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

SAFETY HUMAN IN USE TEST UNDER GYNECOLOGICAL CONTROL FOR THE APPRECIATION OF SKIN ACCEPTABILITY OF THE PRODUCT GINPI REF. GINPI BATCH: 10/06/2024 IN HEALTHY FEMALE ADULT VOLUNTEERS

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 Overview

• Status: Completed
• Conditions: Skin Aging, Dry Skin
• Intervention / Treatment: Other: Depigmentig cosmetic product

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Navarre
    • Pamplona, Navarre, Spain, 31003
      • Anmar Clinical Services, S.L.U.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GYNED Depigmenting	Other: Depigmentig cosmetic product; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	21 days (end of study)
Efficacy evaluation (volunteer)	Evaluation of the firmness of the tissue of the intimate area of the cosmetic product by the volunteers by means of a 4 point questionnaire (4 = Fully Agree / 1= Strongly Dissagre).	21 days (end of study)
Efficacy evaluation (volunteer)	Evaluation of the equalization of the skin tone by the depigmentacion of the product by the volunteers by means of a 4 point questionnaire (4 = Fully Agree / 1= Strongly Dissagre).	21 days (end of study)
Efficacy evaluation (volunteer)	Evaluation of the corrective and regulation action on the intimate area of the product by the volunteers by means of a 4 point questionnaire (4 = Fully Agree / 1= Strongly Dissagre).	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).	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).	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).	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).	21 days (end of study)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	21 days (end of study)
SUBJECTIVE Safety Assessment (Adverse reactions recording)	Assessment of adverse reactions observed by the volunteers	21 days (end of study)

Collaborators and Investigators

• Sponsor: i+Med S.Coop.

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2024
• Primary Completion (Actual): July 4, 2024
• Study Completion (Actual): July 4, 2024

Study Registration Dates

• First Submitted: April 7, 2026
• First Submitted That Met QC Criteria: April 14, 2026
• First Posted (Actual): April 16, 2026

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: menopause; cosmetic; Tissue regeneration; Skin Hydration
• Other Study ID Numbers: HUT_UNI_24_02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No