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Набор скоро начнётся NCT07383337

Comparing the Olfactory Perception of a Fragrance-Loaded SpECs Over Time

Без фазы С лечением Perception, Self

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Fragrance.
Кому может быть актуально
Состояния в реестре: Perception, Self. Базовые параметры: 18 лет — 45 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
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Официальное название

A Randomized, Double-blind Crossover Pilot Trial to Compare the Olfactory Perception of a Fragrance-Loaded SpECs Over Time

Обзор

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 1. To investigate whether the encapsulated fragrance intensity, as perceived by participants, decreases less over time compared with fragrance alone, after application to the skin. 2. 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.

Подробное описание

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:

* Females aged between 18 and 45 years. * No history of olfactory impairment, allergies to pollen or fragrances, or skin conditions. * Exclusion criteria:

* 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. Intervention * Fragrance delivery system: SpECs loaded with fragrance (50mg/ml perfume) versus fragrance without SpECs * Application: A smear layer of the fragrance-loaded SpECs will be applied to the wrist of each participant.

Randomization and Blinding

* Participants will be randomized into two groups:

1. Group A: Fragrance loaded with a concentration of SpECs grains. 2. Group B: Fragrance loaded without SpECs grains. * Double-blinding: Neither the participants nor the independent examiner will know which preparation of the fragrance will be applied to the skin.

Вмешательства

  • Другое Fragrance
    this intervention involves the controlled use of specific fragrance with and withouth SpECs grains

Первичные конечные точки

  • Sustained olfactory perception over time. [Срок оценки: 6 hour period- 4 timepoints]
Вторичные конечные точки (2)
  • Impact of SpECs concentration on fragrance [Срок оценки: 6 hour period- 4 timepoints]
  • alignment between participant's and independent examiner's ratings [Срок оценки: 6 hour period- 4 timepoints]

Критерии участия

Критерии включения

  • Females aged between 18 and 45 years.
  • No history of olfactory impairment, allergies to pollen or fragrances, or skin conditions.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Двойное слепое
Основная цель
Фундаментальное исследование

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

  • Herz RS. The Role of Odor-Evoked Memory in Psychological and Physiological Health. Brain Sci. 2016 Jul 19;6(3):22. doi: 10.3390/brainsci6030022. PMID 27447673
  • Diego-Taboada A , Maillet L , Banoub JH , Lorch M , Rigby AS , Boa AN , Atkin SL , Mackenzie G . Protein free microcapsules obtained from plant spores as a model for drug delivery: ibuprofen encapsulation, release and taste masking. J Mater Chem B. 2013 Feb 7;1(5):707-713. doi: 10.1039/c2tb00228k. Epub 2012 Nov 27. PMID 32260776
  • Wakil A, Mackenzie G, Diego-Taboada A, Bell JG, Atkin SL. Enhanced bioavailability of eicosapentaenoic acid from fish oil after encapsulation within plant spore exines as microcapsules. Lipids. 2010 Jul;45(7):645-9. doi: 10.1007/s11745-010-3427-y. Epub 2010 May 22. PMID 20495964

Идентификаторы

NCT: NCT07383337 · 271/20-May-2025

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