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

What this trial studies

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 in scope

• Skin Aging, Dry Skin

Interventions

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

Who can join

Women only · Ages 18 Years to 65 Years · Accepts healthy volunteers.

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.

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Completed
• Study type: Interventional
• Phase: N/A
• Start date: 2024-06-13
• Primary completion: 2024-07-04
• Last update posted: 2026-04-21
• First posted: 2026-04-16

Sponsor & contact

Lead sponsor: i+Med S.Coop. (Industry)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Efficacy evaluation (volunteer) (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).
• Efficacy evaluation (volunteer) (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).
• Efficacy evaluation (volunteer) (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).
• Efficacy evaluation (volunteer) (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).
• Efficacy evaluation (volunteer) (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).

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