Perceived Effectiveness of the Vaginal Moisturizer Investigational Product Under Normal Conditions of Use.

Vaginal Atrophy Clinical Trial

Official title:

Perceived Effectiveness of the Vaginal Moisturizer Investigational Product Under Normal Conditions of Use.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06353945
• Other study ID #: HB062-24
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 29, 2024
• Est. completion date: May 15, 2024

Study information

• Verified date: March 2024
• Source: Herbarium Laboratorio Botanico Ltda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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."

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: May 15, 2024
• Est. primary completion date: May 7, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrophy
• Vaginal Atrophy

Intervention

Device:
• vaginal moisturizer
vaginal moisturizer

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Herbarium Laboratorio Botanico Ltda

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	evaluate the perceived effectiveness of the investigational product	The perceived efficacy of the subjective method will be evaluated by means of questionnaires answered by the research participants after the first use and 28 days of use of the investigational product using a rating scale. The results of this evaluation will be used to analyze the frequency of scores for each attribute evaluated. Based on the results of the evaluation of the product's efficacy, an analysis of the frequency of scores for each question evaluated.	28 days