Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000689077
Ethics application status
Approved
Date submitted
19/08/2010
Date registered
20/08/2010
Date last updated
29/11/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised, double-blind, placebo controlled study to assess efficacy of oral nicotinamide (500mg daily) in the treatment and prevention of actinic keratoses.
Scientific title
Effect of nicotinamide versus placebo on numbers of actinic keratoses
Secondary ID [1] 252515 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Actinic keratoses 258004 0
Condition category
Condition code
Skin 258173 258173 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oral nicotinamide 500mg daily for four months
Intervention code [1] 257049 0
Treatment: Drugs
Comparator / control treatment
Placebo tablets (lactose tablets idetical in appearance and size to nicotinamide tablets but without active ingredient) daily for four months.
Control group
Placebo

Outcomes
Primary outcome [1] 259034 0
Reduction in total actinic keratosis (AK) count at 2 and 4 months from baseline
Timepoint [1] 259034 0
2 and 4 months
Secondary outcome [1] 265295 0
Nil
Timepoint [1] 265295 0
Nil

Eligibility
Key inclusion criteria
Men and women > 18 years old.
Symmetrically distributed non-hyperkeratotic AKs on face / scalp/ upper limbs.
Minimum of 4 AKs in one or more treatment areas.
Patients have received no other treatments for AKs within the last month.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Under 18 years old
Pregnant or lactating
Taking immunosuppressive or photosensitising medications
Immune suppressive concurrent illness (eg, human immunodeficiency virus- HIV- infection)
Malignancy (excluding nonmelanoma skin cancer) in the previous 5 years
Taking nicotinamide supplements within the last month
Patients unable to attend for regular follow up
Patients with active dermatitis in assessment areas
Liver disease (although hepatic effects of nicotinamide are rare, in contrast to nicotinic acid)
Currently taking carbamazepine (case reports of interaction with nicotinamide)

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)
Sequentially numbered bottles (ie, numbered containers) will be randomised at source with patients and observers blinded to assignment. The person determing whether a subject is eligible for inclusion in the trial will be unaware, when this decision is made, as to which group the subject would be allocated. The randomisation code will be unbroken until the final patient completes the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Unstratified, randomised blocks
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/08/2010
Actual
1/09/2010
Date of last participant enrolment
Anticipated
Actual
1/03/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257497 0
Charities/Societies/Foundations
Name [1] 257497 0
Cancer Council NSW
Country [1] 257497 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital
Address
Sydney South West Area Health Service (SSWAHS) Ethics Committee
Level 3 Building 92
Royal Prince Alfred Hospital
Missenden Rd
Camperdown 2050
Country
Australia
Secondary sponsor category [1] 256729 0
Individual
Name [1] 256729 0
Diona Damian
Address [1] 256729 0
Dermatology Gloucester House Level 3 Royal Prince Alfred Hospital Missenden Rd Camperdown 2050
Country [1] 256729 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259524 0
Sydney South West Area Health Service (SSWAHS) Ethics Committee
Ethics committee address [1] 259524 0
Ethics committee country [1] 259524 0
Australia
Date submitted for ethics approval [1] 259524 0
Approval date [1] 259524 0
09/08/2010
Ethics approval number [1] 259524 0
09/RPAH/2

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

Contacts
Principal investigator
Name 31546 0
Prof Diona Damian
Address 31546 0
Dermatology, GH3 Royal Prince Alfred Hospital Camperdown NSW 2050
Country 31546 0
Australia
Phone 31546 0
+612 9515 8295
Fax 31546 0
+612 9565 1048
Email 31546 0
[email protected]
Contact person for public queries
Name 14793 0
Diona Damian
Address 14793 0
Dermatology Gloucester House Level 3 Royal Prince Alfred Hospital Missenden Rd Camperdown 2050
Country 14793 0
Australia
Phone 14793 0
612 9515 8295
Fax 14793 0
612 9565 1048
Email 14793 0
[email protected]
Contact person for scientific queries
Name 5721 0
Diona Damian
Address 5721 0
Dermatology Gloucester House Level 3 Royal Prince Alfred Hospital Missenden Rd Camperdown 2050
Country 5721 0
Australia
Phone 5721 0
612 9515 8295
Fax 5721 0
612 9565 1048
Email 5721 0
[email protected]

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
SourceTitleYear of PublicationDOI
Dimensions AIOral Nicotinamide Reduces Actinic Keratoses in Phase II Double-Blinded Randomized Controlled Trials2012https://doi.org/10.1038/jid.2011.459
N.B. These documents automatically identified may not have been verified by the study sponsor.