Allergisa Pesquisa Dermato-Cosmética Ltda
Campinas, São Paulo, 13084-791, Brazil
NCT Number: NCT04247022
The research will be conducted with a product for use in the intimate region in up to 75 research participants who will use the investigational product for 28 ± 2 days. Will be evaluated and followed up throughout the study by a gynecologist to verify the safety and effectiveness of the product and possible adverse events.
The study will evaluate the non-interference of a topical use product on the intimate area, helping to preserve the natural defenses. In addition, the epithelial hydration and pH of the intimate area will be evaluated.
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Notify Me18 year–59 year
Female
Interventional
Not applicable
Campinas, São Paulo, 13084-791, Brazil
74 female participants, 18 to 59 years of age, healthy with complaints of vaginal dryness. The subjects will be submitted to gynecological evaluation in which pH measurements, hydration measurements and bacterioscopic collection will be performed. Then they will be guided to answer the questionnaires of Perceived Efficacy and Quality of Sexual Life. Next, participants will receive the product for home use, under real conditions of use, for 28 ± 2 days. After 28 ± 2 days of use, subjects will return to the institute, and undergo further evaluations with the gynecologist. New pH measurements, hydration measurements (chronometry), bacterioscopic collection will be performed and the participants will answer the Perceived Efficacy and Quality of Sexual Life questionnaires.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
heath care product (intimate gel) for home use, under real conditions of use, for 28 ± 2 days
Time frame: 28 ± 2 days
Evaluate the perceived hydration through a subjective questionnaire
Time frame: 28 ± 2 days
Evaluate the hydration, through a hydration measurements by chronometry.
Time frame: 28 ± 2 days
pH measurements
Time frame: 28 ± 2 days
bacterioscopic collection
Herbarium Laboratorio Botanico Ltda
Industry
Evaluation of Cutaneous Acceptability and Genital Mucosa Acceptability of a Health Care Product (Intimate Gel), and Interference of Microbiota and pH Around the Vaginal Introit, With Instrumental Evaluation of the Mucosa Hydratation
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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