Randomised, double-blind, placebo controlled study to assess efficacy of oral nicotinamide in the treatment and prevention of actinic keratoses
Recruiting
- Conditions
- Actinic KeratosesSkin - Dermatological conditions
- Registration Number
- ACTRN12609000490279
- Lead Sponsor
- Royal Prince Alfred (provide infrastructural support)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
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.
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
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.[Actinic Keratosis count at baseline and 4 months]
- Secondary Outcome Measures
Name Time Method 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).[Actinic keratosis count at baseline and 2 months]