ANZCTR - Registration

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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

8/11/2021

Date data sharing statement initially provided

8/10/2019

Date results 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

Secondary ID [1]

MINOXM001

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Androgenetic alopecia

Hair loss

Condition category

Condition code

Skin

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]

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]

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]

Part 1: Baseline, Week 8,16,24 (end of treatment) and 28 (end of study).

Primary outcome [2]

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]

Addition of timepoints for Part 2: Re-randomisation (OLE Week 0), Week 12 and 24.

Secondary outcome [1]

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]

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]

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]

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]

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]

Secondary outcome [4]

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]

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]

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]

Secondary outcome [6]

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]

Secondary outcome [7]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

Completed

Date of first participant enrolment

Anticipated

Actual

1/02/2018

Date of last participant enrolment

Anticipated

30/06/2018

Actual

17/12/2018

Date of last data collection

Anticipated

31/01/2020

Actual

31/03/2020

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment postcode(s) [1]

3000 - Melbourne

Recruitment postcode(s) [2]

3002 - East Melbourne

Recruitment postcode(s) [3]

3121 - Richmond

Recruitment postcode(s) [4]

3053 - Carlton

Recruitment postcode(s) [5]

3101 - Kew

Recruitment postcode(s) [6]

3124 - Camberwell

Recruitment postcode(s) [7]

3071 - Thornbury

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Prof Rodney Sinclair

Address [1]

Samson Clinical Pty Ltd
2/2 Wellington Parade
East Melbourne
VIC 3002

Country [1]

Australia

Funding source category [2]

Other

Name [2]

Sinclair Dermatology

Address [2]

2/2 Wellington Parade
East Melbourne
VIC 3002

Country [2]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Bellberry Limited

Ethics committee address [1]

129 Glen Osmond Road
Eastwood 
South Australia 5063

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

27/09/2017

Approval date [1]

15/01/2018

Ethics approval number [1]

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

Prof Rodney Sinclair

Address

Sinclair Dermatology
2/2 Wellington Parade
East Melbourne
VIC 3002

Country

Australia

Phone

+613 96542426

Fax

+613 96509944

[email protected]

Contact person for public queries

Name

Laita Bokhari

Address

Sinclair Dermatology
2/2 Wellington Parade
East Melbourne
VIC 3002

Country

Australia

Phone

+613 3013 0099

Fax

+613 96509944

[email protected]

Contact person for scientific queries

Name

Laita Bokhari

Address

Samson Clinical Pty Ltd
2/2 Wellington Parade
East Melbourne
VIC 3002

Country

Australia

Phone

+613 3013 0099

Fax

+613 96509944

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
2333	Informed consent form					374567-(Uploaded-13-06-2019-10-21-05)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Sublingual minoxidil for the treatment of male and female pattern hair loss: a randomized, double-blind, placebo-controlled, phase 1B clinical trial.	2022	https://dx.doi.org/10.1111/jdv.17623

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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