Randomised, double-blind, placebo controlled study to assess efficacy of oral nicotinamide (500mg daily) in the treatment and prevention of actinic keratoses.

Phase 2

Completed

• Conditions: Actinic keratoses; Skin - Dermatological conditions

• Registration Number: ACTRN12610000689077
• Lead Sponsor: Royal Prince Alfred Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-08-20
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

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.

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in total actinic keratosis (AK) count at 2 and 4 months from baseline[2 and 4 months]

Secondary Outcome Measures

Name	Time	Method
il[Nil]