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OpenTrials
Completed

NCT Number: NCT06516731

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.

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Key information

Conditions

Vaginal Health Vaginal pH

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Citruslabs

Santa Monica, California, 90404, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pH Balanced Cleanser

Dietary 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.

Other names: Love Wellness pH Balanced Cleanser

Primary outcomes

  1. Effect of pH Balanced Cleanser on Vulvar and Vaginal Health

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

    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.

  2. Effect of pH Balanced Cleanser on Vulvar and Vaginal Health

    Time frame: Baseline and Week 8

    Vaginal pH testing will be conducted weekly from Baseline to Week 8.

Secondary outcomes

  1. Tolerability of pH Balanced Cleanser

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Love Wellness

Industry

Collaborators

  • Citruslabs

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 24, 2024
Registry last updated
Jul 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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