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Completed

NCT Number: NCT07533461

Human In Use Test of GINHI-HP-009 in Healthy Adults

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

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Key information

Conditions

Skin Aging, Dry Skin

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Anmar Clinical Services, S.L.U.

Pamplona, Navarre, 31003, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • Frequent users of similar product
  • 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.

Treatment and study plan

Lubricating cosmetic product

Other

Distribute cosmetic product evenly in the morning and evening (or when necessary), one dose on the external intimate area.

Primary outcomes

  1. Efficacy evaluation (volunteer)

    Time frame: 21 days (end of study)

    Evaluation of the prevention of the vaginal dryness by the volunteers by means of a 4 point questionnaire (4 = Fully Agree / 1= Strongly Dissagre).

  2. Efficacy evaluation (volunteer)

    Time frame: 21 days (end of study)

    Evaluation of the prevention of the onset of discomfort and itching by the volunteers by means of a 4 point questionnaire (4 = Fully Agree / 1= Strongly Dissagre).

  3. Efficacy evaluation (volunteer)

    Time frame: 21 days (end of study)

    Evaluation of the increasing of the natural female lubrication by the volunteers by means of a 4 point questionnaire (4 = Fully Agree / 1= Strongly Dissagre).

  4. Efficacy evaluation (volunteer)

    Time frame: 21 days (end of study)

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

  5. 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).

  6. 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).

  7. 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).

  8. 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).

Secondary outcomes

  1. 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.

  2. SUBJECTIVE Safety Assessment (Adverse reactions recording)

    Time frame: 21 days (end of study)

    Assessment of adverse reactions observed by the volunteers

Sponsors and collaborators

Lead sponsor

i+Med S.Coop.

Industry

Registry information

Official study title

Safety Human in Use Test Under Gynecological Control for the Appreciation of Skin Acceptability of the Product GINHI REF. GINHI BATCH: 10/06/2024 in Healthy Female Adult Volunteers

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 16, 2026
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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