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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07383337
Enrollment
10
Registered
2026-02-03
Start date
2026-02-15
Completion date
2026-03-01
Last updated
2026-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perception, Self

Keywords

fragrance, SpECs, Olfactory

Brief summary

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.

Detailed description

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.

Interventions

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

Sponsors

Royal College of Surgeons in Ireland - Medical University of Bahrain
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Caregiver)

Masking description

Pilot randomized, double-blind crossover trial

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Sustained olfactory perception over time.6 hour period- 4 timepointsThe study will determine whether fragrance-loaded SpECs provides a sustained olfactory perception over time.

Secondary

MeasureTime frameDescription
Impact of SpECs concentration on fragrance6 hour period- 4 timepointsInsights into the impact of SpECs concentration on fragrance strength and duration will be obtained.
alignment between participant's and independent examiner's ratings6 hour period- 4 timepointsThe alignment between participant's subjective ratings and the independent examiner's ratings will help validate the reliability of self-assessments in olfactory studies.

Contacts

CONTACTMariam Murad
mmurad@rcsi.com16660087
PRINCIPAL_INVESTIGATORMariam Murad

Royal College of Surgeons, Ireland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026