The main objective of this study was to confirm skin acceptability of the product GINPI REF. GINHI BATCH: 10/06/2024 applied under normal use conditions, twice a day, in healthy female adult volunteers, under gynecological control, by means of the evaluation of organoleptic characteristics and subjective efficacy of the study product by the volunteers. Other (secondary) objective was the assessment of unexpected adverse events referred by the volunteers as well as possible reactions observed by the investigator.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Distribute cosmetic product evenly in the morning and evening (or when necessary), one dose on the external intimate area.
Anmar Clinical Services, S.L.U.
Pamplona, Navarre, Spain
Efficacy evaluation (volunteer)
Evaluation of the prevention of the vaginal dryness by the volunteers by means of a 4 point questionnaire (4 = Fully Agree / 1= Strongly Dissagre).
Time frame: 21 days (end of study)
Efficacy evaluation (volunteer)
Evaluation of the prevention of the onset of discomfort and itching by the volunteers by means of a 4 point questionnaire (4 = Fully Agree / 1= Strongly Dissagre).
Time frame: 21 days (end of study)
Efficacy evaluation (volunteer)
Evaluation of the increasing of the natural female lubrication by the volunteers by means of a 4 point questionnaire (4 = Fully Agree / 1= Strongly Dissagre).
Time frame: 21 days (end of study)
Efficacy evaluation (volunteer)
Evaluation of the soothing and moisturizing of the vulvar area of the product by the volunteers by means of a 4 point questionnaire (4 = Fully Agree / 1= Strongly Dissagre).
Time frame: 21 days (end of study)
Efficacy evaluation (volunteer)
Evaluation of the suitability for daily use of the product by the volunteers by means of a 4 point questionnaire (4 = Fully Agree / 1= Strongly Dissagre).
Time frame: 21 days (end of study)
Organoleptic properties evaluation (volunteer)
Evaluation of the opinion of the appearance by means of a 4 point questionnaire (4 = I like it a lot / 1= I don't like it at all).
Time frame: 21 days (end of study)
Organoleptic properties evaluation (volunteer)
Evaluation of the opinion of the texture of the product by means of a 4 point questionnaire (4 = I like it a lot / 1= I don't like it at all).
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Time frame: 21 days (end of study)
Organoleptic properties evaluation (volunteer)
Evaluation of the opinion of the smell of the product by means of a 4 point questionnaire (4 = I like it a lot / 1= I don't like it at all).
Time frame: 21 days (end of study)
OBJECTIVE Safety Assessment (Adverse reactions recording)
Presence or absence of adverse reactions considered as undesirable effects related with the study product, according to the assessment performed by the principal investigator, using descriptive analysis of frequencies.
Time frame: 21 days (end of study)
SUBJECTIVE Safety Assessment (Adverse reactions recording)
Assessment of adverse reactions observed by the volunteers
Time frame: 21 days (end of study)