A Single Group Study to Evaluate the Effects of a pH Balanced Cleanser on Women's Intimate Health.

This virtual single-group study will last 8 weeks, involving the daily use of a pH Balanced Cleanser by 40 female participants. The study aims to evaluate the effect of the cleanser on signs of vulvar and vaginal health and its tolerability.

Study Overview

• Status: Completed
• Conditions: Vaginal Health; Vaginal pH
• Intervention / Treatment: Dietary supplement: pH Balanced Cleanser

Detailed Description

Participants will use the Love Wellness pH Balanced Cleanser daily during showers. Questionnaires will be completed at Baseline, first use, Week 2, Week 4, Week 6, and Week 8. Vaginal pH testing will be conducted weekly using Vaginox vaginal pH testing strips. The primary objective is to assess parameters of vulvar and vaginal health, while the secondary objective is to evaluate product tolerability.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Monica, California, United States, 90404
      • Citruslabs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Female participants aged 18+
• Self-reported issues with vaginal odor, itching, or intimate skin discomfort
• Previous use of vaginal cleansers without severe adverse reactions
• Generally healthy without uncontrolled chronic diseases
• Willing to avoid intra-vaginal products during the study
• Consistent use of any vaginal health-targeted supplements for at least 3 months prior

Exclusion Criteria:

• Pre-existing chronic conditions preventing protocol adherence
• Planned reproductive health procedures
• Recent changes in medications or supplements targeting vaginal health
• Known severe allergic reactions
• Pregnancy, breastfeeding, or attempting to conceive
• Unwillingness to follow study protocol
• History of vaginal, cervical, vulvar, uterine, or ovarian cancer
• Recent changes or discontinuation of hormonal birth control
• Recent surgeries or invasive treatments

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: pH Balanced Cleanser; Participants will use the pH Balanced Cleanser daily during showers. The study will evaluate the effects on vulvar and vaginal health, including odor and pH levels, and assess the tolerability of the product.

Dietary supplement: pH Balanced Cleanser; Participants will use the pH Balanced Cleanser daily during showers. The cleanser should be applied to the vulva with clean hands, gently worked into a lather, and rinsed clean. Participants will complete baseline and weekly questionnaires and vaginal pH tests over an 8-week period to evaluate the effects on vulvar and vaginal health, including odor and pH levels, and assess the tolerability of the product.; Other Names: Love Wellness pH Balanced Cleanser

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of pH Balanced Cleanser on Vulvar and Vaginal Health	Parameters associated with vulvar and vaginal health, including odor and pH levels, will be evaluated. Participants will complete questionnaires at Baseline, first use, Week 2, Week 4, Week 6, and Week 8.	Baseline, first use, Week 2, Week 4, Week 6, Week 8
Effect of pH Balanced Cleanser on Vulvar and Vaginal Health	Vaginal pH testing will be conducted weekly from Baseline to Week 8.	Baseline and Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tolerability of pH Balanced Cleanser	The tolerability of the product will be evaluated via questionnaires at first use, Week 2, Week 4, Week 6, and Week 8. Parameters of interest include reported irritation or itchiness associated with the product, comfort when using the product, negative changes in vaginal pH associated with product use, and participants' overall perceptions of the product.	Baseline, first use, Week 2, Week 4, Week 6, Week 8

Collaborators and Investigators

• Sponsor: Love Wellness
• Collaborators: Citruslabs

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2024
• Primary Completion (Actual): June 3, 2024
• Study Completion (Actual): June 3, 2024

Study Registration Dates

• First Submitted: July 11, 2024
• First Submitted That Met QC Criteria: July 17, 2024
• First Posted (Actual): July 24, 2024

Study Record Updates

• Last Update Posted (Actual): July 24, 2024
• Last Update Submitted That Met QC Criteria: July 17, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Women's Health; pH Balanced Cleanser; Vaginal Health; Intimate Hygiene; Intimate Skin Care
• Other Study ID Numbers: 20401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No