Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000027415
Ethics application status
Not yet submitted
Date submitted
8/01/2007
Date registered
11/01/2007
Date last updated
11/01/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigation into the treatment of Female Pattern Hair Loss
Scientific title
Double blind placebo controlled trial into the the treatment of female pattern hair loss with spironolactone and minoxidil.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Female Pattern Hair Loss 1526 0
Condition category
Condition code
Other 1622 1622 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
2 randomly allocated intervention groups:
spironolactone and topical placebo treatment
sprionolactone and topical minoxidil

spironolactone will be admisnistered at a dose of 200mg once daily orally and 2% topical minoxidil will be used as 1ml bd topical
the duration of treatment is 12 months
Intervention code [1] 1535 0
Treatment: Drugs
Comparator / control treatment
1 randomly allocated control group: placebo tablet and and topical placebo
Control group
Placebo

Outcomes
Primary outcome [1] 2239 0
Hair counts
Timepoint [1] 2239 0
Measured before commencement of treatment and at 6 monthly intervals
Secondary outcome [1] 3903 0
Midscalp clinical grading system
Timepoint [1] 3903 0
Measurements taken before initial treatment and at 6 monthly intervals.
Secondary outcome [2] 3904 0
Patient self evaluation of hair density
Timepoint [2] 3904 0
Measurements taken before initial treatment and at 6 monthly intervals.

Eligibility
Key inclusion criteria
Diffuse hair loss of greater than 6 months, with at clinical diagnosis of female pattern hair loss-Biopsy proven follicle miniaturization (terminal/villus = 4:1).-Treatment naïve.
Minimum age
18 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Contraindications to minoxidil or spironolactone-other causes of hair loss.

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 concealment using central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random order generation using simple randomisation by using a randomization table created by a computer software (i.e., computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
both subjects and researchers are blinded to allocation
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1769 0
Government body
Name [1] 1769 0
NHMRC
Country [1] 1769 0
Australia
Primary sponsor type
Individual
Name
Prof Rodney Sinclair, Head of Department of Dermatology, St Vincent's Hospital, Melbourne
Address
Country
Australia
Secondary sponsor category [1] 1574 0
None
Name [1] 1574 0
n/a
Address [1] 1574 0
Country [1] 1574 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 3305 0
St Vincent's Hospital Melbourne
Ethics committee address [1] 3305 0
Ethics committee country [1] 3305 0
Australia
Date submitted for ethics approval [1] 3305 0
Approval date [1] 3305 0
Ethics approval number [1] 3305 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27469 0
Address 27469 0
Country 27469 0
Phone 27469 0
Fax 27469 0
Email 27469 0
Contact person for public queries
Name 10724 0
Dr Anosha Yazdabadi
Address 10724 0
Department of Dermatology
St Vincent's Hospital
Fitzroy
Country 10724 0
Australia
Phone 10724 0
(03) 9288 2211
Fax 10724 0
Email 10724 0
[email protected]
Contact person for scientific queries
Name 1652 0
Prof Rodney Sinclair
Address 1652 0
Department of Dermatology
St Vincent's Hospital
Fitzroy
Victoria
Country 1652 0
Australia
Phone 1652 0
(03) 9288 3293
Fax 1652 0
Email 1652 0
[email protected]

No information has been provided regarding IPD availability


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.