Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001356550
Ethics application status
Approved
Date submitted
5/12/2015
Date registered
15/12/2015
Date last updated
28/06/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
A prospective study comparing topical corticosteroids with a combination of topical corticosteroids plus the trial agent (TA) in morphea.
Scientific title
Assessing the response of limited scleroderma to manipulation of
the kynurenine pathway. A prospective study comparing topical
corticosteroids vs topical corticosteroids/tranilast
Secondary ID [1] 288072 0
Nil
Universal Trial Number (UTN)
U1111-1177-3064
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
MORPHEA 296943 0
Condition category
Condition code
Skin 297189 297189 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cross body trial of topical betamethasone valerate 0.1% vs topical betamethasone valerate 0.1% and tranilast 1% applied twice daily over a period of 3 months. Monitoring is to be done monthly via LoSCAT scores, laboratory tests and cream return. All other prescribed therapy is to be continued. The dosage of both agents is one finger tip unit (0.5g) per hand sized region (125 sqcm)
Intervention code [1] 293390 0
Treatment: Drugs
Comparator / control treatment
Topical betamethasone valerate 0.1% (active control) applied twice daily over a period of 3 months.
Control group
Active

Outcomes
Primary outcome [1] 296794 0
The Localized Scleroderma Cutaneous Assessment Tool (LoSCAT) score
Timepoint [1] 296794 0
3 months after commencing therapy
Secondary outcome [1] 319375 0
Therapeutic safety is to be monitored via clinical review and laboratory testing
Timepoint [1] 319375 0
Assessment is performed at monthly intervals after commecing therapy for a period of 3 months.

Eligibility
Key inclusion criteria
Adults with morphea greater than 18 yrs of age
Non pregnant
Non lactating
No significant renal, hematological or hepatic disease
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Less than 18 yrs of age
Pregnant or lactating females
Known sensitivity to the trial agent
Significant renal, hematological or hepatic disease

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)
Central randomization by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised 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
Other
Other design features
Randomized double blinded split body study with betamethasone valerate 0.1% applied at one site and betamethasone valerate o.1% , tranilast 1% applied to a contralateral site
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The staistical parameters used to determine the number of participants are:
Alpha value. 0.05
Power 90
Size effect 0.7
Statistical significance p< 0.05

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/12/2015
Date of last participant enrolment
Anticipated
31/12/2018
Actual
27/02/2017
Date of last data collection
Anticipated
1/06/2017
Actual
22/06/2017
Sample size
Target
11
Accrual to date
Final
11
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 4853 0
Greenslopes Private Hospital - Greenslopes
Recruitment postcode(s) [1] 12353 0
4120 - Greenslopes

Funding & Sponsors
Funding source category [1] 292508 0
Self funded/Unfunded
Name [1] 292508 0
DR ROWLAND NOAKES
Country [1] 292508 0
Australia
Primary sponsor type
Individual
Name
DR ROWLAND NOAKES
Address
QUEENSLAND INSTITUTE OF DERMATOLOGY
GREENSLOPES PRIVATE HOSPITAL
GREENSLOPES QLD 4120
Country
Australia
Secondary sponsor category [1] 291217 0
None
Name [1] 291217 0
Address [1] 291217 0
Country [1] 291217 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293983 0
GREENSLOPES RESEARCH AND ETHICS COMMITTEE
Ethics committee address [1] 293983 0
GREENSLOPES PRIVATE HOSPITAL
NEWDEGATE STREET
GREENSLOPES. QLD 4120
Ethics committee country [1] 293983 0
Australia
Date submitted for ethics approval [1] 293983 0
08/12/2014
Approval date [1] 293983 0
14/10/2015
Ethics approval number [1] 293983 0
PROTOCOL14/70

Summary
Brief summary
This is a cross body trial to compare the safety and efficacy of topical tranilast in morphea. This agent is an established pharmaceutical with a good safety record which has been available in Japan and Korea for 20-30 yrs but has never been marketed in Australia. It has approval for the management of keloid and hypertrophic scars in these countries. There are publshed reports of efficacy in morphea.

The trial involves the application of a corticosteroid cream to one involved site on the body with the application of a cream containing both corticosteroid and the trial agent at an alternate site for a period of 3 months. Monthly clinical and laboratory assessments will be performed over this time. All currently prescribed treatments will be continued during this period.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61970 0
Dr ROWLAND NOAKES
Address 61970 0
QUEENSLAND INSTITUTE OF DERMATOLOGY
GREENSLOPES PRIVATE HOSPITAL
GREENSLOPES QLD 4120
Country 61970 0
Australia
Phone 61970 0
+61733294400
Fax 61970 0
+61733294455
Email 61970 0
ky_n_urenine@hotmail.com
Contact person for public queries
Name 61971 0
Mrs ANGELA BOND
Address 61971 0
QUEENSLAND INSTITUTE OF DERMATOLOGY
GREENSLOPES PRIVATE HOSPITAL
GREENSLOPES QLD 4120
Country 61971 0
Australia
Phone 61971 0
+61733294400
Fax 61971 0
+61733294455
Email 61971 0
abond@qiderm.com.au
Contact person for scientific queries
Name 61972 0
Dr ROWLAND NOAKES
Address 61972 0
QUEENSLAND INSTITUTE OF DERMATOLOGY
GREENSLOPES PRIVATE HOSPITAL
GREENSLOPES QLD 4120
Country 61972 0
Australia
Phone 61972 0
+61733294400
Fax 61972 0
+61733294455
Email 61972 0
ky_n_urenine@hotmail.com

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.