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Perceived Effectiveness of the Vaginal Moisturizer Investigational Product Under Normal Conditions of Use. | Clinical Trials | Clareo Health

COMPLETEDNA

Perceived Effectiveness of the Vaginal Moisturizer Investigational Product Under Normal Conditions of Use.

NCT06353945•Herbarium Laboratorio Botanico Ltda

View on ClinicalTrials.gov

Summary

The present research project aims to evaluate the perceived effectiveness of the product under investigation under normal conditions of use for 28 days, to defend the claims "High hydration power, relief of discomfort and improvement of vaginal tone."

Detailed Description

This research project aims to evaluate the perceived efficacy of the product under investigation under normal conditions of use for 28 days, to defend the attributes expected for this product category. The study will be carried out through the application of questionnaires, which will be answered by the participants. The study will be conducted with a Brazilian sample in which 45 research participants will be included.

Eligibility

Age

25 - 70 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. Age range between 25 and 70 years old.
•2. Phototypes: I to IV, according to Fitzpatrick classification;
•3. Sex: female
•4. Intact skin in the evaluation region.
•5. Participants complaining of vaginal dryness;
•6. Agree to adhere to the study procedures and requirements: study time, return(s) to the laboratory to perform study procedures, home use of the investigational product, filling out the usage diary, not changing cosmetic habits during the study period .
•7. Agree not to carry out dermatological or aesthetic treatments until the end of the study and agree not to use any products from the same category as the investigational product.
•8. Signing of the Free and Informed Consent Form (TCLE).

Exclusion Criteria

•1. Pregnant or breastfeeding women.
•2. Skin marks in the experimental area that interfere with the assessment of possible skin reactions.
•3. Active dermatoses (local or disseminated) that could interfere with the study results.
•4. History of ineffectiveness, allergic reactions, irritation or intense sensation of discomfort to topical products: health products or medications.
•5. Expected vaccination during the study or up to 3 weeks before the study;
•6. Not taking vitamin A (acid and/or its derivatives orally or topically up to 1 month before the start of the study.)
•7. Patients with immunodeficiencies.
•8. History of atopy (atopic dermatitis, allergic rhinitis, allergic bronchitis, allergic conjunctivitis, etc.).
•9. Use of non-steroidal anti-inflammatory drugs, corticosteroids, antihistamines, photosensitizers or immunosuppressants up to 2 weeks before the study (or considering depot corticosteroids, the interval should be 1 month before the selection).
•10. Aesthetic or dermatological treatment up to 4 weeks before the study.
+7 more criteria

Locations (1)

Kosmoscience Ciência e Tecnologia Cosmética Ltda

Campinas, São Paulo, Brazil

Key Dates

Start Date

June 10, 2024

Primary Completion Date

July 10, 2024

Completion Date

July 18, 2024

Last Updated

November 18, 2024

Enrollment

ACTUAL participants

Conditions

Vaginal Atrophy

Interventions

vaginal moisturizer

DEVICE

Efficacy and Safety of Vaginal Radiofrequency for Vulvovaginal Atrophy in Breast Cancer Patients

NCT06900374

Vaginal DrynessBreast Cancer+1 more

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RECRUITINGNA

Clinical and Molecular Study to Evaluate the Effect of the Pixel CO2 Laser (FemiLiftTM) for the Treatment of Vulvo-Vaginal Atrophy

NCT07024667

Vulvar AtrophyVaginal Atrophy

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 18, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Perceived Effectiveness of the Vaginal Moisturizer Investigational Product Under Normal Conditions of Use.

Inclusion Criteria

Exclusion Criteria

Efficacy and Safety of Vaginal Radiofrequency for Vulvovaginal Atrophy in Breast Cancer Patients

Clinical and Molecular Study to Evaluate the Effect of the Pixel CO2 Laser (FemiLiftTM) for the Treatment of Vulvo-Vaginal Atrophy

Clinical Investigation to Assess Safety and Efficacy of INNEA AQUA in Adult Women With Vulvo-Vaginal Atrophy (VVA)

LASER and Radiofrequency for Treatment of Vaginal Vulvar Atrophy (VVA) in Women Treated for Breast Cancer (EPMLARF-arm2)

Regenerative Treatment of Female Genital Atrophy

Local DHEA and Estradiol on Dyspareunia in Postmenopausal Women