Vaginal AtrophyNCT06353945
Perceived Effectiveness of the Vaginal Moisturizer Investigational Product Under Normal Conditions of Use.
A study testing vaginal moisturizer in people with Vaginal Atrophy, run by Herbarium Laboratorio Botanico Ltda at 1 site in Brazil.
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." Read more about this study
- Who is it for?
- Ages 25 to 70 years, women only
- Conditions the study is for
- Vaginal Atrophy
- What is being tested?
- vaginal moisturizer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Jun 2024to 18 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 25 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age range between 25 and 70 years old.
- Phototypes: I to IV, according to Fitzpatrick classification;
- Sex: female
- Intact skin in the evaluation region.
- Participants complaining of vaginal dryness;
- 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 .
- 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.
- Signing of the Free and Informed Consent Form (TCLE).
Who cannot join
- Pregnant or breastfeeding women.
- Skin marks in the experimental area that interfere with the assessment of possible skin reactions.
- Active dermatoses (local or disseminated) that could interfere with the study results.
- History of ineffectiveness, allergic reactions, irritation or intense sensation of discomfort to topical products: health products or medications.
- Expected vaccination during the study or up to 3 weeks before the study;
- Not taking vitamin A (acid and/or its derivatives orally or topically up to 1 month before the start of the study.)
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- Patients with immunodeficiencies.
- History of atopy (atopic dermatitis, allergic rhinitis, allergic bronchitis, allergic conjunctivitis, etc.).
- 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).
- Aesthetic or dermatological treatment up to 4 weeks before the study.
- Hormonal treatments not stable in the last 3 months.
- Hyperpigmentation associated with the use of drugs such as tetracyclines, phenothiazides or amiodarone.
- Hyperpigmentation associated with photosensitivity.
- People directly involved in carrying out this study and their families.
- History of lack of adherence or unwillingness to adhere to the study protocol.
- Any condition that, in the researcher's opinion, could compromise the study.
- Be participating in another study in the same region of application.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Kosmoscience Ciência e Tecnologia Cosmética Ltda
Campinas, São Paulo, 13041-315
About this study
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."
Read the 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.
- Conditions
- Vaginal Atrophy
- Being tested
- vaginal moisturizer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vaginal moisturizerDevice
vaginal moisturizer
| Study group | Role | What they receive |
|---|---|---|
| vaginal moisturizer | Experimental | 45 participants treated with vaginal moisturizer Receives: Device: vaginal moisturizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start10 Jun 2024
- Primary completion10 Jul 2024
- Study completion18 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal AtrophyStudies 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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herbarium Laboratorio Botanico Ltda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06353945
- Sponsor's protocol ID
- HB062-24
- Status last verified
- Nov 2024
- First submitted
- 28 Mar 2024
- Last updated
- 18 Nov 2024
- 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 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perceived Effectiveness of the Vaginal Moisturizer Investigational Product Under Normal Conditions of Use.
- ClinicalTrials.gov ID
- NCT06353945
- Acronym / sponsor ID
- HB062-24
- Conditions
- Vaginal Atrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Herbarium Laboratorio Botanico LtdaIndustry (pharma, biotech, devices)
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- 10 Jul 2024 (actual)
- Study completion
- 18 Jul 2024 (actual)
- First posted
- 9 Apr 2024 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| vaginal moisturizer | Experimental | Device: vaginal moisturizer45 participants treated with vaginal moisturizer |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age range between 25 and 70 years old.
- Phototypes: I to IV, according to Fitzpatrick classification;
- Sex: female
- Intact skin in the evaluation region.
- Participants complaining of vaginal dryness;
Key exclusion criteria (17 listed)
- Pregnant or breastfeeding women.
- Skin marks in the experimental area that interfere with the assessment of possible skin reactions.
- Active dermatoses (local or disseminated) that could interfere with the study results.
- History of ineffectiveness, allergic reactions, irritation or intense sensation of discomfort to topical products: health products or medications.
- Expected vaccination during the study or up to 3 weeks before the study;
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 |
|---|---|---|
| vaginal moisturizervaginal moisturizer | Device | vaginal moisturizer |
Primary outcome
evaluate the perceived effectiveness of the investigational product
Time frame: 28 days
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.
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 18 Nov 2024.
- 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 vaginal moisturizer in people with Vaginal Atrophy, run by Herbarium Laboratorio Botanico Ltda at 1 site in Brazil.
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 8 inclusion and 17 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 18 Nov 2024. 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 Brazil. 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?
evaluate the perceived effectiveness of the investigational product (time frame: 28 days). 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 18 Nov 2024.