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

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."

Study Overview

• Status: Not yet recruiting
• Conditions: Vaginal Atrophy
• Intervention / Treatment: Device: vaginal moisturizer

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.

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: vaginal moisturizer; 40 participants treated with vaginal moisturizer	Device: vaginal moisturizer; vaginal moisturizer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Herbarium Laboratorio Botanico Ltda

Study record dates

Study Major Dates

• Study Start (Estimated): April 29, 2024
• Primary Completion (Estimated): May 7, 2024
• Study Completion (Estimated): May 15, 2024

Study Registration Dates

• First Submitted: March 28, 2024
• First Submitted That Met QC Criteria: April 4, 2024
• First Posted (Actual): April 9, 2024

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy
• Other Study ID Numbers: HB062-24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No