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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

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Trial registered on ANZCTR


Registration number
ACTRN12609000490279
Ethics application status
Approved
Date submitted
13/05/2009
Date registered
19/06/2009
Date last updated
19/06/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomised, double-blind, placebo controlled study to assess efficacy of oral nicotinamide in the treatment and prevention of actinic keratoses
Scientific title
Randomised, double-blind, placebo controlled study to assess efficacy of oral nicotinamide in the treatment and prevention of actinic keratoses
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Actinic Keratoses 4707 0
Condition category
Condition code
Skin 5023 5023 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Administration of 500 mg nicotinamide tablet compared to placebo twice daily for four months.
Intervention code [1] 4471 0
Prevention
Comparator / control treatment
Placebo tablet made of lactose. The dose, frequency and duration of treatment are the same as for nicotinamide group (i.e. 500mg twice a day for 4 months).
Control group
Placebo

Outcomes
Primary outcome [1] 5864 0
Reduction in total actinic keratosis count at 4 months compared with baseline count. This primary outcome will be assesed by blinded clinical examination by a medically qualified observer.
Timepoint [1] 5864 0
Actinic Keratosis count at baseline and 4 months
Secondary outcome [1] 241895 0
Reduction in site specific (i.e. face, arms,scalp) actinic keratosis count at 2 and 4 months compared with baseline count. The secondary outcome will be assessed in the same way as the primary outcome (i.e. blinded clinical examination by a medically qualified observer).
Timepoint [1] 241895 0
Actinic keratosis count at baseline and 2 months

Eligibility
Key inclusion criteria
Symmetrically distributed non-hyperkeratotic actinic keratoses on face/ scalp/ upper limbs. Minimum of 4 actinic keratoses in one or more treatment areas. Patients have received no other treatments for actinic keratoses within the last month.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant or lactating. Taking immunosuppressive or photosensitizing medications. Taking nicotinamide or other vitamin supplements. Patients unable to attend for regular follow up. Patients with active dermatitis in the treatment areas. Liver disease. Currently taking Carbamazepine.

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)
Volunteers will be randomized to receive either nicotinamide 500 mg tablet twice daily or placebo. Both active treatment and placebo will be contained within identical containers. Allocation will be concealed within sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated random sequence will be used without any restrictions
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

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

Funding & Sponsors
Funding source category [1] 4885 0
Hospital
Name [1] 4885 0
Royal Prince Alfred (provides infrastructural support)
Country [1] 4885 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred (provide infrastructural support)
Address
Missenden Rd, Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 4661 0
None
Name [1] 4661 0
Address [1] 4661 0
Country [1] 4661 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6950 0
Sydney South West Area Health Service ethics comittee
Ethics committee address [1] 6950 0
Ethics committee country [1] 6950 0
Australia
Date submitted for ethics approval [1] 6950 0
Approval date [1] 6950 0
Ethics approval number [1] 6950 0
X-09 00004
HREC/09/RPAH/2

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

Contacts
Principal investigator
Name 29558 0
Address 29558 0
Country 29558 0
Phone 29558 0
Fax 29558 0
Email 29558 0
Contact person for public queries
Name 12805 0
Associate Professor Diona Damian
Address 12805 0
Department of Dermatology
Level 3
Gloucester House
Royal Prince Alfred Hospital
Missenden Rd, Camperdown, NSW 2050
Country 12805 0
Australia
Phone 12805 0
+61 2 95158295
Fax 12805 0
+61 2 95651048
Email 12805 0
diona.damian@email.cs.nsw.gov.au
Contact person for scientific queries
Name 3733 0
Associate Professor Diona Damian
Address 3733 0
Department of Dermatology
Level 3
Gloucester House
Royal Prince Alfred Hospital
Missenden Rd, Camperdown, NSW 2050
Country 3733 0
Australia
Phone 3733 0
+61 2 95158295
Fax 3733 0
+61 2 95651048
Email 3733 0
diona.damian@email.cs.nsw.gov.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
SourceTitleYear of PublicationDOI
Dimensions AIOral Nicotinamide Reduces Actinic Keratoses in Phase II Double-Blinded Randomized Controlled Trials2012https://doi.org/10.1038/jid.2011.459
EmbaseAn update on clinical trials for chemoprevention of human skin cancer.2023https://dx.doi.org/10.20517/2394-4722.2022.99
N.B. These documents automatically identified may not have been verified by the study sponsor.