HygienePhase 4LACTAFEMNCT00712868
Acceptability of Lactacyd Femina
A Phase 4 study testing Lactic acid in people with Hygiene, run by Sanofi at 1 site in Mexico.
Trial summary
To demonstrate the safety and acceptability of the gynaecological formulation. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hygiene
- What is being tested?
- Lactic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 559 participants
- Where
- 1 siteMexico
- Study dates
- Jun 2008to Aug 2008
- Phase
- Phase 4
- 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 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Integral skin in the tested region
Who cannot join
- Pregnancy or breastfeeding women
- Use of anti-inflammatory or immune-suppression drugs
- Topical medication use at the tested region
- Active cutaneous gynaecological disease which may interfere in study results
- Personal history of allergic disease at the area to be treated
- Allergic or atopic history
- 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: Safety Dermatological Evaluation: Acceptability With Gynaecological Follow up Lactacyd Femina
To demonstrate the safety and acceptability of the gynaecological formulation.
- Conditions
- Hygiene
- Being tested
- Lactic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactic acidDrug
Once a day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Lactic Acid once a day during 21 days Receives: Drug: Lactic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical and local tolerability
Measured: After 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2008 (estimated)
- Study startJun 2008
- Primary completionAug 2008
- Study completionAug 2008
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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 559 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Judith Diaz, Md, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00712868
- Sponsor's protocol ID
- LACAC_L_03447
- Acronym
- LACTAFEM
- Status last verified
- Jul 2009
- First submitted
- 7 Jul 2008
- Last updated
- 20 Jul 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Dermatological Evaluation: Acceptability With Gynaecological Follow up Lactacyd Femina
- ClinicalTrials.gov ID
- NCT00712868
- Acronym / sponsor ID
- LACTAFEM / LACAC_L_03447
- Conditions
- Hygiene
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 559 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 10 Jul 2008 (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.
To demonstrate the safety and acceptability of the gynaecological formulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Lactic acidLactic Acid once a day during 21 days |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Integral skin in the tested region
Key exclusion criteria (7 listed)
- Pregnancy or breastfeeding women
- Use of anti-inflammatory or immune-suppression drugs
- Topical medication use at the tested region
- Active cutaneous gynaecological disease which may interfere in study results
- Personal history of allergic disease at the area to be treated
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 acidOnce a day | Drug | 1 |
Primary outcome
Clinical and local tolerability
Time frame: After 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 20 Jul 2009.
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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.
Judith Diaz, Md 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 4 study testing Lactic acid in people with Hygiene, run by Sanofi at 1 site in Mexico.
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 1 inclusion and 7 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 20 Jul 2009. 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 Mexico. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Clinical and local tolerability (time frame: After 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 20 Jul 2009.