Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000369628
Ethics application status
Approved
Date submitted
2/09/2005
Date registered
13/09/2005
Date last updated
13/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Double-Blind, Randomised, Single Centre, Placebo-Controlled Phase II Study to Evaluate the Safety and Efficacy of a Single Subcutaneous Implant of EPT 1647 in Patients Suffering from Recurrent Polymorphous Light Eruption
Scientific title
A Double-Blind, Randomised, Single Centre, Placebo-Controlled Phase II Study to Evaluate the Safety and Efficacy of a Single Subcutaneous Implant of EPT 1647 in Patients Suffering from Recurrent Polymorphous Light Eruption
Universal Trial Number (UTN)
Trial acronym
EP012
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Polymorphous Light Eruption (PMLE) 464 0
Condition category
Condition code
Skin 541 541 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
EPT1647 - 6 months
Intervention code [1] 342 0
Prevention
Comparator / control treatment
Control group
Placebo

Outcomes
Primary outcome [1] 632 0
To determine whether EPT 1647 implants given as a prophylactic can prevent or reduce the occurrence of symptoms like urticaria, vesiculation, papules, eczema, erithema, itching and burning associated with PMLE
Timepoint [1] 632 0
Reviewed at each monthly visit
Secondary outcome [1] 1306 0
To establish the safety and tolerability as judged from observed Adverse Events, of a sustained release implant of EPT 1647 delivering approximately 20 mg over a 10 day period in Caucasian participants with a history of recurrent Polymorphous Light Eruption (PMLE).
Timepoint [1] 1306 0
Over 6 months

Eligibility
Key inclusion criteria
History of PMLE.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
History of skin cancer.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed code break envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generated by Random.org which uses atmospheric noises to randomisation numbers. The sequence is completely random therefore no restriction method was used.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
12/09/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 599 0
Commercial sector/Industry
Name [1] 599 0
Epitan Limited
Country [1] 599 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Epitan Limited
Address
Country
Australia
Secondary sponsor category [1] 488 0
None
Name [1] 488 0
N/A
Address [1] 488 0
Country [1] 488 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 36198 0
Address 36198 0
Country 36198 0
Phone 36198 0
Fax 36198 0
Email 36198 0
Contact person for public queries
Name 9531 0
Dr Chris Baker and Dr Peter Foley
Address 9531 0
St Vincents Hospital
Melbourne VIC 3065
Country 9531 0
Australia
Phone 9531 0
+61 3 92882211
Fax 9531 0
Email 9531 0
baker.c@bigpond.com
Contact person for scientific queries
Name 459 0
Dr Chris Baker and Dr Peter Foley
Address 459 0
St Vincents Hospital
Melbourne VIC 3065
Country 459 0
Australia
Phone 459 0
+61 3 92882211
Fax 459 0
Email 459 0
baker.c@bigpond.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.