CClinicalTrials.gg
CompletedNCT07533474Updated Apr 16, 2026

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

An interventional study of Depigmentig cosmetic product in Skin Aging, Dry Skin, sponsored by i+Med S.Coop.. Completed at 1 site in Spain. Open to female participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-16.

Sponsored by i+Med S.Coop. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Skin Aging, Dry Skin

Keywords

  • menopause
  • cosmetic
  • Tissue regeneration
  • Skin Hydration
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts 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
  • Adequate cultural level and understanding of the clinical study
  • To agree to participate voluntarily in the study and grant written Informed Consent.

Exclusion criteria

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    GYNED Depigmenting

    Other: Depigmentig cosmetic product

Interventions

  • OtherDepigmentig 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.

05

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 21 days (end of study)

  2. 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).

    Time frame: 21 days (end of study)

  3. 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).

    Time frame: 21 days (end of study)

  4. 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).

    Time frame: 21 days (end of study)

  5. 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).

    Time frame: 21 days (end of study)

  6. 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).

    Time frame: 21 days (end of study)

  7. 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).

    Time frame: 21 days (end of study)

  8. 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).

    Time frame: 21 days (end of study)

Secondary outcomes

  1. 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.

    Time frame: 21 days (end of study)

  2. SUBJECTIVE Safety Assessment (Adverse reactions recording)

    Assessment of adverse reactions observed by the volunteers

    Time frame: 21 days (end of study)

06

Study locations

1 site
  • Anmar Clinical Services, S.L.U.
    Pamplona, Navarre 31003, Spain
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07533474
Lead sponsor
i+Med S.Coop.
Responsible party
Sponsor
First posted
Apr 16, 2026
Start date
Jun 13, 2024
Primary completion
Jul 4, 2024
Completion
Jul 4, 2024
Last update
Apr 16, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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