Evaluation of Gynecological Acceptability of 3 Health Care Products
1 other identifier
interventional
65
1 country
1
Brief Summary
The research was conduct with 3 different products for use in the intimate region in up to 70 research participants, that use the investigational product by 35 ± 2 days. The subjects were follow up throughout the study by a gynecologist for verification of safety, effectiveness and possible adverse events.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 6, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 10, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 21, 2020
CompletedFirst Submitted
Initial submission to the registry
March 26, 2020
CompletedFirst Posted
Study publicly available on registry
March 31, 2020
CompletedApril 3, 2020
April 1, 2020
1 month
March 26, 2020
April 1, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Perceived hydration
Evaluate the perceived hydration, through a subjective questionnaire based on "Standard Guide for Sensory Claim Substantiation"
9 days
Study Arms (3)
women, 18-39 y
EXPERIMENTALHealth volunteers, 18-39 y, with vaginal dryness
premenopause women
EXPERIMENTALHealth volunteers, 40 years to premenopause, with vaginal dryness
climacteric women
ACTIVE COMPARATORHealth volunteers, climacteric, with vaginal dryness
Interventions
Health care product (intimate gel)
Health care product (intimate gel)
Health care product (intimate gel)
Eligibility Criteria
You may qualify if:
- Health volunteers
- Non-injured mucosa in the test region;
- Agreement to adhere to study procedures and requirements and attend the institute on the day(s) and time(s) determined for the evaluations;
- Ability to consent to their participation in the study;
- Age from 18 to 70 years old;
- Female participants;
- Vaginal dryness (slight minimum) - according to questions from the gynecologist.
You may not qualify if:
- Pregnancy or breastfeeding;
- Skin pathology in the area of application of the product;
- Diabetes Mellitus type 1; insulin-dependent diabetes; presence of complications due to diabetes (retinopathy, nephropathy, neuropathy); presence of diabetes-related dermatoses (plantar ulcer, lipoid necrobiosis, annular granuloma, opportunistic infections); history of episodes of hypoglycemia, diabetic ketoacidosis and/or hyperosmolar coma;
- Current use of the following medications for topical or systemic use:
- corticosteroids, immunosuppressants and antihistamines;
- Skin diseases: vitiligo, psoriasis, lupus, atopic dermatitis;
- History of reaction to the category of the tested product;
- Other diseases or medications that may directly interfere with the study or endanger the health of the research participant.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Allergisa Pesquisa Dermato-Cosmética Ltda
Campinas, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 26, 2020
First Posted
March 31, 2020
Study Start
November 6, 2019
Primary Completion
December 10, 2019
Study Completion
February 21, 2020
Last Updated
April 3, 2020
Record last verified: 2020-04