Skin Aging, Dry SkinNCT07533461
Human In Use Test of GINHI-HP-009 in Healthy Adults
A study testing Lubricating cosmetic product in people with Skin Aging, Dry Skin, run by i+Med S.Coop. at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Aging, Dry Skin
- What is being tested?
- Lubricating cosmetic product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 13 Jun 2024to 4 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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
- Being tested
- Lubricating cosmetic product
- Keywords
- menopause, Skin lubrication, Skin hydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lubricating cosmetic productOther
Distribute cosmetic product evenly in the morning and evening (or when necessary), one dose on the external intimate area.
| Study group | Role | What they receive |
|---|---|---|
| GYNED Lubricant | Experimental | Not described Receives: Other: Lubricating cosmetic product |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 21 days (end of study)
Secondary outcomes (2)
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.
Measured: 21 days (end of study)
SUBJECTIVE Safety Assessment (Adverse reactions recording)
Assessment of adverse reactions observed by the volunteers
Measured: 21 days (end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start13 Jun 2024
- Primary completion4 Jul 2024
- Study completion4 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Aging, Dry SkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- i+Med S.Coop.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07533461
- Sponsor's protocol ID
- HUT_UNI_24_01
- Status last verified
- Apr 2026
- First submitted
- 7 Apr 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07533461
- Acronym / sponsor ID
- HUT_UNI_24_01
- Conditions
- Skin Aging, Dry Skin
- Keywords
- menopause, Skin lubrication, Skin hydration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- i+Med S.Coop.Industry (pharma, biotech, devices)
- Study start
- 13 Jun 2024 (actual)
- Primary completion
- 4 Jul 2024 (actual)
- Study completion
- 4 Jul 2024 (actual)
- First posted
- 16 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GYNED Lubricant | Experimental | Other: Lubricating cosmetic product |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lubricating cosmetic productDistribute cosmetic product evenly in the morning and evening (or when necessary), one dose on the external intimate area. | Other | GYNED Lubricant |
Primary outcome
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).
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).
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).
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).
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).
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).
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).
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).
2 secondary outcomes
OBJECTIVE Safety Assessment (Adverse reactions recording)
Time frame: 21 days (end of study)
SUBJECTIVE Safety Assessment (Adverse reactions recording)
Time frame: 21 days (end of study)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lubricating cosmetic product in people with Skin Aging, Dry Skin, run by i+Med S.Coop. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy evaluation (volunteer) (time frame: 21 days (end of study)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.