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

April 14, 2026 updated by: i+Med S.Coop.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Efficacy evaluation (volunteer)
Time Frame: 21 days (end of study)
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)
Time Frame: 21 days (end of study)
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)
Time Frame: 21 days (end of study)
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)
Time Frame: 21 days (end of study)
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)
Time Frame: 21 days (end of study)
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)
Time Frame: 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).
21 days (end of study)
Organoleptic properties evaluation (volunteer)
Time Frame: 21 days (end of study)
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)
Time Frame: 21 days (end of study)
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
OBJECTIVE Safety Assessment (Adverse reactions recording)
Time Frame: 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.
21 days (end of study)
SUBJECTIVE Safety Assessment (Adverse reactions recording)
Time Frame: 21 days (end of study)
Assessment of adverse reactions observed by the volunteers
21 days (end of study)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
i+Med S.Coop.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 13, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 4, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 4, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 7, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 16, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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