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

Love Wellness40 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Vaginal Health Vaginal pH

Interventions

pH Balanced CleanserDIETARY_SUPPLEMENT

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.

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Citruslabs

Santa Monica, California, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Baseline and Week 8

Secondary Outcomes

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.

Time frame: Baseline, first use, Week 2, Week 4, Week 6, Week 8

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.