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

NCT07533474 | Completed

• 1 other identifier: HUT_UNI_24_02
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Skin Aging, Dry Skin

Keywords

menopause; cosmetic; Tissue regeneration; Skin Hydration

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (2)

• OBJECTIVE Safety Assessment (Adverse reactions recording)

  21 days (end of study)

• SUBJECTIVE Safety Assessment (Adverse reactions recording)

  21 days (end of study)

Study Arms (1)

GYNED Depigmenting

EXPERIMENTAL

Other: Depigmentig cosmetic product

Interventions

Depigmentig cosmetic product OTHER

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.

GYNED Depigmenting

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• i+Med S.Coop.: lead

Study Sites (1)

Anmar Clinical Services, S.L.U.

Pamplona, Navarre, 31003, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 16, 2026
• Study Start: June 13, 2024
• Primary Completion: July 4, 2024
• Study Completion: July 4, 2024
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)