Human In Use Test of GINPI-HP-004 in Healthy Adults

i+Med S.Coop.20 enrolled

Overview

The main objective of this study was to confirm skin acceptability of the product GINPI REF. GINPI BATCH: 10/06/2024 applied under normal use conditions 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

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Skin Aging, Dry Skin

Interventions

Depigmentig cosmetic productOTHER

Apply the cosmetic product at night, one or two pumps until the area to be treated is covered. Massage the vulvar area until completely absorbed.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 * 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.

Locations (1)

Anmar Clinical Services, S.L.U.

Pamplona, Navarre, Spain

Outcomes

Primary Outcomes

Efficacy evaluation (volunteer)

Evaluation of the soothing and moisturizing of the cosmetic product by the volunteers by means of a 4 point questionnaire (4 = Fully Agree / 1= Strongly Dissagre).