Comparison of Nicotinamide Treatments for Actinic Keratosis

NCT07049068 | Completed Phase 1

• 1 other identifier: 52100621.0.0000.5347
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Actinic Keratoses

Keywords

actinic keratosis; nicotinamide; topical nicotinamide; oral nicotinamide

Outcome Measures

Primary Outcomes (1)

• facial actinic keratosis in 6 months

  The primary outcome is the number of facial actinic keratosis after 6 months of treatment (compared with baseline).

  From enrollment to the end of treatment at 6 months

Secondary Outcomes (5)

• facial actinic keratosis in 2 months

  From enrollment to the 2 months treatment

• facial actinic keratosis in 4 months

  From enrollment to 4 months treatment

• 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 after 4 months

  from enrollment to 4 months treatment

• number of squamous cell carcinomas and basal cell carcinomas after 6 months

  from enrollment to 6 months treatment

Study Arms (2)

oral nicotinamide (group 1)

ACTIVE COMPARATOR

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

Drug: Oral Nicotinamide

topical nicotinamide (group 2)

ACTIVE COMPARATOR

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

Drug: topical nicotinamide

Interventions

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.

oral nicotinamide (group 1)

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.

topical nicotinamide (group 2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of Rio Grande do Sul: lead
• Univates: collaborator

Study Sites (1)

Programa de Pós Graduação Ciencias Médicas UFRGS

Porto Alegre, Rio Grande do Sul, 90035003, Brazil

Location

Related Publications (4)

• Surjana D, Halliday GM, Martin AJ, Moloney FJ, Damian DL. Oral nicotinamide reduces actinic keratoses in phase II double-blinded randomized controlled trials. J Invest Dermatol. 2012 May;132(5):1497-500. doi: 10.1038/jid.2011.459. Epub 2012 Feb 2. No abstract available.

  PMID: 22297641 BACKGROUND

• Moloney F, Vestergaard M, Radojkovic B, Damian D. Randomized, double-blinded, placebo controlled study to assess the effect of topical 1% nicotinamide on actinic keratoses. Br J Dermatol. 2010 May;162(5):1138-9. doi: 10.1111/j.1365-2133.2010.09659.x. Epub 2010 Mar 1. No abstract available.

  PMID: 20199551 BACKGROUND

• Sivapirabu G, Yiasemides E, Halliday GM, Park J, Damian DL. Topical nicotinamide modulates cellular energy metabolism and provides broad-spectrum protection against ultraviolet radiation-induced immunosuppression in humans. Br J Dermatol. 2009 Dec;161(6):1357-64. doi: 10.1111/j.1365-2133.2009.09244.x. Epub 2009 Apr 20.

  PMID: 19804594 BACKGROUND

• Chen AC, Martin AJ, Choy B, Fernandez-Penas P, Dalziell RA, McKenzie CA, Scolyer RA, Dhillon HM, Vardy JL, Kricker A, St George G, Chinniah N, Halliday GM, Damian DL. A Phase 3 Randomized Trial of Nicotinamide for Skin-Cancer Chemoprevention. N Engl J Med. 2015 Oct 22;373(17):1618-26. doi: 10.1056/NEJMoa1506197.

  PMID: 26488693 BACKGROUND

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

Niacinamide

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: randomized, double-blind, double-dummy clinical trial

Study Record Dates

• First Submitted: June 7, 2025
• First Posted: July 3, 2025
• Study Start: February 1, 2022
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: from now for 3 years

Locations

BR (1)