Clinical trial NCT06353945: Perceived Effectiveness of the Vaginal Moisturizer Investigational Product Under Normal Conditions of Use.
Official title: Perceived Effectiveness of the Vaginal Moisturizer Investigational Product Under Normal Conditions of Use.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaginal Atrophy
Lead sponsor: Herbarium Laboratorio Botanico Ltda
Sponsor class: INDUSTRY
First posted: 2024-04-09
Enrollment: 45
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The present research project aims to evaluate the perceived effectiveness of the product under investigation under normal conditions of use for 28 days, to defend the claims "High hydration power, relief of discomfort and improvement of vaginal tone."

Detailed description: This research project aims to evaluate the perceived efficacy of the product under investigation under normal conditions of use for 28 days, to defend the attributes expected for this product category. The study will be carried out through the application of questionnaires, which will be answered by the participants. The study will be conducted with a Brazilian sample in which 45 research participants will be included.

Eligibility criteria: Inclusion Criteria:

1. Age range between 25 and 70 years old.
2. Phototypes: I to IV, according to Fitzpatrick classification;
3. Sex: female
4. Intact skin in the evaluation region.
5. Participants complaining of vaginal dryness;
6. Agree to adhere to the study procedures and requirements: study time, return(s) to the laboratory to perform study procedures, home use of the investigational product, filling out the usage diary, not changing cosmetic habits during the study period .
7. Agree not to carry out dermatological or aesthetic treatments until the end of the study and agree not to use any products from the same category as the investigational product.
8. Signing of the Free and Informed Consent Form (TCLE).

Exclusion Criteria:

1. Pregnant or breastfeeding women.
2. Skin marks in the experimental area that interfere with the assessment of possible skin reactions.
3. Active dermatoses (local or disseminated) that could interfere with the study results.
4. History of ineffectiveness, allergic reactions, irritation or intense sensation of discomfort to topical products: health products or medications.
5. Expected vaccination during the study or up to 3 weeks before the study;
6. Not taking vitamin A (acid and/or its derivatives orally or topically up to 1 month before the start of the study.)
7. Patients with immunodeficiencies.
8. History of atopy (atopic dermatitis, allergic rhinitis, allergic bronchitis, allergic conjunctivitis, etc.).
9. Use of non-steroidal anti-inflammatory drugs, corticosteroids, antihistamines, photosensitizers or immunosuppressants up to 2 weeks before the study (or considering depot corticosteroids, the interval should be 1 month before the selection).
10. Aesthetic or dermatological treatment up to 4 weeks before the study.
11. Hormonal treatments not stable in the last 3 months.
12. Hyperpigmentation associated with the use of drugs such as tetracyclines, phenothiazides or amiodarone.
13. Hyperpigmentation associated with photosensitivity.
14. People directly involved in carrying out this study and their families.
15. History of lack of adherence or unwillingness to adhere to the study protocol.
16. Any condition that, in the researcher's opinion, could compromise the study.
17. Be participating in another study in the same region of application.

Primary outcomes:
measure: evaluate the perceived effectiveness of the investigational product
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Kosmoscience Ciência e Tecnologia Cosmética Ltda
state: São Paulo
Study officials:
References: