HygienePhase 3NCT00933075
Dermacyd Silver Frutal (Lactic Acid) - Photo Evaluation.
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 demonstrate the absence of photoirritation and photosensitization potential of the product Dermacyd Silver Frutal. 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
- 27 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Phototype Skin II and III 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 pregnancy
- Use of Antiinflammatory 30 days and/or immunossupression drugs for until 3 months before volunteers selection
- Diseases which can cause immunosuppresion, such as diabetes, HIV
- Use of photosensitivity drugs
- History of sensitivity or photosensitivity for topic products
- Cutaneous active disease which can modify the study results
Show all 16Show fewer
- History or activity of photodermatosis
- Personal or family antecedents of cutaneous neoplasia photo induced
- Presence of injury precursor of cutaneous neoplasia, such as melanociticos nevus and actinic keratosis
- Intense exposure solar in the test region
- Use of new drugs and/or cosmetics during the study
- Previous participation in studies using the same product in test
- Relevant history or confirmation of alcohol or other drugs abuse
- Intolerance detected or suspected for some component of the sample tested
- Medecin or sponsor employees or their close family.
- 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: Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd Silver Frutal (Lactic Acid).
Primary Objective:
To demonstrate the absence of photoirritation and photosensitization potential of the product Dermacyd Silver Frutal.
- 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 Silver Frutal (Lactic Acid) sample will be applied like a curative for 5 weeks (treatment period).
| Study group | Role | What they receive |
|---|---|---|
| Dermacyd Silver Frutal (Lactic Acid) | Experimental | Dermacyd Silver Frutal (Lactic Acid) sample will be applied like a curative. Physiologic solution and mineral oil will be also usedas a control sample. Receives: Drug: LACTIC ACID(ND) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of the photo irritation test and the photosensitivity by using UVA irradiation and evaluation according to International Contact Dermatitis Research Group (ICDRG) scale. Evaluation of the sensibility according to the skin type.
Measured: From the treatment start to the end of the study (treatment period 5 weeks)
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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 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
- NCT00933075
- Sponsor's protocol ID
- LACAC_L_04843
- 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
- Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd Silver Frutal (Lactic Acid).
- ClinicalTrials.gov ID
- NCT00933075
- Acronym / sponsor ID
- LACAC_L_04843
- Conditions
- Hygiene
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 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 demonstrate the absence of photoirritation and photosensitization potential of the product Dermacyd Silver Frutal.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dermacyd Silver Frutal (Lactic Acid) | Experimental | Drug: LACTIC ACID(ND)Dermacyd Silver Frutal (Lactic Acid) sample will be applied like a curative. Physiologic solution and mineral oil will be also usedas a control sample. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Phototype Skin II and III 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 (16 listed)
- Lactation or pregnancy
- Use of Antiinflammatory 30 days and/or immunossupression drugs for until 3 months before volunteers selection
- Diseases which can cause immunosuppresion, such as diabetes, HIV
- Use of photosensitivity drugs
- History of sensitivity or photosensitivity 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 Silver Frutal (Lactic Acid) sample will be applied like a curative for 5 weeks (treatment period). | Drug | Dermacyd Silver Frutal (Lactic Acid) |
Primary outcome
Measure of the photo irritation test and the photosensitivity by using UVA irradiation and evaluation according to International Contact Dermatitis Research Group (ICDRG) scale. Evaluation of the sensibility according to the skin type.
Time frame: From the treatment start to the end of the study (treatment period 5 weeks)
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 2 inclusion and 16 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?
Measure of the photo irritation test and the photosensitivity by using UVA irradiation and evaluation according to International Contact Dermatitis Research Group (ICDRG) scale. Evaluation of the sensibility according to the skin type. (time frame: From the treatment start to the end of the study (treatment period 5 weeks)). 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.