Human In Use Test of GINHI-HP-009 in Healthy Adults (NCT07533461) | Clinical Trial Compass
CompletedNot Applicable
Human In Use Test of GINHI-HP-009 in Healthy Adults
Spain20 participantsStarted 2024-06-13
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.