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| Name | Class |
|---|---|
| Citruslabs | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Citruslabs | Santa Monica | California | 90404 | United States |
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