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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A: Fragrance loaded with a concentration of SpECs grains.
Fragrance delivery system: SpECs loaded with fragrance (50mg/ml perfume)
this intervention involves the controlled use of specific fragrance with and withouth SpECs grains
Active Comparator: Group B: Fragrance loaded without SpECs grains
fragrance without SpECs
this intervention involves the controlled use of specific fragrance with and withouth SpECs grains

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sustained olfactory perception over time.
Time Frame: 6 hour period- 4 timepoints
The study will determine whether fragrance-loaded SpECs provides a sustained olfactory perception over time.
6 hour period- 4 timepoints

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of SpECs concentration on fragrance
Time Frame: 6 hour period- 4 timepoints
Insights into the impact of SpECs concentration on fragrance strength and duration will be obtained.
6 hour period- 4 timepoints
alignment between participant's and independent examiner's ratings
Time Frame: 6 hour period- 4 timepoints
The alignment between participant's subjective ratings and the independent examiner's ratings will help validate the reliability of self-assessments in olfactory studies.
6 hour period- 4 timepoints

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Mariam Murad, Royal College of Surgeons, Ireland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 15, 2026

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

January 26, 2026

First Submitted That Met QC Criteria

January 26, 2026

First Posted (Actual)

February 3, 2026

Study Record Updates

Last Update Posted (Actual)

February 5, 2026

Last Update Submitted That Met QC Criteria

February 3, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Perception, Self

Clinical Trials on Fragrance

Subscribe