HygienePhase 3NCT00783939
Dermacyd PH_DETINBACK Tangerine Mix (Lactic Acid) - Safety.
A Phase 3 study testing Lactic Acid in people with Hygiene, run by Sanofi at 1 site in Brazil.
Trial summary
The purpose of this study is to prove the safety in normal conditions of useof the product Dermacyd PH_DETINBACK Tangerine Mix (Lactic Acid). Read more about this study
- Who is it for?
- Ages 10 to 20 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
- 31 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2008to Sep 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 10 to 20 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age between 10 and 20 years old;
- Integral skin test in the region;
- Use of cosmetic product of the same category;
- Willingness in following the study procedures and to be present in the clinic at the days and scheduled time;
Who cannot join
- Lactation or gestational risk or gestation;
- Use of Anti-inflammatory, immunosuppression or antihistaminic drugs;
- Atopic antecedent or allergic to cosmetic product;
- Active cutaneous disease in the evaluation area;
- Diseases which cause immunology decrease, such as diabetes and HIV;
- Endocrinal pathologies;
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- Intense solar exposure 15 days before the evaluation;
- Treatment until four months before the selection;
- 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: Vaginal Mucous Irritation - Product Tested: Dermacyd PH_DETINBACK Tangerine Mix (Lactic Acid).
The purpose of this study is to prove the safety in normal conditions of useof the product Dermacyd PH_DETINBACK Tangerine Mix (Lactic Acid).
- 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
Lactic Acid (Dermacyd PH_DETINBACK Tangerine Mix)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Lactic Acid (Dermacyd PH_DETINBACK Tangerine Mix) Receives: Drug: Lactic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
The absence of irritation and the good acceptability will be evaluated using one specific scale which describes the intensity of the reaction.
Measured: From the treatment start to the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2008 (estimated)
- Study startSep 2008
- Primary completionSep 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
- 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
- NCT00783939
- Sponsor's protocol ID
- LACAC_L_04307
- Status last verified
- Mar 2009
- First submitted
- 31 Oct 2008
- Last updated
- 6 Mar 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Dermatological Evaluation: Vaginal Mucous Irritation - Product Tested: Dermacyd PH_DETINBACK Tangerine Mix (Lactic Acid).
- ClinicalTrials.gov ID
- NCT00783939
- Acronym / sponsor ID
- LACAC_L_04307
- Conditions
- Hygiene
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Sep 2008 (actual)
- First posted
- 3 Nov 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 prove the safety in normal conditions of useof the product Dermacyd PH_DETINBACK Tangerine Mix (Lactic Acid).
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 AcidLactic Acid (Dermacyd PH_DETINBACK Tangerine Mix) |
Who may qualify
- Ages
- 10 to 20 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age between 10 and 20 years old;
- Integral skin test in the region;
- Use of cosmetic product of the same category;
- Willingness in following the study procedures and to be present in the clinic at the days and scheduled time;
Key exclusion criteria (9 listed)
- Lactation or gestational risk or gestation;
- Use of Anti-inflammatory, immunosuppression or antihistaminic drugs;
- Atopic antecedent or allergic to cosmetic product;
- Active cutaneous disease in the evaluation area;
- Diseases which cause immunology decrease, such as diabetes and HIV;
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 AcidLactic Acid (Dermacyd PH_DETINBACK Tangerine Mix) | Drug | 1 |
Primary outcome
The absence of irritation and the good acceptability will be evaluated using one specific scale which describes the intensity of the reaction.
Time frame: From the treatment start to the end of the study
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 6 Mar 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
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 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 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 6 Mar 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?
The absence of irritation and the good acceptability will be evaluated using one specific scale which describes the intensity of the reaction. (time frame: From the treatment start to the end of the study). 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 6 Mar 2009.