Double-bllind, Double-dummy, Randomized Clinical Trial Comparative Between Oral Nicotinamide Versus Topical Nicotinamide in the Management of Facial Actinic Keratosis .
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- facial actinic keratosis in 6 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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
研究组 & 干预措施
oral nicotinamide (group 1)
Received 120 capsules of 500 mg nicotinamide and a tube of placebo cream at each visit.
干预措施: Oral Nicotinamide (Drug)
topical nicotinamide (group 2)
Participants from group 2 received a tube of 5% nicotinamide cream and 120 placebo capsules.
干预措施: topical nicotinamide (Drug)
结局指标
主要结局
facial actinic keratosis in 6 months
时间窗: 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).
次要结局
- 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)
研究者
Thais Cachafeiro
Principal investigator
Federal University of Rio Grande do Sul