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Trial registered on ANZCTR


Registration number
ACTRN12613000974707
Ethics application status
Approved
Date submitted
2/08/2013
Date registered
2/09/2013
Date last updated
3/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
A Single-Center, Randomized, Double-Blind, Placebo Controlled Study of the Safety, Tolerability and Pharmacokinetics of Various Concentrations of Topical SM04554 Solution in Male Subjects with Androgenetic Alopecia.
Scientific title
A Single-Center, Randomized, Double-Blind, Placebo Controlled Study of the Safety, Tolerability and Pharmacokinetics of Various Concentrations of Topical SM04554 Solution in Male Subjects with Androgenetic Alopecia
Secondary ID [1] 282879 0
'Nil Known'
Universal Trial Number (UTN)
U1111-1145-8758
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Androgenetic Alopecia 289698 0
Condition category
Condition code
Skin 290021 290021 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study drug is a topical SM04554 solution. SM04554 is a small molecule that may activate the wnt pathway. The dosage amounts are: 0.05%; 0.15%; and 0.45%. Administration of the study drug will be once daily for 14 days at the study clinic; study drug is applied topically to the scalp. There are three cohorts of 10 participants. Cohort 1 will be administered the 0.05% solution, Cohort 2 will be administered the 0.15% solution and Cohort 3 will be administered the 0.45% solution. Participants will complete a series of tests prior to the start of the study. During the study the participants’ scalp will be assessed by the study doctor on a daily basis and prior to administration of the study drug. Hair growth assessments will also be completed by the study doctor and the participant 1 day following the completion of the treatment and 14 days following completion of the treatment.
Intervention code [1] 287582 0
Treatment: Drugs
Comparator / control treatment
The placebo is a topical solution (polyethylene glycol)
Control group
Placebo

Outcomes
Primary outcome [1] 290068 0

To characterize the safety and tolerability of topical SM04554 solution (0.05%, 0.15% and 0.45%) applied to the scalp of male subjects with Androgenetic Alopecia. This is assessed by the following:
1. Collection of adverse events following the first administration of the study drug and up until Day 28 (14 days post the final administration of the study drug);
2. Non fasting clinical laboratory analysis of Chemistry, Haematology and urinalysis during the screening visit and on the 14th day of treatment and 14 days following the end of the treatment;
3. Collection of Vital Signs each day of treatment;
4. Daily assessment of the participants’ scalp each day prior to treatment.
5. ECG at screening, Day 1 and Day 14, prior to treatment and 4 hours after treatment.
Timepoint [1] 290068 0
Day 1 to Day 14.
Secondary outcome [1] 303886 0
To characterize the pharmacokinetics (PK) of topical SM04554 solution (0.05%, 0.15%, 0.45%) applied to the scalp of male subjects with AGA
Timepoint [1] 303886 0
PK samples will be taken on Day 1 and 2 and on Day 14 and 15 at the following timepoints:
Pre dose; and at 1,2,4,6,9,12 and 24 hours post dose.
Secondary outcome [2] 304324 0
To assess hair growth and quality based upon questionnaires completed by the physician and subject.
Timepoint [2] 304324 0
Hair growth will be assessed by the PI using an 'Investigator assessment scale' at Day 15 and Day 28.
Hair growth will be assessed by the subject using a 'subject assessment of hair growth' questionnaire at Day 15 and Day 28. Scalp photography will be taken prior to study drug administration and then again at Day 15 and 28.

Eligibility
Key inclusion criteria
Males between 18 and 60 years of age, inclusive
Diagnosed with androgenetic (AGA) alopecia with a Norwood-Hamilton Classification score of 4, 5, 6 or 7.
In good general health
Willing and able to attend study visits
Willing to maintain same hair style for the duration of the study
Willing to use a sponsor supplied shampoo and conditioner for the duration of the study
Able to comprehend and willing to sign an informed consent form
Minimum age
18 Years
Maximum age
60 Years
Gender
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Clinical diagnosis of alopecia areata or other non-AGA form of alopecia.
Scalp hair loss, on the treatment area, due to disease, injury or medical therapy.
Males who are sexually active and have a partner that is capable of becoming pregnant, neither of which have had surgery to become sterilized, who are not using an effective method of birth control (e.g., surgically implanted hormonal therapy, intrauterine devices or oral birth control with barrier method).
Current skin disease (e.g., psoriasis, atopic dermatitis, skin cancer, eczema, sun damage, seborrheic dermatitis), cuts and or abrasions on the scalp or condition (e.g., sunburn, tattoos) on the treatment area that, in the opinion of the investigator, might put the subject at risk or interfere with the study conduct or evaluations.
History of surgical correction of hair loss on the scalp.
Use of finasteride or dutasteride within the 12 weeks prior to the Screening Visit.
Use of minoxidil within the 12 weeks prior to the Screening Visit.
Use of anti-androgenic therapies (e.g., spironolactone, flutamide, cyperoterone acetate, cimetidine) within 12 weeks prior to the Screening Visit.
Use of any scalp hair growth products within the 12 weeks prior to the Screening Visit.
History of hair transplants.
Current use of an occlusive wig, hair extensions or hair weaves
History of hypersensitivity or allergies to any ingredient of the study medications.
Participation in any other investigational drug trial in which administration of an investigational study medication occurred within 30 days prior to the Screening Visit.
Poor peripheral venous access.
Subjects with a history of clinically significant cardiac arrhythmia as determined by the principal investigator.
Subjects with clinically significant findings from medical history, clinical laboratory tests, ECG and vital signs that, in the opinion of the investigator, could interfere with the objectives of the study or put the subject at risk.

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)
Subjects will attend a screening visit. If they meet the inclusion criteria and none of the exclusion criteria then they will be deemed by the investigator to be eligible to enter the study. The investigator and study staff with the exception of the pharmacist are blinded to the study treatment. A randomisation list computer generated and is provided by the sponsor to the pharmacist who is unblinded. Blinded study personnel will assign subject number sequentially.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Type of endpoint(s)
Safety
Statistical methods / analysis

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
Recruitment postcode(s) [1] 7188 0
4006 - Herston

Funding & Sponsors
Funding source category [1] 287667 0
Commercial sector/Industry
Name [1] 287667 0
Samumed LLC
Address [1] 287667 0
9381 Judicial Dr, Suite 160
San Diego, CA 92121
Country [1] 287667 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Samumed LLC
Address
9381 Judicial Dr, Suite 160
San Diego, CA 92121
Country
United States of America
Secondary sponsor category [1] 286403 0
Commercial sector/Industry
Name [1] 286403 0
Novotech (Australia) Pty Ltd
Address [1] 286403 0
Level 3, 235 Pyrmont Street
Pyrmont, NSW 2009
Country [1] 286403 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289631 0
Queensland Institute of Medical Research HREC
Ethics committee address [1] 289631 0
300 Herston Road
Herston QLD 4006
Ethics committee country [1] 289631 0
Australia
Date submitted for ethics approval [1] 289631 0
22/07/2013
Approval date [1] 289631 0
23/08/2013
Ethics approval number [1] 289631 0

Summary
Brief summary
The main purpose of this study is to assess how safe and how well a topical solution, which is applied to the scalp of male participants who have a condition called male pattern baldness is tolerated. The secondary purpose is to assess how effective the topical solution is and also to assess the way the body absorbs, distributes and gets rid of the drug SM04554.

.
Trial website
Trial related presentations / publications
NA
Public notes

Contacts
Principal investigator
Name 41638 0
Dr Lauren Kunde
Address 41638 0
Q-Pharm Pty Ltd
300C Herston Road
Herston QLD 4006
Country 41638 0
Australia
Phone 41638 0
61 7 3845 3636
Fax 41638 0
Email 41638 0
L.Kunde@qpharm.com.au
Contact person for public queries
Name 41639 0
Mr Brian McHale
Address 41639 0
Q-Pharm Pty Ltd
300C Herston Road
Herston QLD 4006
Country 41639 0
Australia
Phone 41639 0
61 7 3845 3636
Fax 41639 0
Email 41639 0
S.Rankine@qpharm.com.au
Contact person for scientific queries
Name 41640 0
Dr Yusuf Yazici
Address 41640 0
Samumed LLC
9381 Judicial Drive
Suite 160
San Diego, CA 92121
Country 41640 0
United States of America
Phone 41640 0
1 858 926 2900
Fax 41640 0
Email 41640 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