HygienePhase 3NCT01126606
Comparative Safety and Efficacy Evaluation Between Dermacyd Silver and Glycerine Vegetal Soap Granado Traditional
A Phase 3 study testing Dermacid Silver (Lactic acid) and Glycerine Vegetal Soap Granado Traditional in people with Hygiene, run by Sanofi at 1 site in Brazil.
Trial summary
Primary Objective: To evaluate the potential of hydratation and renewal of the mucosa, through corneometry measurement and individual questionnaire perception. Secondary Objective: To evaluate the safety in normal condition of use. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Hygiene
- What is being tested?
- Dermacid Silver (Lactic acid) and Glycerine Vegetal Soap Granado Traditional
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2010to Nov 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 45 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Active sex life
- Menopause for at least 6 months
- Perfect mucosa in the evaluated area
- Use the same cosmetics category
Who cannot join
- Use of antiinflammatory / immunosuppression / antihistaminic drugs
- Personal history of atopy to cosmetic products
- Cutaneous active disease (local and/or general) in the evaluated area
- Disease which can cause immunosuppression, such as diabetes, HIV
- Endocrine pathology such as thyroid disease, ovarian disorder or adrenal gland
- Intense solar exposure (to get a tan) during the 15 days before the evaluation
Show all 10Show fewer
- Gynaecologic treatment until four weeks before the evaluation
- Whatever vaginal infection detected at time of inclusion
- Other conditions considered by the investigator as reasonable to exclude the patient from 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.
About this study
Official title: Single Center, Open, Cross-over, Phase III Study for Safety and Efficacy (Subjective and Instrumental) Comparative Evaluation Between Dermacyd Silver and Glycerine Vegetal Soap Granado Traditional for Intimate Use in Menopauses Woman.
Primary Objective:
To evaluate the potential of hydratation and renewal of the mucosa, through corneometry measurement and individual questionnaire perception.
Secondary Objective:
To evaluate the safety in normal condition of use.
- Conditions
- Hygiene
- Being tested
- Dermacid Silver (Lactic acid), Glycerine Vegetal Soap Granado Traditional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dermacid Silver (Lactic acid)Drug
Liquid soap, daily use
Glycerine Vegetal Soap Granado TraditionalDrug
Vegetal soap, daily use
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Dermacyd Silver Frutal followed by Dermacyd Silver Frutal+PH_DESYLSTY_FR followed by wash out followed by Glycerine Vegetal Soap Granado Traditional Receives: Drug: Dermacid Silver (Lactic acid); Drug: Glycerine Vegetal Soap Granado Traditional |
| Group 2 | Experimental | Glycerine Vegetal Soap Granado Traditional followed by wash out followed by Dermacyd Silver Floral followed by Dermacyd Silver Floral + PH_DESYLSTY_FR Receives: Drug: Dermacid Silver (Lactic acid); Drug: Glycerine Vegetal Soap Granado Traditional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transepidermal water loss measurement (TEWL) and corneometry
Measures taken at all visits by Tewameter equipment TM 300. The value of the average will be considered for analysis of final results.
Corneometry: Measures taken at all visits by Corneometer equipment MPA 580.
Measured: Up to Week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2010 (estimated)
- Study startAug 2010
- Primary completionNov 2010
- Study completionNov 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
- 70 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
- NCT01126606
- Sponsor's protocol ID
- LACAC_L_04937
- Status last verified
- Dec 2010
- First submitted
- 17 May 2010
- Last updated
- 2 Dec 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Center, Open, Cross-over, Phase III Study for Safety and Efficacy (Subjective and Instrumental) Comparative Evaluation Between Dermacyd Silver and Glycerine Vegetal Soap Granado Traditional for Intimate Use in Menopauses Woman.
- ClinicalTrials.gov ID
- NCT01126606
- Acronym / sponsor ID
- LACAC_L_04937
- Conditions
- Hygiene
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 19 May 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 evaluate the potential of hydratation and renewal of the mucosa, through corneometry measurement and individual questionnaire perception.
Secondary Objective:
To evaluate the safety in normal condition of use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Dermacid Silver (Lactic acid), Drug: Glycerine Vegetal Soap Granado TraditionalDermacyd Silver Frutal followed by Dermacyd Silver Frutal+PH_DESYLSTY_FR followed by wash out followed by Glycerine Vegetal Soap Granado Traditional |
| Group 2 | Experimental | Drug: Dermacid Silver (Lactic acid), Drug: Glycerine Vegetal Soap Granado TraditionalGlycerine Vegetal Soap Granado Traditional followed by wash out followed by Dermacyd Silver Floral followed by Dermacyd Silver Floral + PH_DESYLSTY_FR |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Active sex life
- Menopause for at least 6 months
- Perfect mucosa in the evaluated area
- Use the same cosmetics category
Key exclusion criteria (10 listed)
- Use of antiinflammatory / immunosuppression / antihistaminic drugs
- Personal history of atopy to cosmetic products
- Cutaneous active disease (local and/or general) in the evaluated area
- Disease which can cause immunosuppression, such as diabetes, HIV
- Endocrine pathology such as thyroid disease, ovarian disorder or adrenal gland
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 |
|---|---|---|
| Dermacid Silver (Lactic acid)Liquid soap, daily use | Drug | Group 1, Group 2 |
| Glycerine Vegetal Soap Granado TraditionalVegetal soap, daily use | Drug | Group 1, Group 2 |
Primary outcome
Transepidermal water loss measurement (TEWL) and corneometry
Time frame: Up to Week 9
Measures taken at all visits by Tewameter equipment TM 300. The value of the average will be considered for analysis of final results. Corneometry: Measures taken at all visits by Corneometer equipment MPA 580.
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 2 Dec 2010.
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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 Dermacid Silver (Lactic acid) 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 4 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 2 Dec 2010. 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?
Transepidermal water loss measurement (TEWL) and corneometry (time frame: Up to Week 9). 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 2 Dec 2010.