Evaluation of the genital mucosa of a topical product under normal conditions

Phase 1

• Conditions: Female urogenital diseases

• Registration Number: RBR-437fmbz
• Lead Sponsor: Allergisa Pesquisa dermato-cosmética ltda

Brief Summary

During the study, only 01 participant had a feeling of gynecological discomfort probably related to the use of the investigational product, but of mild intensity, representing 2.9% of the population considered for the safety assessment. No participant showed signs of inflammation, edema, abrasions and de-epithelialization of the vaginal mucosa. Therefore, the investigational product can be considered safe under the evaluated conditions.The claims Gynecologically Tested and Clinically Tested can be sustained.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-06-23
• Study Completion: 2022-09-22
• Last Update Posted: 18 September 2023

Recruitment & Eligibility

• Status: Data analysis completed
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Healthy research participants; intact skin in the test region; agreement to adhere to the study procedures and requirements and to attend the institute on the day(s) and time(s) determined for the assessments; ability to consent to their participation in the study; age from 18 to 70 years; female survey participants

Exclusion Criteria

Pregnancy or breastfeeding, having a menstrual period at the time of the study visits, skin pathology in the area of ??application of the product, type 1 diabetes Mellitus, insulin-dependent diabetes, presence of complications due to diabetes (retinopathies, nephropathy, neuropathy); presence of diabetes-related dermatoses (plantar ulcer, necrobiosis lipoidica, granuloma annulare, opportunistic infections);
history of episodes of hypoglycemia, diabetic ketoacidosis and/or hyperosmolar coma, immune failure, Current use of the following topical or systemic medications: corticosteroids, immunosuppressants and antihistamines, skin diseases: vitiligo, psoriasis, atopic dermatitis, history of reaction to the category of product tested, other diseases or medications that may directly interfere with the study or put the health of the research participant at risk

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Expected outcome 1: It is expected that after 21 ± 2 days of use, the product will be considered safe due to the absence or low rate of adverse events and feelings of discomfort in the genital mucosa.;Outcome found 1: During the study, only 01 participant had a feeling of gynecological discomfort probably related to the use of the investigational product, but of mild intensity, representing 2.9% of the population considered for the safety assessment;Expected outcome 2: It is expected to prove the effectiveness of the product through compliance of use by the participants, evaluated through the descriptions in the participant's diary, and medical evaluation.;Outcome found 2: No participant showed signs of inflammation, edema, abrasions and de-epithelialization of the vaginal mucosa. Therefore, the investigational product can be considered safe under the evaluated conditions.

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes were not expected.