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NCT Number: NCT07049068

Comparison of Nicotinamide Treatments for Actinic Keratosis

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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Key information

Conditions

Actinic Keratoses Keratosis Keratosis, Actinic Neoplasms Precancerous Conditions Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Programa de Pós Graduação Ciencias Médicas UFRGS

Porto Alegre, Rio Grande do Sul, 90035003, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral Nicotinamide

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

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.

Primary outcomes

  1. facial actinic keratosis in 6 months

    Time frame: 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 outcomes

  1. facial actinic keratosis in 2 months

    Time frame: From enrollment to the 2 months treatment

    number of actinic keratosis on the face after 2 months of treatment (compared with baseline)

  2. facial actinic keratosis in 4 months

    Time frame: From enrollment to 4 months treatment

    number of actinic keratosis on the face after 4 months of treatment (compared with baseline)

  3. number of squamous cell carcinomas and basal cell carcinomas after 2 months

    Time frame: 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).

  4. number of squamous cell carcinomas and basal cell carcinomas after 4 months

    Time frame: 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

  5. number of squamous cell carcinomas and basal cell carcinomas after 6 months

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Federal University of Rio Grande do Sul

Other

Collaborators

  • Univates

Registry information

Official study title

Double-bllind, Double-dummy, Randomized Clinical Trial Comparative Between Oral Nicotinamide Versus Topical Nicotinamide in the Management of Facial Actinic Keratosis .

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 3, 2025
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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