HygienePhase 4NCT00881374
Dermacyd Infantile (Lactic Acid)- Compatibility.
A Phase 4 study testing LACTIC ACID(ND) in people with Hygiene, run by Sanofi at 1 site in Brazil.
Trial summary
Primary Objective: To demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergic potential (sensibilization) of the product Dermacyd Infantile. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy 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
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2009to Mar 2009
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Photo type Skin I,II, III e IV
- Integral skin test in the region
- Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion.
Who cannot join
- Lactation or gestation
- Use of Anti-inflammatory 30 days and/or immunosuppressant drugs during 3 months before the selection
- Diseases which can cause immunity decrease, such as HIV, diabetes
- Previous atopy
- History of sensitivity or irritation for topic products
- Active cutaneous diseases which can interfere in the study results
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- Use of new drugs and/ or cosmetics during the study
- Cutaneous reactivity
- Previous participation in studies, which had used the product
- Volunteers who have immunodeficiency congenital or acquired
- Relevant clinical history or present evidence of alcohol abuse or others drugs
- Non tolerance to some component of the study product.
- 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: Study for Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermic Irritability, Dermic Sensitivity) of Dermacyd Infantile (Lactic Acid).
Primary Objective:
To demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergic potential (sensibilization) of the product Dermacyd Infantile.
- 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
Dermacyd Infantile (Lactic Acid)
| Study group | Role | What they receive |
|---|---|---|
| Dermacyd Infantile (Lactic Acid) | Experimental | six weeks treatment Receives: Drug: LACTIC ACID(ND) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The absence of primary and accumulated dermic irritability and dermic sensitivity will be evaluated using International Contact Dermatitis Research Group (ICDRG) scale.
Measured: During 6 weeks (i.e. treatment period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2009 (estimated)
- Study startFeb 2009
- Primary completionMar 2009
- Study completionMar 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 4
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 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
- NCT00881374
- Sponsor's protocol ID
- LACAC_L_04679
- Status last verified
- Apr 2009
- First submitted
- 10 Apr 2009
- Last updated
- 15 Apr 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study for Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermic Irritability, Dermic Sensitivity) of Dermacyd Infantile (Lactic Acid).
- ClinicalTrials.gov ID
- NCT00881374
- Acronym / sponsor ID
- LACAC_L_04679
- Conditions
- Hygiene
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 15 Apr 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 demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergic potential (sensibilization) of the product Dermacyd Infantile.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dermacyd Infantile (Lactic Acid) | Experimental | Drug: LACTIC ACID(ND)six weeks treatment |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Photo type Skin I,II, III e IV
- Integral skin test in the region
- Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion.
Key exclusion criteria (13 listed)
- Lactation or gestation
- Use of Anti-inflammatory 30 days and/or immunosuppressant drugs during 3 months before the selection
- Diseases which can cause immunity decrease, such as HIV, diabetes
- Previous atopy
- History of sensitivity or irritation for topic products
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)Dermacyd Infantile (Lactic Acid) | Drug | Dermacyd Infantile (Lactic Acid) |
Primary outcome
The absence of primary and accumulated dermic irritability and dermic sensitivity will be evaluated using International Contact Dermatitis Research Group (ICDRG) scale.
Time frame: During 6 weeks (i.e. treatment period)
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 15 Apr 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 4 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 13 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 15 Apr 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 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?
The absence of primary and accumulated dermic irritability and dermic sensitivity will be evaluated using International Contact Dermatitis Research Group (ICDRG) scale. (time frame: During 6 weeks (i.e. treatment period)). 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 15 Apr 2009.