Actinic KeratosesPhase 1NCT07049068
Comparison of Nicotinamide Treatments for Actinic Keratosis
A Phase 1 study testing Oral Nicotinamide and topical nicotinamide in people with Actinic Keratoses, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Actinic Keratoses
- What is being tested?
- Oral Nicotinamide and topical nicotinamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Feb 2022to 30 Nov 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 23Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Programa de Pós Graduação Ciencias Médicas UFRGS
Porto Alegre, Rio Grande do Sul, 90035003
About this study
Official title: Double-bllind, Double-dummy, Randomized Clinical Trial Comparative Between Oral Nicotinamide Versus Topical Nicotinamide in the Management of Facial 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.
Read the detailed description
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.
- Conditions
- Actinic Keratoses
- Being tested
- Oral Nicotinamide, topical nicotinamide
- Keywords
- actinic keratosis, nicotinamide, topical nicotinamide, oral nicotinamide
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral NicotinamideDrug
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 nicotinamideDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| oral nicotinamide (group 1) | Active comparator | Received 120 capsules of 500 mg nicotinamide and a tube of placebo cream at each visit. Receives: Drug: Oral Nicotinamide |
| topical nicotinamide (group 2) | Active comparator | Participants from group 2 received a tube of 5% nicotinamide cream and 120 placebo capsules. Receives: Drug: topical nicotinamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
facial actinic keratosis in 6 months
The primary outcome is the number of facial actinic keratosis after 6 months of treatment (compared with baseline).
Measured: From enrollment to the end of treatment at 6 months
Secondary outcomes (5)
facial actinic keratosis in 2 months
number of actinic keratosis on the face after 2 months of treatment (compared with baseline)
Measured: From enrollment to the 2 months treatment
facial actinic keratosis in 4 months
number of actinic keratosis on the face after 4 months of treatment (compared with baseline)
Measured: 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).
Measured: 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
Measured: 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
Measured: from enrollment to 6 months treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start1 Feb 2022
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Actinic KeratosesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, double-blind, double-dummy clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Collaborators
- Univates
- Responsible party
- Principal investigator, Thais Cachafeiro, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07049068
- Sponsor's protocol ID
- 52100621.0.0000.5347
- Status last verified
- Sep 2025
- First submitted
- 7 Jun 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: sex, age, number of actinic keratosis
Publications
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.
PubMed 22297641Moloney 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.
PubMed 20199551Sivapirabu 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.
PubMed 19804594Chen 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.
PubMed 26488693
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-bllind, Double-dummy, Randomized Clinical Trial Comparative Between Oral Nicotinamide Versus Topical Nicotinamide in the Management of Facial Actinic Keratosis .
- ClinicalTrials.gov ID
- NCT07049068
- Acronym / sponsor ID
- 52100621.0.0000.5347
- Conditions
- Actinic Keratoses
- Keywords
- actinic keratosis, nicotinamide, topical nicotinamide, oral nicotinamide
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Collaborators
- Univates
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 3 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- randomized, double-blind, double-dummy clinical trial
| Arm | Type | Receives |
|---|---|---|
| oral nicotinamide (group 1) | Active comparator | Drug: Oral NicotinamideReceived 120 capsules of 500 mg nicotinamide and a tube of placebo cream at each visit. |
| topical nicotinamide (group 2) | Active comparator | Drug: topical nicotinamideParticipants from group 2 received a tube of 5% nicotinamide cream and 120 placebo capsules. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral NicotinamideParticipants 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 | oral nicotinamide (group 1) |
| topical nicotinamideParticipants 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. | Drug | topical nicotinamide (group 2) |
Primary outcome
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).
5 secondary outcomes
facial actinic keratosis in 2 months
Time frame: From enrollment to the 2 months treatment
facial actinic keratosis in 4 months
Time frame: From enrollment to 4 months treatment
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 after 4 months
Time frame: from enrollment to 4 months treatment
number of squamous cell carcinomas and basal cell carcinomas after 6 months
Time frame: from enrollment to 6 months treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Background: PubMed 22297641Surjana 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.
- Background: PubMed 20199551Moloney 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.
- Background: PubMed 19804594Sivapirabu 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.
- Background: PubMed 26488693Chen 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.
- Individual participant dataSharing planned: Yes. sex, age, number of actinic keratosis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oral Nicotinamide and topical nicotinamide in people with Actinic Keratoses, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
facial actinic keratosis in 6 months (time frame: From enrollment to the end of treatment at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07049068, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.