HygienePhase 3NCT00664391
Safety Dermatological Evaluation: Acceptability With Gynecological Follow up - Dermacyd Breeze
A Phase 3 study testing Lactic acid (Dermacid) in people with Hygiene, run by Sanofi at 1 site in Brazil.
Trial summary
The purpose of this study is to demonstrate the safety of the gynecological formulation in normal and usual usage condition of Dermacyd Breeze. 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 (Dermacid)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2008to Feb 2008
- 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 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Integral skin test in the region;
Who cannot join
- Lactation or gestational risk or gestation;
- Use of Anti-inflammatory or immunosuppression drugs 1 month before the study;
- Topical medication use at the region to be treated;
- Cutaneous disease or active gynecological 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: Monocentric Study, Phase III, for Safety Dermatological Evaluation: Acceptability With Gynecological Follow up - Dermacyd Breeze
The purpose of this study is to demonstrate the safety of the gynecological formulation in normal and usual usage condition of Dermacyd Breeze.
- Conditions
- Hygiene
- Being tested
- Lactic acid (Dermacid)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactic acid (Dermacid)Drug
Liquid soup to be applied in the external genital area, in small quantity, with abundantly rinse after use, during 21 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Lactic acid (Dermacid) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events and their intensity and their association with the treatment.
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2008 (estimated)
- Study startJan 2008
- Primary completionFeb 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 3
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jaderson Lima, Study director, Sanofi-aventis administrative office Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00664391
- Sponsor's protocol ID
- LACAC_L_03746
- Status last verified
- Feb 2009
- First submitted
- 18 Apr 2008
- Last updated
- 10 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2009. 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 Gynecological Follow up - Dermacyd Breeze
- ClinicalTrials.gov ID
- NCT00664391
- Acronym / sponsor ID
- LACAC_L_03746
- Conditions
- Hygiene
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Feb 2008 (actual)
- First posted
- 22 Apr 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.
The purpose of this study is to demonstrate the safety of the gynecological formulation in normal and usual usage condition of Dermacyd Breeze.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Lactic acid (Dermacid) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Integral skin test in the region;
Key exclusion criteria (7 listed)
- Lactation or gestational risk or gestation;
- Use of Anti-inflammatory or immunosuppression drugs 1 month before the study;
- Topical medication use at the region to be treated;
- Cutaneous disease or active gynecological 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 acid (Dermacid)Liquid soup to be applied in the external genital area, in small quantity, with abundantly rinse after use, during 21 days | Drug | 1 |
Primary outcome
Adverse events and their intensity and their association with the treatment.
Time frame: 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 10 Feb 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.
Jaderson Lima study director
Sanofi-aventis administrative office Brazil
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) 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 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 10 Feb 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 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?
Adverse events and their intensity and their association with the treatment. (time frame: 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 10 Feb 2009.