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Trial registered on ANZCTR


Registration number
ACTRN12615000980538
Ethics application status
Approved
Date submitted
13/07/2015
Date registered
18/09/2015
Date last updated
16/05/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
A single-center study of the safety, tolerability and pharmacokinetics of a single concentration of topical SM04554 (0.25% concentration) solution in male subjects with androgenetic alopecia.
Scientific title
A phase I study to investigate the pharmacokinetics, safety and tolerability of topical applied 0.25% solution of SM04554 in male subjects with androgenetic alopecia.
Secondary ID [1] 286953 0
NIL
Universal Trial Number (UTN)
U1111-1171-3976
Trial acronym
None
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Androgenetic alopecia (AGA) 295402 0
Condition category
Condition code
Skin 295660 295660 0 0
Dermatological conditions
Metabolic and Endocrine 296396 296396 0 0
Other endocrine disorders
Human Genetics and Inherited Disorders 296397 296397 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Daily topical application of 0.25% (w/v) solution of SM04554 to scalp for 14 days.
SM04554 is supplied as in a non-aqueous solution of PEG400 at concentration of 0.25% weight per volume (w/v);1 vial of 0.5mL
Subject will apply at least 0.3mL of a 0.5mL study drug (SM04554) at site during visits under supervision of site staff.
Intervention code [1] 292180 0
Treatment: Drugs
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 295393 0
To characterise pharmacokinetics of topically applied 0.25% SM04554 solution to male subjects with androgenetic alopecia, estimated using available concentration-time data for Cmax, tmax, AUC (0-24), AUC (0-infinite time) and t(1/2) from collected blood samples.
Timepoint [1] 295393 0
On treatment days 1 and 14 blood samples will be taken prior to study drug application and at 1, 2, 4, 6, 12 and 24 hours post study drug application.

On treatment days 5 and 10 blood samples will be taken prior to study drug application only.
Secondary outcome [1] 315503 0
To characterise safety and tolerability of topical SM04554 0.25% solution to scalp of male subjects with androgenetic alopecia as determined by changes from baseline in vital signs, clinical laboratory parameters and electrocardiography(ECG)
Timepoint [1] 315503 0
ECG: days 1 and 14 prior and 4 hour post study treatment
Vital signs: screening day, days 1, to 14 prior to study treatment, on days 1 and 14 at 4 and 12 hours post study treatment. ECG also performed at follow up visit day 15.
Clinical chemistry, haematology parameters and urinalysis: screening day and day 14 prior to study treatment and day 15 post study treatment
Secondary outcome [2] 316245 0
To characterise safety and tolerability of topical SM04554 0.25% solution to scalp of male subjects with androgenetic alopecia as determined by adverse events (such as skin irritation (erythema,scaling puritis, stinging) , eye irritation) and assessed by medically qualified study staff.
Timepoint [2] 316245 0
Every day from first day study drug application to day 14 and at end of study day 15.
Secondary outcome [3] 316246 0
To characterise safety and tolerability of topical SM04554 0.25% solution to scalp of male subjects with androgenetic alopecia as determined by investigator skin assessment of the scalp and hands.
Timepoint [3] 316246 0
Treatment days 1 to 14 prior to study drug application and on follow up visit day 15.

Eligibility
Key inclusion criteria
Males with clinical diagnosis of AGA with Norwood classification score of 5, 5A, 5V or 6
Wiling to maintain hairstyle, use indicated shampoo & conditioner and not use semi-permanent hair products
Willing to inform female partners to avoid direct contact as potential effects to a foetus is unknown
Able to understand and willing to sign informed consent form
Minimum age
18 Years
Maximum age
65 Years
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Clinical diagnosis alopecia areata or other non-AGA forms of alopecia
Scalp hair loss on treatment area due to disease, injury or medical therapy
Current skin disease on treatment area or hands
History of surgical correction for hair loss on scalp and or hair transplant
Use of any products or devices clinically proven to promote hair loss within 24 weeks prior to Screening visit
Use of anti-androgenic therapies within 12 weeks prior to Screening visit
Previous exposure to SM04554
Use of semi-permanent hair products with 30 days prior to screening
Use medicated shampoo&conditioner or OTC hair treatments of dandruff or promotion of hair growth within 30 days prior to screening
Current use of an occlusive wig, hair extensions or hair weaves
History of hypersensitivity or allergies to any ingredient of study drug
Poor peripheral venous access
History clinically significant cardiac arrhythmia
Unwilling to refrain form sperm donations
Participation in another drug or device clinical study within 30 days or 5 half lives of the investigational agent prior to screening
Subjects with pregnant partners at screening visit

