Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001128987
Ethics application status
Approved
Date submitted
27/10/2011
Date registered
27/10/2011
Date last updated
23/02/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
AN2728 Topical Ointment in Sensitive Areas of Healthy Volunteers
Scientific title
Local Tolerability of AN2728 Topical Ointment, 2% in Sensitive Areas in Healthy Volunteers
Secondary ID [1] 273278 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psoriasis 279043 0
Condition category
Condition code
Skin 279230 279230 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
AN2728 Topical Ointment, 2% will be applied to the specified areas (elbows, knees, groins, axillae, gluteal cleft, retroauricular areas, genitals and hairline) by the participants twice a day for 21 days.
Intervention code [1] 283623 0
Treatment: Drugs
Comparator / control treatment
Vehicle Ointment only without active ingredient.
Control group
Placebo

Outcomes
Primary outcome [1] 279859 0
To assess the systemic safety and local tolerability of AN2728 Topical Ointment, 2% and vehicle ointment in sensitive areas of healthy volunteers.
Timepoint [1] 279859 0
At baseline and at Day 3, 7, 10, 14, 17 and 22 after starting AN2728 Topical Ointment, 2% or Vehicle Ointment. The outcomes will be assessed by treatment area focused examinations by a medical officer at each timepoint. Tolerability will be assessed by grading of local tolerability symptoms such as burning/stinging, pruritis and erythema according to a scale (0=None; 1=mild; 2=moderate; 3=severe; 0.5, 1.5 are 2.5 are midpoints between the defined grades).
Secondary outcome [1] 294594 0
Nil
Timepoint [1] 294594 0
Nil

Eligibility
Key inclusion criteria
1. Ability to understand and give written informed consent prior to the initiation of any protocol-related procedures.
2. Caucasian males and females, 18-55 years (inclusive) of age at the time of randomisation.
3. Willing and able to comply with study instructions and commit to all study visits.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. History of serious adverse reactions or hypersensitivity to any drug; or known allergy to any of the test product(s) or any components in the test product(s) or history of hypersensitivity; or allergic reactions to any of the study preparations as described in the IB.
2. Any clinically significant medical conditions or history of such conditions that, in the opinion of the Investigator may place the subject at an unacceptable risk as a participant in this trial.
3. Abnormal physical findings of clinical significance or dermatological condition at the Screening examination or Baseline which would interfere with the objectives of the study.
4. Clinically significant abnormal laboratory values (as determined by the Investigator) at the Screening evaluation.
5. Chronic use of medications that would interfere with the objectives of the study (such as antihistamines, corticosteroids, analgesics and anti-inflammatories)
within 1 week of Baseline and during the study.
6. Not willing to refrain from shaving, the use of depilatories or other hair-removal activities in the treatment areas 2 days prior to enrollment and during the course of the study.
7. Not willing to refrain from all sexual contact during the treatment period and 24 h after the last dose of study drug.
8. Uncircumcised males.
9. Females who are breastfeeding or pregnant, or who intend to become pregnant during the time of their participation in the study.
10. Concurrent or recent (within 60 days of randomization) participation in another drug or device research study.
11. Considered by the Investigator to be unsuitable candidate for this study.
12. Use of AN2728 in a previous clinical trial.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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
6/11/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284109 0
Commercial sector/Industry
Name [1] 284109 0
Anacor Pharmaceuticals, Inc
Country [1] 284109 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
CMAX - A division of IDT Australia, Limited
Address
Level 5 East Wing
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 269071 0
None
Name [1] 269071 0
Address [1] 269071 0
Country [1] 269071 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 272061 0
Bellberry Limited
Ethics committee address [1] 272061 0
229 Greenhill Road
Dulwich SA 5065
Ethics committee country [1] 272061 0
Australia
Date submitted for ethics approval [1] 272061 0
28/09/2011
Approval date [1] 272061 0
26/10/2011
Ethics approval number [1] 272061 0
2011-09-463-A-1

Summary
Brief summary
The aim of this study is to assess the local tolerability of an experimental ointment called AN2728. This ointment has been tested in 11 clinical trials to date, and is being developed as a treatment for patients with psoriasis. In the laboratory this ointment has been shown to reduce inflammatory chemicals in the body that are involved in inflammatory skin diseases.
This study will help doctors find out how well people will tolerate the application of the ointment to sensitive areas in terms of any local reaction (ie. irritation, redness, itchiness). Participant's skin will be monitored closely at various times throughout the study to assess any effect that the drug has on their skin.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33317 0
Address 33317 0
Country 33317 0
Phone 33317 0
Fax 33317 0
Email 33317 0
Contact person for public queries
Name 16564 0
Louise Pirc
Address 16564 0
CMAX - A division of IDT Australia, Limited
Level 5 East Wing
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 16564 0
Australia
Phone 16564 0
+61-(0)8-8222-3923
Fax 16564 0
+61-(0)8-8223-3475
Email 16564 0
louise.pirc@cmax.com.au
Contact person for scientific queries
Name 7492 0
Sepehr Shakib
Address 7492 0
CMAX - A division of IDT Australia, Limited
Level 5 East Wing
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 7492 0
Australia
Phone 7492 0
+61-(0)8-8222-3923
Fax 7492 0
+61-(0)8-8223-3475
Email 7492 0
louise.pirc@cmax.com.au

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.