Comparison of Nicotinamide Treatments for Actinic Keratosis

Federal University of Rio Grande do Sul

Status and phase: Completed; Phase 1

Conditions: Actinic Keratoses

Treatments: Drug: Oral Nicotinamide; Drug: topical nicotinamide

Study type: Interventional

Funder types: Other

Identifiers

NCT07049068

52100621.0.0000.5347

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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74 participants in 2 patient groups

oral nicotinamide (group 1)

Active Comparator group

Description:

Received 120 capsules of 500 mg nicotinamide and a tube of placebo cream at each visit.

Treatment:

Drug: Oral Nicotinamide

topical nicotinamide (group 2)

Active Comparator group

Description:

Participants from group 2 received a tube of 5% nicotinamide cream and 120 placebo capsules.

Treatment:

Drug: topical nicotinamide