A Clinical Efficacy Study of MsChief Personal Lubricant in Healthy Female Subjects
Condition: Healthy Females
Study type: Interventional

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.
    

Detailed description: 
      A sufficient number of healthy female subjects with an age group of 18 - 65 years old with a
      Nugent score ≤3 will be recruited/enrolled.

      The potential subjects will be screened as per the inclusion & exclusion criteria only after
      obtaining written informed consent from the subjects. The subjects will be instructed to
      visit the facility as per the below visits

        -  Visit 01 (Within 07 Days): Screening, Baseline evaluations

        -  Visit 02 (Day 01): Enrolment & Test Products usage phase start

        -  Visit 03 (Day 16): Test Products usage ends, End of the study Subjects will be
           pre-screened by the screening department of NovoBliss Research. Subjects will be
           telephonically contacted by recruiting department prior to the enrolment visit. Subjects
           will be instructed during screening (prior to enrolment) not to use any other product
           for intimate washes, lubricant, or any other product during the study.

      Assessment of efficacy parameters will be done before test products usage on Day 1 and will
      be compared with after test products usage during Day 16 as listed below.

        1. Gynaecological Assessments

             -  Local irritation, pruritus, erythema, edema

             -  Moisturizing effect - moisture, dryness, flaking, epithelial mucosa

             -  Quality and odour of vaginal discharge

             -  Vaginal pH measure using pH paper

             -  Clinical symptoms associated with infections

             -  Verbal rating scale (0-4 score)- Vaginal itching

        2. Subjective Self-assessments

             -  Perceived irritations - Burning, Itching, Stinging, Discomfort

             -  Sexual activity (where appropriate)

             -  VAS Scoring for Vaginal itchiness

             -  Quality of life assessment

        3. Microbiological Assessments • Nugents scoring
    

Intervention name(s): MsChief Classic Natural Lubricant; MsChief Ylang Ylang Natural Lubricant; MsChief Vanilla & Citrus Natural Lubricant; MsChief Tea & Peach Natural Lubricant
Intervention type(s): Device; Device; Device; Device
Intervention description(s): Apply the desire amount of lubricant on the body to make it more sensitive.; Apply the desire amount of lubricant on the body to make it more sensitive.; Apply the desire amount of lubricant on the body to make it more sensitive.; Apply the desire amount of lubricant on the body to make it more sensitive.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A proof-of-science, open-label, single-centre, four-arm, In-Use tolerance, safety, efficacy clinical study
Masking: None (Open Label)
Primary purpose: Prevention