A Randomized, Double-blind Crossover Pilot Trial to Compare the Olfactory Perception of a Fragrance-Loaded SpECs Over Time
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 主要终点
- Sustained olfactory perception over time.
研究概览
简要总结
The human olfactory system plays a crucial role in sensory perception, influencing emotional states, memory, and interpersonal interactions(1). Fragrance durability and intensity are critical factors in the evaluation of perfumes and other scented products. The ability of fragrance formulations to maintain consistent scent intensity over time is a major contributor to a product's overall efficacy and consumer satisfaction,
Primary Aim To compare the perceived strength of a topical fragrance delivered via SpECs across a period of 8 hours using subjective ratings by participants and an independent examiner.
Objectives
- To investigate whether the encapsulated fragrance intensity, as perceived by participants, decreases less over time compared with fragrance alone, after application to the skin.
- To investigate whether the encapsulated fragrance intensity, as perceived by an independent examiner, decreases less over time compared with fragrance alone, after application to the skin.
详细描述
The human olfactory system plays a crucial role in sensory perception, influencing emotional states, memory, and interpersonal interactions(1). Fragrance durability and intensity are critical factors in the evaluation of perfumes and other scented products. The ability of fragrance formulations to maintain consistent scent intensity over time is a major contributor to a product's overall efficacy and consumer satisfaction.
SporoSpECsin exine capsules (SpECs), are extracted from either pollen or plant spores in the form of empty porous microcapsules penetrated by nano-diameter sized channels. These channels enable a variety of active ingredients to be loaded into the SpECs chambers; hence, giving universality to the system to encapsulate such as a variety of antibody fragments, oils and proteins and peptides. The preparation that is to be used in this study has been provided to us as a gift by Sporomex Ltd, UK that is presently being used as a cosmetic preparation commercially, and has been investigated as a taste masking agent(2) and for oral pharmaceutical delivery(3).
It is unknown if fragrance loading of these SpECs will enhance the longevity of the fragrance on the skin. This study aims to evaluate the olfactory perception of a SpECs-based fragrance delivery system over an 8-hour period. The study will compare subjective ratings of the fragrance's intensity by participants and an independent examiner. This randomized, double-blind crossover trial will provide insights into the effectiveness of SpECs as a fragrance delivery medium, while also considering the influence of skin chemistry and time on olfactory perception. By eliminating patient variability, crossover studies can be more efficient than equivalently sized parallel group trials, where each participant receives only one treatment. Hence, treatment effects can be measured with greater accuracy using the same number of participants.
Type of Study Pilot randomized, double-blind crossover trial Participants
- Sample size: 10 female participants.
- Inclusion criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Care Provider)
盲法说明
Pilot randomized, double-blind crossover trial
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Females aged between 18 and 45 years.
- •No history of olfactory impairment, allergies to pollen or fragrances, or skin conditions.
排除标准
- •Current use of medications that affect olfactory function (e.g., antihistamines).
- •Pregnancy or breastfeeding.
- •Any active upper respiratory tract infection within 2 weeks of the clinical trial
- •Any known skin allergy.
研究组 & 干预措施
Group A: Fragrance loaded with a concentration of SpECs grains.
Fragrance delivery system: SpECs loaded with fragrance (50mg/ml perfume)
干预措施: Fragrance (Other)
Group B: Fragrance loaded without SpECs grains
fragrance without SpECs
干预措施: Fragrance (Other)
结局指标
主要结局
Sustained olfactory perception over time.
时间窗: 6 hour period- 4 timepoints
The study will determine whether fragrance-loaded SpECs provides a sustained olfactory perception over time.
次要结局
- Impact of SpECs concentration on fragrance(6 hour period- 4 timepoints)
- alignment between participant's and independent examiner's ratings(6 hour period- 4 timepoints)