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

NCT06516731 | Completed

• 1 other identifier: 20401
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaginal Health; Vaginal pH

Keywords

pH Balanced Cleanser; Vaginal Health; Women's Health; Intimate Hygiene; Intimate Skin Care

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Tolerability of pH Balanced Cleanser

  Baseline, first use, Week 2, Week 4, Week 6, Week 8

Study Arms (1)

pH Balanced Cleanser

EXPERIMENTAL

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

Interventions

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.

Also known as: Love Wellness pH Balanced Cleanser

pH Balanced Cleanser

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Love Wellness: lead
• Citruslabs: collaborator

Study Sites (1)

Citruslabs

Santa Monica, California, 90404, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 24, 2024
• Study Start: February 9, 2024
• Primary Completion: June 3, 2024
• Study Completion: June 3, 2024
• Last Updated: July 24, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)