- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04841629
Perception & Acceptability of a Cervical Cancer Prevention Prebiotic Device
Study Overview
Status
Intervention / Treatment
Detailed Description
This study is being conducted as a component of a NIH/NCI sponsored Small Business Technology Transfer (STTR) project entitled "Cervical Cancer Prevention Prebiotic Device."
The prebiotic vaginal gel, PreBioGyn, has been developed to optimize vaginal health and reduce the risk of cervical cancer in women. Use of the gel targets a combination of biological risk factors for cervical cancer including restoring and maintaining healthy vaginal microbiota, pH, and mucosal function, thereby preventing disturbed immunity and inflammation caused by dysbiosis and mucosal microtrauma. The purpose of this study is to provide a quantitative perception evaluation of the acceptability of PreBioGyn and its applicator system.
The objectives of this study are to:
- Perform a quantitative sensory evaluation to determine the topical acceptability of PreBioGyn, as well as receive qualitative feedback on the gel, as compared to competitive products.
- Obtain quantitative and qualitative feedback regarding acceptability of the PreBioGyn applicator compared to those for existing competitive products.
These Study Objectives do not involve actual intravaginal use of the product. Rather, this activity will involve presentation of the products in a forearm and finger-touch sensory evaluation, and the answering of questions related to this perceptual evaluation.
Study Design:
This is a randomized, single-blind, cross-over study that will include 42 women.
Study Procedures and Methods:
Quantitative sensory evaluation and qualitative feedback to determine the acceptability of the prebiotic vaginal gel (PreBioGyn) as compared to competitive products
Summary:
Quantitative evaluation of PreBioGyn and two competitive vaginal pH buffer-gels will be performed. The four key qualitative parameters to be evaluated are slipperiness, tackiness, appearance, and smell. These parameters are key functional outcomes for the final PreBioGyn formula. Qualitative feedback and likelihood of use for each gel will also be collected and scored.
Quantitative Assessment of Slipperiness and Tackiness ("lubricity").
Quantitative perceptual lubricity (slipperiness and tackiness) will be determined using a standardized methodology wherein participants discriminate differences between the PreBioGyn and two competitive products, versus positive and negative anchor products. Products are evaluated on the skin (forearm area) ex vivo.
Participants will each receive the positive and negative anchors, then the three gel products, on three different 4-cm circular forearm sites. The order of the gels, and the circle to which it was applied, will be determined randomly based on a computer-generated randomization table. Each treatment is replicated twice. Participants will be blinded to the specific products used.
Fingers and circles will be wiped with a low-residue baby-wipe and paper towel. The investigator dispenses 0.2 ml of the sample into the center of the circle previously drawn on the forearm. The sample is rubbed in a circle using the index finger at a rate of 2 revolutions per second for 15 seconds and followed with another 45 seconds (60 second time point). A metronome is set at 120 bpm and played to standardize the manipulation rate.
At time points 15 and 60 seconds, slipperiness is evaluated using a visual analog scale (VAS). The two ends of the visual analog scale are anchored by the phrases "not slippery" and "very slippery." The participant is asked to make a mark on the VAS at the point of their slipperiness assessment between the two anchors. Prior to study gel measurements, participants will perform evaluations on two products representing the negative anchor "not slippery" (lanolin) and positive anchor "very slippery" (Gun Oil™ lubricant).
At the 60-second time point, and after the slipperiness score is recorded, subjects will assess tackiness by tapping their finger up and down for 5 seconds on the skin in the circle just used to assess slipperiness.
Tackiness is evaluated using the visual analog scale. The two ends of the visual analog scale are anchored by the phrases "Not tacky or sticky" and "very tacky or sticky." The focus group participant is asked to make a mark on the VAS at the point of their tackiness assessment between the two anchors. Prior to study gel measurements, participants will perform evaluations on two products representing the anchors of "very tacky" (lanolin) and "not tacky" (Gun Oil® lubricant). The degree of slipperiness and tackiness is determined by measuring the distance of the participants mark on the visual analog scale from the left baseline.
Qualitative Assessment of Appearance and Smell and Overall Perception.
Study participants will be asked to rate the appearance and smell of the PreBioGyn and competitive products following the end of the quantitative assessment period. The traditional nine-point hedonic scale will be used to assess the degree of liking or disliking of each gel's smell and appearance. The reliability, validity and discriminative ability of the scale has been proven in food, cosmetic, and personal care product acceptance tests.
Two milliliters (2 ml) of each lubricant will be dispensed from a prefilled syringe onto a small clear plastic petri dish. The order of the gel will be determined randomly based on a computer-generated randomization table. Each treatment is replicated twice. Participants will be blinded to the product identity. Subjects will be asked to observe the gels under good lighting, smell the gels from a distance of approximately 2-5 cm from the end of their nose, and then rate each gel on the Hedonic scale. Finally, open-ended feedback on the gels, including likelihood of use as a proposed product to decrease cervical cancer risk, will occur using the "I Like, I Wish, What If" method to gather participant contributions.
- Quantitative and Qualitative Feedback Regarding Acceptability of the PreBioGyn Applicator Compared to Competitive Products.
Women will rank the PreBioGyn applicator versus that of competitive products in a 9-point Hedonic scale for acceptability of the applicator look and feel; the usability for preparing the applicator for dosing, and the usability to expel the gel (table-top). Finally, the overall reaction to the concept of inserting each applicator vaginally will be rated, as well as a 5-point Likert-scale rating of likelihood of future use of each product to reduce cervical cancer risk. Finally, open-ended feedback on the applicators will occur using the "I Like, I Wish, What If" method to gather participant contributions.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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San Juan, Puerto Rico, 00936
- University of Puerto Rico Medical Sciences
-
-
-
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Brigham and Women's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Female
- hrHPV positive
- 30 years of age or older
- Have not received the HPV vaccine
- Not pregnant or nursing
- Medicaid eligible
Exclusion Criteria:
- history of skin irritation and/or allergic skin reactions
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PreBioGyn Gel
Topical administration to forearm
|
Cellulose-based prebiotic gel developed to optimize vaginal health and reduce the risk of cervical cancer in women.
|
Active Comparator: Trimosan Gel
Topical administration to forearm
|
Carbomer-based gel
|
Active Comparator: RepHresh Gel
Topical administration to forearm
|
Carbomer-based gel
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Sensory perceptual characteristics of gels based on forearm testing
Time Frame: 1 hour
|
1 hour
|
User acceptability of gel delivery system
Time Frame: 1 hour
|
1 hour
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Joanna Ellington, PhD, Glyciome, LLC
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R41CA254543 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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