HygienePhase 3NCT01158365
Dermacyd in Odor Reducing.
A Phase 3 study testing LACTIC ACID (Dermacid) and Glycerine Vegetal Soap Granado Traditional in people with Hygiene, run by Sanofi at 1 site in Brazil.
Trial summary
Primary Objective: To prove the efficacy superiority in reducing the genital odor and increase hydration in mucosa genital comparing the use of Dermacyd (different fragrances) and Glycerine Vegetal Soap Granado Traditional Secondary Objective: To evaluate the safety in normal conditions of use, verifying clinical… 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
- Hygiene
- What is being tested?
- LACTIC ACID (Dermacid) and Glycerine Vegetal Soap Granado Traditional
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2010to Dec 2010
- Phase
- Phase 3
- 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
- Perfect mucosa in the product analysis region
- Volunteers with active sexual life: normal Papanicolau test performed less than one year is mandatory
- Bacterioscopy describing the vaginal flora
- Negative Trichomonas vaginalis test
- Negative Whiff test
- Willingness in using preservative in the sexual intercourse during the study period
- Use the same category cosmetics products
- Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion
Who cannot join
- Use of antiinflammatory / immunosuppression / antihistaminic drugs
- Atopic or allergy history to cosmetic products
- Active cutaneous disease (local and/or disseminated) in the evaluated area
- Disease which can cause immunosuppression, such as diabetes, HIV, etc.
- Endocrine pathology such as thyroid disease, ovarian or adrenal gland disturbs
- Intense solar exposure (to get a tan) during the 15 days before the evaluation
Show all 10Show fewer
- Gynecologic treatment until four weeks before the evaluation
- Any vaginal infection detected during the inclusion
- Other conditions considered by the investigator as reasonable for exclude the patient in the study.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Sanofi-Aventis Investigational Site Number 076-001
Osasco, 06023-000
About this study
Official title: Single Center, Open, Cross-over, Phase III Study for Comparative Evaluation of Safety Use and Efficacy in the Odor Reduce and Vaginal Moisturize Increase for Intimates Use Products Dermacyd Femina Delicata, Dermacyd Femina Breeze, Dermacyd Teen Sweet Flower, Dermacyd Teen Fresh Mix and Dermacyd Femina Comparing to the Control Product Glycerine Vegetal Soap Granado Traditional.
Primary Objective:
- To prove the efficacy superiority in reducing the genital odor and increase hydration in mucosa genital comparing the use of Dermacyd (different fragrances) and Glycerine Vegetal Soap Granado Traditional
Secondary Objective:
- To evaluate the safety in normal conditions of use, verifying clinical signs and lab exams.
- Conditions
- Hygiene
- Being tested
- LACTIC ACID (Dermacid), Glycerine Vegetal Soap Granado Traditional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LACTIC ACID (Dermacid)Drug
Route of administration: local
Glycerine Vegetal Soap Granado TraditionalDrug
Route of administration: local
| Study group | Role | What they receive |
|---|---|---|
| Dermacyd (different fragrances) | Experimental | Day 1 until 30: Investigational Product (Dermacyd) Day 31 until 37: wash-out Day 38 until 67: Glycerine Vegetal Soap Granado Traditional Receives: Drug: LACTIC ACID (Dermacid); Drug: Glycerine Vegetal Soap Granado Traditional |
| Glycerine Vegetal Soap Granado Traditional | Active comparator | Day 1 until 30: Glycerine Vegetal Soap Granado Traditional Day 31 until 37: wash-out Day 38 until 67: Investigational Product (Dermacyd) Receives: Drug: LACTIC ACID (Dermacid); Drug: Glycerine Vegetal Soap Granado Traditional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of genital odor and increase hydration in genital mucosa
Patient's questionnaire will be completed at V1, V2 and V4. Reduction of vaginal odor, increase in the moisture area, and perception about some items like foam, facility of rinsing, final touch of the mucosa, final fragrance, and cleaning sensation will be rated on a 5-point scale.
