Comparison of Nicotinamide Treatments for Actinic Keratosis (NCT07049068) | Clinical Trial Compass
CompletedPhase 1
Comparison of Nicotinamide Treatments for Actinic Keratosis
Brazil74 participantsStarted 2022-02-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
facial actinic keratosis in 6 months
Timeframe: From enrollment to the end of treatment at 6 months