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

NCT05738733 | Completed

• 1 other identifier: NB230002-TT
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

A Proof of Science, Open-Label, Single Centre, Four-Arm, In-Use Tolerance, Safety, and Efficacy Clinical Study of MsChief Personal Lubricant in Healthy Female Subjects. 30 subjects/product (33 subjects' enrolment/treatment) healthy non-pregnant/non-lactating females with an age of 18 - 65 years old. A total of up to 132 subjects (33 subjects/product) will be enrolled to get 120 completed subjects (30 subjects/product) in the study.

Conditions

Healthy Females

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.

Device: MsChief Ylang Ylang Natural Lubricant

MsChief Vanilla & Citrus Natural Lubricant

EXPERIMENTAL

MsChief vanilla and citrus natural lubricant contain 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 vanilla and citrus 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.

Device: MsChief Vanilla & Citrus Natural Lubricant

MsChief Tea & Peach Natural Lubricant

EXPERIMENTAL

MsChief tea \& peach 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 tea \& peach 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 contains natural flavour and 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 Tea & Peach Natural Lubricant

Interventions

MsChief Classic Natural Lubricant DEVICE

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

MsChief Classic Natural Lubricant

MsChief Ylang Ylang Natural Lubricant DEVICE

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

MsChief Ylang Ylang Natural Lubricant

MsChief Vanilla & Citrus Natural Lubricant DEVICE

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

MsChief Vanilla & Citrus Natural Lubricant

MsChief Tea & Peach Natural Lubricant DEVICE

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

MsChief Tea & Peach Natural Lubricant

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18 to 65 years (both inclusive) at the time of consent.
• Sex: Healthy non-pregnant/non-lactating females
• Females of fertile reproductive age with a propensity to vulvo-vaginal infection (18 years to 40 years)
• Females in the pre-menopausal age group (41 years to 48 years)
• Females in the post-menopausal age group (49 years to 65 years)
• The subject is with Nugent score ≤3.
• The subject with an active sex life of at least 01 sexual intercourse in a week
• The subject of childbearing potential must have a reported negative pregnancy during screening and the end of the study.
• The subject without a history of sensitivity to similar products/formulations
• The subject is willing to give written informed consent and is willing to follow the study procedures.
• The subject is willing to abide by the study protocol and study restrictions including abstinence from the use of any other product besides the test product for intimate wash, lubricant or any other products during the study.
• The subject is a personal lubricant user and agrees to replace her usual personal lubricant with the test product.
• The subject of childbearing potential who is willing to use a highly effective method of contraception throughout the clinical investigation.
• The subject is of childbearing potential, is practising and agrees to maintain an established method of birth control (IUD, hormonal implant device/injection, regular use of birth control pills or patch, diaphragm, condoms, partner vasectomy or abstinence). Females will be considered as non-childbearing potential if they are surgically sterile, have been post-menopausal for at least 1 year or have had a tubal ligation.
• If currently using hormonal contraception, has been using this form of contraception for at least 6 months and agrees to continue using the same contraception for the duration of the study.

You may not qualify if:

• The subject used other intra-vaginal gel moisturizers during the study.
• The subject with Nugent score \>3.
• The subject who is diagnosed with cancer
• The subject using hormone replacement therapy for the last 3 months
• The subject has a history or visible evidence of chronic skin disease or regional infections, genital herpes, vaginal infections or urinary tract infections.
• Pregnant or lactating, women who are likely to become pregnant.
• The subject exhibits or reports gynecologic abnormalities or has had vaginitis within 60 days prior to study initiation.
• Personal history of allergy and hypersensitivity to any product of feminine hygiene, severe systemic complications of viral infections, severe systemic illness like cardiovascular disorders, neurological disorders, renal disorders, and autoimmune disorders.
• The subject with any form of chronic infection/ allergy/ disease which may influence the study result
• The subject with bacterial vaginosis/candidiasis/mycotic infections
• The subject participated in clinical studies or had received any investigational agent in the previous 30 days.
• The subject is not willing to sign an informed consent form.
• The subject is an employee at the site or a partner or first-degree relative of the Investigator.
• The subject fails to satisfy the Investigator of fitness to participate for any other reason.
• The subject has had previous episodes of vaginal bleeding of unknown origin within the last 6 months of the screening visit.

Sponsors & Collaborators

• NovoBliss Research Pvt Ltd: lead
• TTK Healthcare Ltd - Protective Devices Division: collaborator

Study Sites (1)

Krisha Hospital

Gandhinagar, Gujarat, 382421, India

Location

Study Officials

• Dr Nayan K Patel, MBBS

  Medical Director

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The study is open-label.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator - Medical Director

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

Study Record Dates

• First Submitted: January 31, 2023
• First Posted: February 22, 2023
• Study Start: March 2, 2023
• Primary Completion: April 22, 2023
• Study Completion: May 30, 2023
• Last Updated: July 10, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)