Measured: From the treatment start to the end of the study (day 67)
Secondary outcomes (1)
Evaluation of the integrity of the mucosa
Onset of erythema, edema, scaling, blisters or other clinical sign will be evaluated.
Measured: From the treatment start to the end of the study (day 67)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HygieneStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01158365
- Sponsor's protocol ID
- LACAC_L_05401
- Other IDs
- U1111-1115-3484
- Status last verified
- Jan 2011
- First submitted
- 7 Jul 2010
- Last updated
- 4 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Center, Open, Cross-over, Phase III Study for Comparative Evaluation of Safety Use and Efficacy in the Odor Reduce and Vaginal Moisturize Increase for Intimates Use Products Dermacyd Femina Delicata, Dermacyd Femina Breeze, Dermacyd Teen Sweet Flower, Dermacyd Teen Fresh Mix and Dermacyd Femina Comparing to the Control Product Glycerine Vegetal Soap Granado Traditional.
- ClinicalTrials.gov ID
- NCT01158365
- Acronym / sponsor ID
- LACAC_L_05401
- Conditions
- Hygiene
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 8 Jul 2010 (estimated)
- 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.
Primary Objective:
- To prove the efficacy superiority in reducing the genital odor and increase hydration in mucosa genital comparing the use of Dermacyd (different fragrances) and Glycerine Vegetal Soap Granado Traditional
Secondary Objective:
- To evaluate the safety in normal conditions of use, verifying clinical signs and lab exams.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dermacyd (different fragrances) | Experimental | Drug: LACTIC ACID (Dermacid), Drug: Glycerine Vegetal Soap Granado TraditionalDay 1 until 30: Investigational Product (Dermacyd) Day 31 until 37: wash-out Day 38 until 67: Glycerine Vegetal Soap Granado Traditional |
| Glycerine Vegetal Soap Granado Traditional | Active comparator | Drug: LACTIC ACID (Dermacid), Drug: Glycerine Vegetal Soap Granado TraditionalDay 1 until 30: Glycerine Vegetal Soap Granado Traditional Day 31 until 37: wash-out Day 38 until 67: Investigational Product (Dermacyd) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Perfect mucosa in the product analysis region
- Volunteers with active sexual life: normal Papanicolau test performed less than one year is mandatory
- Bacterioscopy describing the vaginal flora
- Negative Trichomonas vaginalis test
- Negative Whiff test
Key exclusion criteria (10 listed)
- Use of antiinflammatory / immunosuppression / antihistaminic drugs
- Atopic or allergy history to cosmetic products
- Active cutaneous disease (local and/or disseminated) in the evaluated area
- Disease which can cause immunosuppression, such as diabetes, HIV, etc.
- Endocrine pathology such as thyroid disease, ovarian or adrenal gland disturbs
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 |
|---|---|---|
| LACTIC ACID (Dermacid)Route of administration: local | Drug | Dermacyd (different fragrances), Glycerine Vegetal Soap Granado Traditional |
| Glycerine Vegetal Soap Granado TraditionalRoute of administration: local | Drug | Dermacyd (different fragrances), Glycerine Vegetal Soap Granado Traditional |
Primary outcome
Reduction of genital odor and increase hydration in genital mucosa
Time frame: From the treatment start to the end of the study (day 67)
Patient's questionnaire will be completed at V1, V2 and V4. Reduction of vaginal odor, increase in the moisture area, and perception about some items like foam, facility of rinsing, final touch of the mucosa, final fragrance, and cleaning sensation will be rated on a 5-point scale.
1 secondary outcome
Evaluation of the integrity of the mucosa
Time frame: From the treatment start to the end of the study (day 67)
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 4 Jan 2011.
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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.
Clinical Sciences & Operations study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LACTIC ACID (Dermacid) and Glycerine Vegetal Soap Granado Traditional in people with Hygiene, run by Sanofi 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 10 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 4 Jan 2011. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Reduction of genital odor and increase hydration in genital mucosa (time frame: From the treatment start to the end of the study (day 67)). 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 4 Jan 2011.