- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07383337
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
- 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.
Study Overview
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:
- Group A: Fragrance loaded with a concentration of SpECs grains.
- 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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mariam Murad
- Phone Number: 16660087
- Email: mmurad@rcsi.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
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
Investigators
- Principal Investigator: Mariam Murad, Royal College of Surgeons, Ireland
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 271/20-May-2025
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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