopecia 306724 0
Hair loss 306803 0
Condition category
Condition code
Skin 305824 305824 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
24-week treatment of once a day 0.45 mg oral tablet of minoxidil including a screening visit (maximum of 28 days before first treatment) and a follow-up visit 4 weeks after last dose of study medication. Total of 32 weeks of study participation.
Adherence will be monitored through a patient diary and accountability of study medication returns at all clinic visits.
Patient blood samples will be collected and processed for safety profile (chemistry and haematology) and pharmacokinetic profiling. Urinalysis including urine pregnancy testing for women of childbearing potential will be performed.
Scalp skin biopsies will also be collected at Week 0 (start of treatment) and Week 24 (end of treatment.
An extension part consisting of a 24-week open label treatment with either 1.35mg or 4.05mg oral minoxidil tablet following a drug holiday (minimum of 28 days) from the core study has been added. A follow-up visit 4 weeks after last dose of study medication is also included in the visit schedule.
Patients who complete the core study and re-consent to extension component will be re-randomised into either the 1.35mg or the 4.05mg once daily arm.
Blood samples will be collected and processed for safety profile (chemistry and haematology) and pharmacokinetic profiling. Blood samples for pharmacokinetic samplings will be collected at re-randomisation visit and Week 24 (end of treatment).
Scalp skin biopsies will be collected at Week 24.
Intervention code [1] 300406 0
Treatment: Drugs
Comparator / control treatment
Placebo group. Composition of placebo medication: Microcrystalline cellulose (Flocel) as a substitute for Minoxidil as the active ingredient.
Control group
Placebo