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Study is not randomised
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Single group
Other design features
none
Phase
Phase 1
Type of endpoint(s)
Pharmacokinetics
Statistical methods / analysis
Sample size of approximately 20 is selected based upon precedent set by other PK studies of similar nature and not based on power calculation.
The safety analysis set includes all subjects who received a least one treatment and PK analysis set will include subjects who complied with all study procedures.
PK parameters of SM04554 will be estimated using available concentration-time data and summarised with descriptive statistics. PK will be estimated for both safety and PK analysis sets

Recruitment
Recruitment status
Completed
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)
QLD

Funding & Sponsors
Funding source category [1] 291532 0
Commercial sector/Industry
Name [1] 291532 0
Samumed Pacific Pty Ltd
Address [1] 291532 0
Unit 16 Lakeside Corporate
24 Parkland Road
Osbourne Park, WA 6017
Australia
Country [1] 291532 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Samumed Pacific Pty Ltd
Address
Unit 16 Lakeside Corporate
24 Parkland Road
Osbourne Park, WA 6017
Australia
Country
Australia
Secondary sponsor category [1] 290263 0
None
Name [1] 290263 0
Address [1] 290263 0
Country [1] 290263 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293074 0
QIMR Berghofer Medical Research Institute HREC
Ethics committee address [1] 293074 0
300 Herston Rd,
Herston, Queensland 4006
Ethics committee country [1] 293074 0
Australia
Date submitted for ethics approval [1] 293074 0
16/06/2014
Approval date [1] 293074 0
17/07/2014
Ethics approval number [1] 293074 0
P2060

Summary
Brief summary
Androgenetic Alopecia (AGA) which is also known as male patern baldness is a common form of hair loss in both men and women. Samumed Company is developing SM04554 for the treatment of AGA. SM04554 is a small molecule which activates proteins involved in maintaining hair growth
The purpose of this study is to learn more about the safety and activity of a SM04554. This study drug is a solution to be rubbed onto the scalp once every day for 14 days. To obtain information on the how the body absorbs distributes and removes the drug form the body (pharmacokinetics), blood samples will be taken to measure the concentration of the study drug over the 14 days of application. This study will also check safety by measuring heart, liver and kidney function, number of blood cells, vital signs and scalp assessments.
Trial website
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 58262 0
Dr Casey Rowe
Address 58262 0
Level 5, Clive Berghofer Cancer Research Centre
300 Herston Road
Herston QLD 4006
Country 58262 0
Australia
Phone 58262 0
+61 7 3845 3636
Fax 58262 0
Email 58262 0
C.Rowe@qpharm.com.au
Contact person for public queries
Name 58263 0
Dr Yusuf Yazici
Address 58263 0
Samumed, LLC
9381 Judicial Dr, Suite 160
San Diego, CA 92121
Country 58263 0
United States of America
Phone 58263 0
+1 858 926 2926
Fax 58263 0
+1 858 926 9315
Email 58263 0
yusuf@samumed.com
Contact person for scientific queries
Name 58264 0
Dr Yusuf Yazici
Address 58264 0
Samumed, LLC
9381 Judicial Dr, Suite 160
San Diego, CA 92121
Country 58264 0
United States of America
Phone 58264 0
+1 858 926 2926
Fax 58264 0
+1 858 552 9315
Email 58264 0
yusuf@samumed.com

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary