Vaginal Flora ImbalanceNCT06085898
Stryphnodendron Adstringens Intimate Soap
A study testing Stryphnodendron Adstringens 3% - once daily post bath in people with Vaginal Flora Imbalance, run by Biolab Sanus Farmaceutica at 1 site in Brazil.
Trial summary
This is a single-centre, single-blind, non-comparative clinical trial to assess the safety of the investigational product through clinical probability assessment. Thirty-three female participants, aged between 18-45, will be required. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Flora Imbalance
- What is being tested?
- Stryphnodendron Adstringens 3% - once daily post bath
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteBrazil
- Study dates
- 5 Nov 2023to Dec 2023
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Active and regular menstrual flow;
- Vaginal pH value between 3.8 and 4.5;
- Intact skin in the product analysis region (vaginal mucosa);
- Being a user of cosmetic products of the same category (intimate soap);
- Agreement to follow the trial procedures and attendance at the Clinical Research Center on the days and times determined for applications and/or estimates;
- Understanding, consent and signature of the Free and Informed Consent Term (TCLE).
Who cannot join
- Participants who have been diagnosed with COVID-19 in the last 4 weeks or who have symptoms such as fever, dry cough, tiredness, body aches or other discomforts;
- Pregnancy or risk of pregnancy and/or lactation;
- Being in the menstrual period;
- Use of anti-inflammatory/immunosuppressive/antihistamine drugs up to 3 weeks before selection;
- Skin marks in the experimental area that interfere with the evaluation of possible skin reactions (vascular malformations, scars, increased hairiness, large amounts of nevus, sunburn);
- Atopic or allergic history to cosmetic products;
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- Pathologies and/or active skin lesions (local and/or disseminated) in the evaluation area;
- Immunosuppression by drugs or active diseases;
- Decompensated endocrinopathies;
- Relevant medical history or current evidence of alcohol or other drug abuse;
- Known history or suspected intolerance to products of the same category;
- Aesthetic or dermatological treatment in the evaluation area up to 04 weeks before selection;
- Employees of Medcin or the sponsoring company involved in the study, or a close family member of an employee involved in the study;
- Other conditions considered by the researcher as reasonable for disqualification from participation in the study. If yes, it should be described in observation in the clinical record.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Dermal Acceptance, Gynecological and pH Maintenance With Microbiological Analysis of Vaginal Secretion for Cosmetic Product
This is a single-centre, single-blind, non-comparative clinical trial to assess the safety of the investigational product through clinical probability assessment.
Thirty-three female participants, aged between 18-45, will be required. Assessment of dermal (dermatological) and gynecological acceptance, in addition to pH measurements and vaginal force collection for microbiological analysis at the beginning and end of the study.
Read the detailed description
This is a single-centre, single-blind, non-comparative clinical trial to assess the safety of the investigational product through clinical probability assessment.
Thirty-three female participants, aged between 18-45, will be required. Assessment of dermal (dermatological) and gynecological acceptance, in addition to pH measurements and vaginal force collection for microbiological analysis at the beginning and end of the study.
Participants will remain in the study for a minimum period of 30 days, using the product for the same period according to the flow below:
Flow of Visits:
Visit 01 (D0)
- Participants' consent process after understanding the study;
- Initial assessments: safety clinics (dermatologist/gynecologist);
- Vaginal pH measurement;
- Collection of vaginal secretion;
- Dispensing of the usage diary;
- Investigational product dispensing.
Visit 02 (D30 ±2 days)
- Final assessments: clinical safety assessments (dermatologist/gynecologist);
- Vaginal pH measurement;
- Collection of vaginal secretion;
- Collection of the usage diary;
- Return of the product;
- Subjective questionnaire (self-assessment) to capture possible feelings of discomfort;
- Completion of the study.
- Conditions
- Vaginal Flora Imbalance
- Being tested
- Stryphnodendron Adstringens 3% - once daily post bath
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stryphnodendron Adstringens 3% - once daily post bathDrug
Also called Barbatimão
Intimate Soap
| Study group | Role | What they receive |
|---|---|---|
| Stryphnodendron Adstringens (Barbatimão) | Experimental | Intimate Soap Receives: Drug: Stryphnodendron Adstringens 3% - once daily post bath |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dermatological and gynecological evaluation criteria
Assess the presence of any clinical signs/symptoms in the vulva, anal and vaginal region by visually observing the mons pubis, labia majora, labia minora, clitoris, vaginal vestibule, urethral orifice, perineum and anal region, with application of a 2-point categorical scale (0=no, 1=yes)
Measured: Immediately after the intervention
Secondary outcomes (1)
Assessment
Clinical signs and/or symptoms of adverse events
Measured: Assessment of the occurrence and intensity of erythema, edema, scaling and vesiculation, using a 4-point scale (0=absent, 1=mild, 2=moderate, 3=severe)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start5 Nov 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal Flora ImbalanceStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biolab Sanus Farmaceutica
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medcin Instituto da Pele
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06085898
- Sponsor's protocol ID
- EN22-0629-01
- Status last verified
- Oct 2023
- First submitted
- 6 Jul 2023
- Last updated
- 17 Oct 2023
- 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 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Dermal Acceptance, Gynecological and pH Maintenance With Microbiological Analysis of Vaginal Secretion for Cosmetic Product
- ClinicalTrials.gov ID
- NCT06085898
- Acronym / sponsor ID
- EN22-0629-01
- Conditions
- Vaginal Flora Imbalance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Biolab Sanus FarmaceuticaIndustry (pharma, biotech, devices)
- Collaborators
- Medcin Instituto da Pele
- Study start
- 5 Nov 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 17 Oct 2023 (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.
This is a single-centre, single-blind, non-comparative clinical trial to assess the safety of the investigational product through clinical probability assessment.
Thirty-three female participants, aged between 18-45, will be required. Assessment of dermal (dermatological) and gynecological acceptance, in addition to pH measurements and vaginal force collection for microbiological analysis at the beginning and end of the study.
Detailed description
This is a single-centre, single-blind, non-comparative clinical trial to assess the safety of the investigational product through clinical probability assessment.
Thirty-three female participants, aged between 18-45, will be required. Assessment of dermal (dermatological) and gynecological acceptance, in addition to pH measurements and vaginal force collection for microbiological analysis at the beginning and end of the study.
Participants will remain in the study for a minimum period of 30 days, using the product for the same period according to the flow below:
Flow of Visits:
Visit 01 (D0)
- Participants' consent process after understanding the study;
- Initial assessments: safety clinics (dermatologist/gynecologist);
- Vaginal pH measurement;
- Collection of vaginal secretion;
- Dispensing of the usage diary;
- Investigational product dispensing.
Visit 02 (D30 ±2 days)
- Final assessments: clinical safety assessments (dermatologist/gynecologist);
- Vaginal pH measurement;
- Collection of vaginal secretion;
- Collection of the usage diary;
- Return of the product;
- Subjective questionnaire (self-assessment) to capture possible feelings of discomfort;
- Completion of the study.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stryphnodendron Adstringens (Barbatimão) | Experimental | Drug: Stryphnodendron Adstringens 3% - once daily post bathIntimate Soap |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Active and regular menstrual flow;
- Vaginal pH value between 3.8 and 4.5;
- Intact skin in the product analysis region (vaginal mucosa);
- Being a user of cosmetic products of the same category (intimate soap);
- Agreement to follow the trial procedures and attendance at the Clinical Research Center on the days and times determined for applications and/or estimates;
Key exclusion criteria (14 listed)
- Participants who have been diagnosed with COVID-19 in the last 4 weeks or who have symptoms such as fever, dry cough, tiredness, body aches or other discomforts;
- Pregnancy or risk of pregnancy and/or lactation;
- Being in the menstrual period;
- Use of anti-inflammatory/immunosuppressive/antihistamine drugs up to 3 weeks before selection;
- Skin marks in the experimental area that interfere with the evaluation of possible skin reactions (vascular malformations, scars, increased hairiness, large amounts of nevus, sunburn);
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 |
|---|---|---|
| Stryphnodendron Adstringens 3% - once daily post bathAlso: BarbatimãoIntimate Soap | Drug | Stryphnodendron Adstringens (Barbatimão) |
Primary outcome
Dermatological and gynecological evaluation criteria
Time frame: Immediately after the intervention
Assess the presence of any clinical signs/symptoms in the vulva, anal and vaginal region by visually observing the mons pubis, labia majora, labia minora, clitoris, vaginal vestibule, urethral orifice, perineum and anal region, with application of a 2-point categorical scale (0=no, 1=yes)
1 secondary outcome
Assessment
Time frame: Assessment of the occurrence and intensity of erythema, edema, scaling and vesiculation, using a 4-point scale (0=absent, 1=mild, 2=moderate, 3=severe)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stryphnodendron Adstringens 3% - once daily post bath in people with Vaginal Flora Imbalance, run by Biolab Sanus Farmaceutica 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 6 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 17 Oct 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sérgio Schalka, MD ((55) (11) 3683-5366, contato@medcinpesquisa.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dermatological and gynecological evaluation criteria (time frame: Immediately after the intervention). 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 17 Oct 2023; AzTrials last refreshed its copy on 27 Oct 2026.