Outcomes
Primary outcome [1] 304888 0
To evaluate the efficacy of low-dose oral minoxidil compared to placebo on hair density in patients with FPHL or MPHL. This will be achieved by 1) quantifying non-vellus hair and comparing hair counts between Baseline (start of treatment) and Week 8,16,24 and 28. Macrophotographs of hair will be captured at Baseline, Week 8,16,24 and 28 to monitor changes or growth in the designated areas of the scalp. Quantification of hair from the macrophotographs will be carried out using an algorithm in an analysis software specific for hair quantification. Hair counts outcome between Baseline, Week 8,16,24 and 28 will be compared.
Timepoint [1] 304888 0
Part 1: Baseline, Week 8,16,24 (end of treatment) and 28 (end of study).
Primary outcome [2] 321613 0
Addition of primary outcome for part 2: To evaluate the efficacy of 2 low-dose oral minoxidil doses on hair density in patients with FPHL or MPHL. This will be achieved by 1) quantifying non-vellus hair and comparing hair counts between re-randomisation visit, Week 12 and 24. Change in number of non-vellus hair between commencement of open-label extension visit (Re-randomisation visit, OLE Week 0) to Weeks 12 and 24.
Timepoint [2] 321613 0
Addition of timepoints for Part 2: Re-randomisation (OLE Week 0), Week 12 and 24.
Secondary outcome [1] 343489 0
Assess the outcome of the independent investigator assessments on hair density by global photography. Independent investigator assessments of the global photographs.will be obtained and analysed. The investigator assessments is measured based on a 7-point scale between -3 and +3. This coincides with a description of greatly decreased, moderately decreased, slightly decreased, no change, slightly increased, moderately increased and greatly increased respectively.
Timepoint [1] 343489 0
Global photography will be conducted on Weeks 0 (Baseline,start of treatment), 8, 16, 24 (end of treatment), 28 (follow-up visit) and for Part 2 OLE at Re-randomisation visit (OLE Week 0), Weeks 4, 12 and 28. Investigator assessments will be at the same timepoints.
Secondary outcome [2] 343490 0
Assess the subjective impact of low-dose oral minoxidil on female participant's subjective improvement in hair growth and quality by participant's completion of the hair shedding scale questionnaire.
Timepoint [2] 343490 0
Questionnaires are completed on Weeks 0 (start of treatment), 8, 16, 24 (end of treatment), 28 (follow-up visit) and for Part 2 at Re-randomisation visit (OLE Week 0), Weeks 4,12, 24 and 28. Outcomes will be compiled and analysed for change,
Secondary outcome [3] 344705 0
Assess the subjective impact of low-dose oral minoxidil on male participant's subjective improvement in hair growth and quality by participant's completion of the Kingsley Alopecia Profile Questionnaire.
Timepoint [3] 344705 0
Questionnaires are completed on Weeks 0 (start of treatment), 8, 16, 24 (end of treatment), 28 (follow-up visit) and for Part 2 at Re-randomisation visit (OLE Week 0), Weeks 4,12, 24 and 28. Outcomes will be compiled and analysed for change,
Secondary outcome [4] 344706 0
Assess the subjective impact of low-dose oral minoxidil on male participant's subjective improvement in hair growth and quality by participant's completion of a modified DLQI for alopecia.
Timepoint [4] 344706 0
DLQI questionnaires are completed on Weeks 0 (start of treatment), 8, 16, 24 (end of treatment) and 28 (follow-up visit) and for Part 2 at Re-randomisation visit (OLE Week 0), Weeks 4,12, 24 and 28. Outcomes will be compiled and analysed for change,
Secondary outcome [5] 344707 0
Assess the subjective impact of low-dose oral minoxidil on male participant's subjective improvement in hair growth and quality by participant's completion of MHGQ.
Timepoint [5] 344707 0
Questionnaires are completed on Weeks 0 (start of treatment), 8, 16, 24 (end of treatment), 28 (follow-up visit) and for Part 2 at Re-randomisation visit (OLE Week 0), Weeks 4,12, 24 and 28. Outcomes will be compiled and analysed for change,
Secondary outcome [6] 344708 0
Assess the subjective impact of low-dose oral minoxidil on female participant's subjective improvement in hair growth and quality by the completion of the WAA-QOL.
Timepoint [6] 344708 0
Questionnaires are completed on Weeks 0 (start of treatment), 8, 16, 24 (end of treatment), 28 (follow-up visit) and for Part 2 at Re-randomisation visit (OLE Week 0), Weeks 4,12, 24 and 28. Outcomes will be compiled and analysed for change,
Secondary outcome [7] 344709 0
Assess the subjective impact of low-dose oral minoxidil on female participant's subjective improvement in hair growth and quality by the completion of the Sinclair Scale questionnaire.
Timepoint [7] 344709 0
Questionnaires are completed on Weeks 0 (start of treatment), 8, 16, 24 (end of treatment), 28 (follow-up visit) and for Part 2 at Re-randomisation visit (OLE Week 0), Weeks 4,12, 24 and 28. Outcomes will be compiled and analysed for change,

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
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
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Efficacy analysis will be performed on the Intent to Treat (ITT) and Per Protocol (PP) Analysis Sets. Density of hair and non-vellus hair count, as determined by macrophotography, will be assessed across treatment groups and analysed over time using ANCOVA.
Responses to the Kingsley Alopecia Profile, assessing the impact of alopecia on quality of life, will be scored for each participant and analysed using a nonparametric approach.
The DLQI, WAA-QOL, MHGQ and Investigator’s assessment of hair growth will be analysed using logistic regression dichotomizing improvement versus no change/worsening of hair condition. Exploratory analysis over the entire range of responses in the DLQI, WAA-QOL, MHGQ and Investigator’s assessment will be investigated using proportional odds ordinal regression.


Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 21613 0
3000 - Melbourne
Recruitment postcode(s) [2] 21614 0
3002 - East Melbourne
Recruitment postcode(s) [3] 21616 0
3053 - Carlton
Recruitment postcode(s) [4] 21619 0
3071 - Thornbury
Recruitment postcode(s) [5] 21617 0
3101 - Kew
Recruitment postcode(s) [6] 21615 0
3121 - Richmond
Recruitment postcode(s) [7] 21618 0
3124 - Camberwell

Funding & Sponsors
Funding source category [1] 298760 0
Self funded/Unfunded
Name [1] 298760 0
Prof Rodney Sinclair
Address [1] 298760 0
Samson Clinical Pty Ltd
2/2 Wellington Parade
East Melbourne
VIC 3002
Country [1] 298760 0
Australia
Funding source category [2] 299051 0
Other
Name [2] 299051 0
Sinclair Dermatology
Address [2] 299051 0
2/2 Wellington Parade
East Melbourne
VIC 3002
Country [2] 299051 0
Australia
Primary sponsor type
Individual
Name
Prof Rodney Sinclair
Address
Samson Clinical Pty Ltd
2/2 Wellington Parade
East Melbourne
VIC 3002
Country
Australia
Secondary sponsor category [1] 298038 0
None
Name [1] 298038 0
Address [1] 298038 0
Country [1] 298038 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299697 0
Bellberry Limited
Ethics committee address [1] 299697 0
129 Glen Osmond Road
Eastwood
South Australia 5063
Ethics committee country [1] 299697 0
Australia
Date submitted for ethics approval [1] 299697 0
27/09/2017
Approval date [1] 299697 0
15/01/2018
Ethics approval number [1] 299697 0
2017-09-669

Summary
Brief summary
Female Pattern Hair Loss (FPHL) and Male Pattern Hair Loss (MPHL) are produced by Androgenetic Alopecia (AGA). AGA, the most common cause of hair loss in the community, is produced by androgen-mediated hair follicle miniaturization in genetically susceptible individuals. AGA can be treated medically or surgically. The most common treatment is the over-the-counter, TGA-approved topical treatment using Minoxidil lotion (2% and 5%) and 5% foam. Oral minoxidil, originally introduced in the 1970s, is TGA- and FDA-approved in doses up to 100 mg daily for treatment of refractory hypertension, malignant hypertension and for the treatment of hypertension in pregnancy. One of the commonly observed side-effects of taking Minoxidil is hypertrichosis or the condition where excessive hair growth is observed. The purpose of the study is to compare the efficacy and safety of a daily oral dose of 0.45mg minoxidil in patients diagnosed with either FPHL or MPHL. The primary aims are 1) to compare the change in hair count from first dose to end of study and 2)assess the subjective impact of hair growth and quality by completion of patient reported outcomes (PROs). This will be a single-centre, randomized, double-blind pilot study comprising 7 visits over 32 weeks followed by a 24 week open label extension period.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81326 0
Prof Rodney Sinclair
Address 81326 0
Sinclair Dermatology
2/2 Wellington Parade
East Melbourne
VIC 3002
Country 81326 0
Australia
Phone 81326 0
+613 96542426
Fax 81326 0
+613 96509944
Email 81326 0
rodney.sinclair@sinclairdermatology.com.au
Contact person for public queries
Name 81327 0
Ms Laita Bokhari
Address 81327 0
Sinclair Dermatology
2/2 Wellington Parade
East Melbourne
VIC 3002
Country 81327 0
Australia
Phone 81327 0
+613 3013 0099
Fax 81327 0
+613 96509944
Email 81327 0
Laita.bokhari@sinclairdermatology.com.au
Contact person for scientific queries
Name 81328 0
Ms Laita Bokhari
Address 81328 0
Samson Clinical Pty Ltd
2/2 Wellington Parade
East Melbourne
VIC 3002
Country 81328 0
Australia
Phone 81328 0
+613 3013 0099
Fax 81328 0
+613 96509944
Email 81328 0
Laita.bokhari@sinclairdermatology.com.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?
Informed consent form
How or where can supporting documents be obtained?
Type [1] 2333 0
Informed consent form
Citation [1] 2333 0
Link [1] 2333 0
Email [1] 2333 0
Other [1] 2333 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary