Vaginal Diseases
Conditions
Interventions
This is a single-center, blinded clinical trial to evaluate the safety and efficacy of an intimate lubricant, KY Gel Lubrificante Naturals Bio Jambu. Group: 33 healthy women and 33 healthy men, aged b
Sponsors
Medcin Instituto da Pele LTDA
Medcin Instituto da Pele LTDA
Eligibility
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Female population; female participants aged 18 to 60 years; participants with an active sex life; participants with a pH value between 3.8 and 4.5; heterosexual couples through stable union or civil marriage; intact skin in the area of analysis of the product (vaginal mucosa); must be users of products in the same category; agreement to follow the study procedures and attend the Clinical Research Center on the specified days and times for evaluations; understanding, consent, and signing of the Informed Consent Form (ICF); male population; male participants aged 18 to 60 years; heterosexual couples through stable union or civil marriage; intact skin in the area of analysis of the product (penile region); must be users of products in the same category; agreement to follow the study procedures and attend the Clinical Research Center on the specified days and times for evaluations; understanding, consent, and signing of the Informed Consent Form (ICF)
Exclusion criteria
Exclusion criteria: Pregnancy or risk of pregnancy and/or lactation (for women); sexually transmitted infections, such as candidiasis, trichomoniasis, or conditions that compromise the safety evaluation of the product; use of anti-inflammatory drugs, immunosuppressants, or antihistamines up to 3 weeks before selection; skin markings in the experimental area that interfere with the evaluation of possible skin reactions, such as vascular malformations, scars, increased hair growth, numerous nevi, or sunburns; atopic or allergic history to products in the same category; active skin pathologies or lesions (local or disseminated) in the evaluation area; immunosuppression due to drugs or active diseases; decompensated endocrinopathies; relevant clinical history or current evidence of alcohol or drug abuse; known or suspected intolerance to products in the same category; intense sun exposure up to 15 days before evaluation; aesthetic or dermatological treatment in the evaluation area up to 4 weeks before selection; other conditions deemed reasonable by the investigator for disqualification from participation in the study, which should be described in the clinical record observation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absence of irritation and discomfort after the application of the investigational product, assessed through clinical inspections and subjective questionnaires. Adverse reactions such as erythema, edema, papules, and vesicles will be measured using the scale recommended by the International Contact Dermatitis Research Group (ICDRG). The assessments will take place at the beginning of the study (D0) and after three weeks of continuous use of the product (D21) | — |
Secondary
| Measure | Time frame |
|---|---|
| Maintenance of vaginal pH, assessed through pH strip readings at the beginning of the study (D0) and at the end of the study (D21), and the perceived efficacy of the product, which will be evaluated through a subjective questionnaire administered at the end of the product use period | — |
Countries
Brazil
Contacts
Public ContactFrancisco Viana da Silva
Semina Indústria e Comércio Ltda
Outcome results
None listed