Clinical trial · Interventional
Comparison of Nicotinamide Treatments for Actinic Keratosis
Double-bllind, Double-dummy, Randomized Clinical Trial Comparative Between Oral Nicotinamide Versus Topical Nicotinamide in the Management of Facial Actinic Keratosis .
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Actinic Keratoses | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oral Nicotinamide | Drug | Niacinamide | ALIAS |
| topical nicotinamide | Drug | Niacinamide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- oral nicotinamide (group 1)
- description
- Received 120 capsules of 500 mg nicotinamide and a tube of placebo cream at each visit.
- interventionNames
- Drug: Oral Nicotinamide
- type
- ACTIVE_COMPARATOR
- label
- topical nicotinamide (group 2)
- description
- Participants from group 2 received a tube of 5% nicotinamide cream and 120 placebo capsules.
- interventionNames
- Drug: topical nicotinamide
Primary outcomes (1)
- measure
- facial actinic keratosis in 6 months
- timeFrame
- From enrollment to the end of treatment at 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (4)
- BACKGROUNDSurjana 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
- BACKGROUNDMoloney 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
- BACKGROUNDSivapirabu 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
- BACKGROUNDChen 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