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

Not Applicable

Completed

• Conditions: Vaginal pH; Vaginal Health
• Interventions: Dietary Supplement: pH Balanced Cleanser

• Registration Number: NCT06516731
• Lead Sponsor: Love Wellness

Brief Summary

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.

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 Timeline

• Study Start: 2024-02-09
• Primary Completion: 2024-06-03
• Study Completion: 2024-06-03
• Status Verified: 2024-07
• Study First Submitted: 2024-07-11
• Study First Submitted QC: 2024-07-17
• Last Update Submitted: 2024-07-17
• Study First Posted: 2024-07-24
• Last Update Posted: 2024-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
pH Balanced Cleanser	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.

Primary Outcome Measures

Name	Time	Method
Effect of pH Balanced Cleanser on Vulvar and Vaginal Health	Baseline and Week 8	Vaginal pH testing will be conducted weekly from Baseline to Week 8.

Secondary Outcome Measures

Name	Time	Method
Tolerability of pH Balanced Cleanser	Baseline, first use, Week 2, Week 4, Week 6, Week 8	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.

Trial Locations

Locations (1)

Citruslabs; 🇺🇸 Santa Monica, California, United States