Perception & Acceptability of a Cervical Cancer Prevention Prebiotic Device
Perception & Acceptability of a Cervical Cancer Prevention Prebiotic Device
PreBioGyn will be compared to market leading vaginal pH buffering gels using established
 forearm test methods associated with vaginal lubricity sensation in 42 women. Women will also
 rate each gel for smell and appearance using established methods. The PreBioGyn gel enclosure
 and intravaginal applicator design will be evaluated for: look and feel, ability to prepare
 for dosing, ability to expulse dose, and likelihood of future use by subjects. Open-ended
 feedback on the gel and applicator will occur to gather contributions for each product.
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:

 1. 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.

 2. 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.

 1. 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.

 2. 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.

 3. 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.
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