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Outcome Measures

Primary Outcomes (4)

Change in vaginal local irritation
To assess the test product(s) effectiveness in terms of change in vaginal local irritation by the Gynecologist using 4-point scale\[0=absent, 1=mild, 2=moderate, 3=severe\]..
From baseline i.e. Day 01 (before application) to Day 16 post usage
Change in vaginal moisturizing effects
To assess the test product(s) effectiveness in terms of change in vaginal moisturizing effects as evaluated by the Gynecologist using Modified Schemer Test
From baseline i.e. Day 01 (before application) to Day 16 post usage
Change in sexual intimacy
To assess the test product(s) effectiveness in terms of change in sexual intimacy using female sexual function index self-reported scale score \[score of zero indicates that the subject reported having no sexual activity during the past 15 days\].
From baseline i.e. Day 01 (before application) to Day 16 post usage
Change in VAS score for vaginal itching
To assess the test product(s) effectiveness in terms of change in Visual Analog Score score for vaginal itching as evaluated by the Gynecologist \[ 0 points - No itchiness, greater than or equal to 9 points: Very severe Itchiness
From baseline i.e. Day 01 (before application) to Day 16 post usage

Secondary Outcomes (5)

Change in quality and odor of vaginal discharge
From baseline i.e. Day 01 (before application) to Day 16 post usage
Change in vaginal pH
From baseline i.e. Day 01 (before application) to Day 16 post usage
Change in clinical symptoms associated with infection
From baseline i.e. Day 01 (before application) to Day 16 post usage
Change in Nugents score
From baseline i.e. Day 01 (before application) to Day 16 post usage
Product perception and consumer feedback
From baseline i.e. Day 01 (before application) to Day 16 post usage

Study Arms (4)

MsChief Classic Natural Lubricant

EXPERIMENTAL

MsChief Classic natural lubricant contains aqua, propylene glycol, hydroxyethyl cellulose, ethyl menthane carboxamide and methyl diisopropyl propionamide, aloe barbadensis leaf juice, benzoic acid, hippophae Rhamnoides extract, tocophersolan, sodium hydroxide. MsChief Classic natural lubricant is a special moisturizer with aloe vera, vitamin E and sea buckthorn. It not only conditions but also moisturises the skin. This lubricant is water-based is free of sugar or saccharine. This product does not contain paraben or glycerine. This product has a unique formulation pH ideal for intimate area.

Device: MsChief Classic Natural Lubricant

MsChief Ylang Ylang Natural Lubricant

EXPERIMENTAL

MsChief Ylang Ylang natural lubricant contains aqua, propylene glycol, flavour, hydroxyethyl cellulose, ethyl menthane carboxamide and methyl diisopropyl propionamide, aloe barbadensis leaf juice, benzoic acid, hippophae Rhamnoides extract, tocophersolan, sodium hydroxide. MsChief Ylang Ylang natural lubricant is a special moisturizer with aloe vera, vitamin E and sea buckthorn It not only conditions but also moisturise the skin. This lubricant is water-based contain natural flavour and free of sugar or saccharine. This product does not contain paraben or glycerine. This product has a unique formulation pH ideal for intimate area.

Interventions

MsChief Classic Natural LubricantDevice

Apply the desire amount of lubricant on the body to make it more sensitive.

MsChief Classic Natural Lubricant

MsChief Ylang Ylang Natural LubricantDevice

Apply the desire amount of lubricant on the body to make it more sensitive.

MsChief Ylang Ylang Natural Lubricant

Study Design

Study Type

interventional

Phase

not applicable

Allocation

RANDOMIZED

Masking

NONE

Masking Details

The study is open-label.

Purpose

PREVENTION

Intervention Model

PARALLEL

Model Details: A proof-of-science, open-label, single-centre, four-arm, In-Use tolerance, safety, efficacy clinical study

Sponsor Type

OTHER

Responsible Party

PRINCIPAL INVESTIGATOR

PI Title

Principal Investigator - Medical Director

A Clinical Efficacy Study of MsChief Personal Lubricant in Healthy Female Subjects

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (5)

Study Arms (4)

MsChief Classic Natural Lubricant

MsChief Ylang Ylang Natural Lubricant

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

MsChief Vanilla & Citrus Natural Lubricant

MsChief Tea & Peach Natural Lubricant

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (5)

Study Arms (4)

MsChief Classic Natural Lubricant

MsChief Ylang Ylang Natural Lubricant

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

MsChief Vanilla & Citrus Natural Lubricant

MsChief Tea & Peach Natural Lubricant

You may not qualify if:

Data Sharing

Source record

Locations