Comparison of Nicotinamide Treatments for Actinic Keratosis

Not Applicable

Completed

• Conditions: Actinic Keratoses
• Interventions: Drug: Oral Nicotinamide; Drug: topical nicotinamide

• Registration Number: NCT07049068
• Lead Sponsor: Federal University of Rio Grande do Sul

Brief Summary

In this study, the investigators aimed to evaluate the effect of oral nicotinamide compared to topical nicotinamide in the presence of actinic keratoses on the face. The reason that led the investigators to study this subject is that previous studies have shown possible favorable effects of nicotinamide, both topical and oral, in the prevention of precursor lesions of skin cancer. However, there are no studies to date comparing topical and oral presentations of nicotinamide in the prevention of the appearance of actinic keratoses and in the regression of the number of actinic keratoses.

In this randomized clinical trial, 74 participants with actinic keratoses on the face received either oral nicotinamide and topical placebo or topical nicotinamide and oral placebo for 6 months.

Detailed Description

Background: Nicotinamide has been reported to be effective in reducing rates of actinic keratosis, however, to date, there are no studies comparing their topical and oral presentations Objectives: to compare efficacy of oral and topical nicotinamide in preventing and reducing the number of facial actinic keratosis. Secundary objectives: to evaluate the occurrence of non-melanoma skin cancer (NMSC) and evaluate the safety and adverse effect profile of topical and oral nicotinamide.

Methods: In this randomized, double-blind, double-dummy clinical trial, 74 participants with actinic keratosis on the face received either oral nicotinamide and topical placebo or topical nicotinamide and oral placebo for 6 months.

Study Timeline

• Study Start: 2022-02-01
• Primary Completion: 2024-11-30
• Study Completion: 2024-11-30
• Status Verified: 2025-06
• Study First Submitted: 2025-06-07
• Study First Submitted QC: 2025-06-24
• Last Update Submitted: 2025-06-24
• Study First Posted: 2025-07-03
• Last Update Posted: 2025-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

• male individuals over 18 years of age
• female individuals with tubal ligation, hysterectomy or over 45 years of age in menopause
• presence of at least three palpable actinic keratoses on the face

Exclusion Criteria

• individuals with an incidence of 3 or more squamous cell carcinomas in the last year
• solid organ transplant recipients
• carriers of the human immunodeficiency virus (HIV)
• solid organs cancer
• active gastric ulcer
• recent history of acute myocardial infarction
• hypotension
• pregnancy
• lactation
• chronic liver disease
• liver or kidney failure
• xeroderma pigmentosum
• albinism
• epidermodysplasia verruciformis
• dystrophic epidermolysis bullosa
• nevoid basal cell carcinoma syndrome
• individuals with a large number of confluent actinic keratosis (making it impossible to count individual lesions)
• Individuals using carbamazepine
• Individuals using oral retinoids
• Individuals using oral supplements containing nicotinamide
• Individuals who had undergone field treatments for actinic keratoses such as 5-fluorouracil in the last 4 months
• individuals who were unable to understand the objectives and risks of treatment
• Individuals who refused to participate or sign the consent form

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
oral nicotinamide (group 1)	Oral Nicotinamide	Received 120 capsules of 500 mg nicotinamide and a tube of placebo cream at each visit.
topical nicotinamide (group 2)	topical nicotinamide	Participants from group 2 received a tube of 5% nicotinamide cream and 120 placebo capsules.

Primary Outcome Measures

Name	Time	Method
facial actinic keratosis in 6 months	From enrollment to the end of treatment at 6 months	The primary outcome is the number of facial actinic keratosis after 6 months of treatment (compared with baseline).

Secondary Outcome Measures

Name	Time	Method
facial actinic keratosis in 4 months	From enrollment to 4 months treatment	number of actinic keratosis on the face after 4 months of treatment (compared with baseline)
number of squamous cell carcinomas and basal cell carcinomas after 2 months	from baseline to 2 months treatment	number of squamous cell carcinomas and basal cell carcinomas in the treated area and on the whole body after 2 months of treatment (compared with baseline).
number of squamous cell carcinomas and basal cell carcinomas after 4 months	from enrollment to 4 months treatment	number of squamous cell carcinomas and basal cell carcinomas in the treated area and on the whole body after 4 months
number of squamous cell carcinomas and basal cell carcinomas after 6 months	from enrollment to 6 months treatment	number of squamous cell carcinomas and basal cell carcinomas in the treated area and on the whole body after 6 months
facial actinic keratosis in 2 months	From enrollment to the 2 months treatment	number of actinic keratosis on the face after 2 months of treatment (compared with baseline)

Trial Locations

Locations (1)

Programa de Pós Graduação Ciencias Médicas UFRGS; 🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil