Skin Aging, Dry Skin
Conditions
Keywords
menopause, Skin lubrication, Skin hydration
Brief summary
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.
Interventions
OTHERLubricating cosmetic product
Distribute cosmetic product evenly in the morning and evening (or when necessary), one dose on the external intimate area.
Sponsors
i+Med S.Coop.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy women * Age between 18 and 65 years * Volunteers with sensitive skin (50%) and normal skin (50%) * Volunteers with Fitzpatrick skin photo-type I to IV * Frequent users of similar product * Adequate cultural level and understanding of the clinical study * To agree to participate voluntarily in the study and grant written Informed Consent.
Exclusion criteria
* Volunteers with chronic or acute disease at study initiation or in the last 3 weeks prior to inclusion * Volunteers with skin pathologies in the last 3 weeks prior to study initiation. * Volunteers under pharmacological treatment. * Pregnant or breast-feeding women. * Volunteers with allergy to any of the study product components. * Vaccinated in the last 3 weeks previous to study start.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy evaluation (volunteer) | 21 days (end of study) | Evaluation of the prevention of the vaginal dryness by the volunteers by means of a 4 point questionnaire (4 = Fully Agree / 1= Strongly Dissagre). |
| Organoleptic properties evaluation (volunteer) | 21 days (end of study) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OBJECTIVE Safety Assessment (Adverse reactions recording) | 21 days (end of study) | 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. |
| SUBJECTIVE Safety Assessment (Adverse reactions recording) | 21 days (end of study) | Assessment of adverse reactions observed by the volunteers |
Countries
Spain
Outcome results
None listed