HygienePhase 3NCT00933569
Dermacyd Silver Floral (Lactic Acid) - Acceptability.
A Phase 3 study testing LACTIC ACID(ND) in people with Hygiene, run by Sanofi at 1 site in Brazil.
Trial summary
Primary Objective: To prove the safety of the gynaecological formulation in normal conditions of use. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hygiene
- What is being tested?
- LACTIC ACID(ND)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2009to Jul 2009
- 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Integral vaginal mucosa in the product analysis region
- Use the same category of cosmetics products
- Willingness in following the study procedures and to be present in the clinic at the days and scheduled time
Who cannot join
- Use of Anti-inflammatory, immunossupression or antihistaminics drugs
- Allergic or atopic history to cosmetics products
- Cutaneous active disease (local and/or general) in the evaluated area
- Disease which can cause immunosuppresion, such as diabetes, HIV
- Endocrinology pathology such as thyroid gland, ovary and adrenal gland
- Intensive solar exposure until 15 days before evaluation
Show all 9Show fewer
- Gynecological treatment until four weeks before the study
- Other reason considered by the investigator as a reason for not being included.
- 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: Monocentric Study, Phase III, for Safety Dermatological Evaluation: Acceptability With Gynaecological Follow up Dermacyd Silver Floral (Lactic Acid).
Primary Objective:
To prove the safety of the gynaecological formulation in normal conditions of use.
- Conditions
- Hygiene
- Being tested
- LACTIC ACID(ND)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LACTIC ACID(ND)Drug
treatment period: 21 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Dermacyd Silver Floral (Lactic Acid) | Experimental | Aplication of Dermacyd Silver Floral (Lactic Acid) during 21 consecutive days Receives: Drug: LACTIC ACID(ND) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the absence of irritation and the good acceptability by using one specific scale which describes the intensity of the reaction.
Measured: From the treatment start to the end of the study (treatment period 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2009 (estimated)
- Study startJun 2009
- Primary completionJul 2009
- Study completionJul 2009
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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jaderson Lima, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00933569
- Sponsor's protocol ID
- LACAC_L_04838
- Status last verified
- Sep 2010
- First submitted
- 3 Jul 2009
- Last updated
- 14 Sep 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monocentric Study, Phase III, for Safety Dermatological Evaluation: Acceptability With Gynaecological Follow up Dermacyd Silver Floral (Lactic Acid).
- ClinicalTrials.gov ID
- NCT00933569
- Acronym / sponsor ID
- LACAC_L_04838
- Conditions
- Hygiene
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 7 Jul 2009 (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 safety of the gynaecological formulation in normal conditions of use.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dermacyd Silver Floral (Lactic Acid) | Experimental | Drug: LACTIC ACID(ND)Aplication of Dermacyd Silver Floral (Lactic Acid) during 21 consecutive days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Integral vaginal mucosa in the product analysis region
- Use the same category of cosmetics products
- Willingness in following the study procedures and to be present in the clinic at the days and scheduled time
Key exclusion criteria (9 listed)
- Use of Anti-inflammatory, immunossupression or antihistaminics drugs
- Allergic or atopic history to cosmetics products
- Cutaneous active disease (local and/or general) in the evaluated area
- Disease which can cause immunosuppresion, such as diabetes, HIV
- Endocrinology pathology such as thyroid gland, ovary and 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 |
|---|---|---|
| LACTIC ACID(ND)treatment period: 21 consecutive days | Drug | Dermacyd Silver Floral (Lactic Acid) |
Primary outcome
Evaluation of the absence of irritation and the good acceptability by using one specific scale which describes the intensity of the reaction.
Time frame: From the treatment start to the end of the study (treatment period 21 days)
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 14 Sep 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.
Jaderson Lima 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(ND) 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 3 inclusion and 9 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 14 Sep 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?
Evaluation of the absence of irritation and the good acceptability by using one specific scale which describes the intensity of the reaction. (time frame: From the treatment start to the end of the study (treatment period 21 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 14 Sep 2010.