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The main objective of this study was to confirm skin acceptability of the product GINPI REF. GINPI BATCH: 10/06/2024 applied under normal use conditions 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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GYNED Depigmenting | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Depigmentig cosmetic product | Other | Apply the cosmetic product at night, one or two pumps until the area to be treated is covered. Massage the vulvar area until completely absorbed. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy evaluation (volunteer) | Evaluation of the soothing and moisturizing of the cosmetic 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 firmness of the tissue of the intimate area of the cosmetic 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 equalization of the skin tone by the depigmentacion 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 corrective and regulation action on the intimate 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 21 days (end of study) |
| SUBJECTIVE Safety Assessment (Adverse reactions recording) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anmar Clinical Services, S.L.U. | Pamplona | Navarre | 31003 | Spain |
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| 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) |
Assessment of adverse reactions observed by the volunteers |
| 21 days (end of study) |