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| Name | Class |
|---|---|
| Univates | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oral nicotinamide (group 1) | Active Comparator | Received 120 capsules of 500 mg nicotinamide and a tube of placebo cream at each visit. |
|
| topical nicotinamide (group 2) | Active Comparator | Participants from group 2 received a tube of 5% nicotinamide cream and 120 placebo capsules. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| facial actinic keratosis in 2 months | number of actinic keratosis on the face after 2 months of treatment (compared with baseline) | From enrollment to the 2 months treatment |
| facial actinic keratosis in 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Programa de Pós Graduação Ciencias Médicas UFRGS | Porto Alegre | Rio Grande do Sul | 90035003 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22297641 | Background | 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. | |
| 20199551 | 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. |
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sex, age, number of actinic keratosis
from now for 3 years
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 16, 2015 | Jul 16, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D009536 | Niacinamide |
| ID | Term |
|---|---|
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
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randomized, double-blind, double-dummy clinical trial
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|
| 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. |
|
number of actinic keratosis on the face after 4 months of treatment (compared with baseline)
| From enrollment to 4 months treatment |
| number of squamous cell carcinomas and basal cell carcinomas after 2 months | 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). | from baseline to 2 months treatment |
| number of squamous cell carcinomas and basal cell carcinomas after 4 months | number of squamous cell carcinomas and basal cell carcinomas in the treated area and on the whole body after 4 months | from enrollment to 4 months treatment |
| number of squamous cell carcinomas and basal cell carcinomas after 6 months | number of squamous cell carcinomas and basal cell carcinomas in the treated area and on the whole body after 6 months | from enrollment to 6 months treatment |
| 19804594 | 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. |
| 26488693 | 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. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |