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Comparison of Nicotinamide Treatments for Actinic Keratosis

NCT07049068 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2025-09-15

No results posted yet for this study

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.

Conditions

  • Actinic Keratoses

Interventions

DRUG

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.

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.

Sponsors & Collaborators

  • Univates

    collaborator OTHER

  • Federal University of Rio Grande do Sul

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2024-11-30
Completion
2024-11-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07049068 on ClinicalTrials.gov