Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000370606
Ethics application status
Approved
Date submitted
3/09/2005
Date registered
13/09/2005
Date last updated
22/10/2021
Date data sharing statement initially provided
22/10/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Double-Blind, Randomised, Placebo-Controlled Study to Evaluate the Photoprotective Effect of a Sustained Release dose of Melanotan in Fair skinned Healthy Caucasians
Scientific title
A Double-Blind, Randomised, Placebo-Controlled Study to Evaluate the Photoprotective Effect of a Sustained Release dose of Melanotan in Fair skinned Healthy Caucasians
Universal Trial Number (UTN)
Trial acronym
EP008
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sunburn 465 0
Condition category
Condition code
Skin 542 542 0 0
Normal skin development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
EPT 1647 - 3 months
Intervention code [1] 345 0
Prevention
Comparator / control treatment
Control group
Placebo

Outcomes
Primary outcome [1] 633 0
To compare erythemal response 24hr post solar-stimulated irradiation in Melanotan-treated and placebo-treated individuals
Timepoint [1] 633 0
At 4, 8 and 12 weeks after initiation of dosing
Secondary outcome [1] 1307 0
To compare the incidence of DNA damage (thymine dimers) elicited 30 minutes after controlled solar irradiation (3x MED) to a small area of buttock skin (1 x 1 cm).
Timepoint [1] 1307 0
At baseline and 8 weeks after initiation of dosing with Melanotan or placebo.

Eligibility
Key inclusion criteria
Healthy Caucasian men and women.
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)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Computer software SAS was used for the random allocation sequence and the blocking restriction method was used.
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/06/2006
Actual
10/06/2005
Date of last participant enrolment
Anticipated
Actual
12/09/2005
Date of last data collection
Anticipated
Actual
6/12/2005
Sample size
Target
48
Accrual to date
Final
45
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 600 0
Commercial sector/Industry
Name [1] 600 0
Epitan Limited
Country [1] 600 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Epitan Limited
Address
Level 13, 1 Collins Street
Melbourne, VIC, 3000
AUSTRALIA
Country
Australia
Secondary sponsor category [1] 489 0
None
Name [1] 489 0
N/A
Address [1] 489 0
Country [1] 489 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 35773 0
Address 35773 0
Country 35773 0
Phone 35773 0
Fax 35773 0
Email 35773 0
Contact person for public queries
Name 9534 0
Prof R Barnetson
Address 9534 0
Royal Prince Alfred Hospital
Missenden Road
Camperdown
NSW 2050
Country 9534 0
Australia
Phone 9534 0
02 9515 6111
Fax 9534 0
Email 9534 0
[email protected]
Contact person for scientific queries
Name 462 0
Dr V Pua
Address 462 0
Royal Prince Alfred Hospital
Missenden Road
Camperdown
NSW 2050
Country 462 0
Australia
Phone 462 0
02 9515 6111
Fax 462 0
Email 462 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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.