Comparison of Nicotinamide Treatments for Actinic Keratosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2024-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Actinic Keratoses

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized, double-blind, double-dummy clinical trial

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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oral nicotinamide (group 1)

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

Group Type ACTIVE_COMPARATOR

Oral Nicotinamide

Intervention Type DRUG

Participants from group 1 received 120 capsules of 500 mg nicotinamide and a tube of placebo cream at each visit. . All participants were instructed to take 1 capsule every 12 hours and to apply the cream to their entire face twice a day.

Participants were unaware of which group they were allocated to and participants in both groups received either capsules (active or placebo, which looked identical) or a tube of cream (active or placebo, which looked identical). In follow-up visits participants returned empty tubes to the responsible pharmacist.

At the initial assessment and at 6 months photographs of the participants' faces were taken.

topical nicotinamide (group 2)

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

Group Type ACTIVE_COMPARATOR

topical nicotinamide

Intervention Type DRUG

Participants from group 2 received a tube of 5% nicotinamide cream and 120 placebo capsules. All participants were instructed to take 1 capsule every 12 hours and to apply the cream to their entire face twice a day.

Participants were unaware of which group they were allocated to and participants in both groups received either capsules (active or placebo, which looked identical) or a tube of cream (active or placebo, which looked identical). In follow-up visits participants returned empty tubes to the responsible pharmacist.

At the initial assessment and at 6 months photographs of the participants' faces were taken.

Interventions

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Oral Nicotinamide

Participants from group 1 received 120 capsules of 500 mg nicotinamide and a tube of placebo cream at each visit. . All participants were instructed to take 1 capsule every 12 hours and to apply the cream to their entire face twice a day.

Participants were unaware of which group they were allocated to and participants in both groups received either capsules (active or placebo, which looked identical) or a tube of cream (active or placebo, which looked identical). In follow-up visits participants returned empty tubes to the responsible pharmacist.

At the initial assessment and at 6 months photographs of the participants' faces were taken.

Intervention Type DRUG

topical nicotinamide

Participants from group 2 received a tube of 5% nicotinamide cream and 120 placebo capsules. All participants were instructed to take 1 capsule every 12 hours and to apply the cream to their entire face twice a day.

Participants were unaware of which group they were allocated to and participants in both groups received either capsules (active or placebo, which looked identical) or a tube of cream (active or placebo, which looked identical). In follow-up visits participants returned empty tubes to the responsible pharmacist.

At the initial assessment and at 6 months photographs of the participants' faces were taken.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No