Safety Test Under Gynecological Control to Evaluate Skin Acceptability of the Product in Female Volunteers

NCT07533461 | Completed

• 1 other identifier: HUT_UNI_24_01
• 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. 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.

Conditions

Skin Aging, Dry Skin

Keywords

menopause; Skin lubrication; Skin hydration

Outcome Measures

Primary Outcomes (8)

• Efficacy evaluation (volunteer)

  Evaluation of the prevention of the vaginal dryness 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 prevention of the onset of discomfort and itching 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 increasing of the natural female lubrication 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 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).

  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 Lubricant

EXPERIMENTAL

Other: Lubricating cosmetic product

Interventions

Lubricating cosmetic product OTHER

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

GYNED Lubricant

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
• 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.

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)