HygienePhase 3NCT00705744
Dermacyd Femina (Lactic Acid) - Photo Dermatological Evaluation of the Irritation and Sensitivity Potential.
A Phase 3 study testing Lactic acid (Dermacyd Femina) in people with Hygiene, run by Sanofi at 1 site in Brazil.
Trial summary
To prove the absence of photo irritation and photo sensitivity potential of the product Dermacyd Femina. 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 (Dermacyd Femina)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2008to May 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
- Phototype Skin II and III;
- Integral skin test in the region;
Who cannot join
- Lactation or gestation;
- Use of Anti-inflammatory and/or immuno-suppression drugs 15 days before the selection;
- Diseases which can cause immunity decrease, such as HIV, diabetes;
- Use of drug photosensitizer;
- History of sensitivity or irritation for topic products;
- Active cutaneous disease which can change the study results;
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- History or photodermatosis active;
- Family or personal antecedent of cutaneous photoinduced neoplasias;
- Presence of a precursor lesion of cutaneous neoplasia, such as nevus melanocyte and keratoses actinium;
- Intense solar exposure in the study area;
- Use of new drugs or cosmetics during the study;
- 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 Femina.
To prove the absence of photo irritation and photo sensitivity potential of the product Dermacyd Femina.
- Conditions
- Hygiene
- Being tested
- Lactic acid (Dermacyd Femina)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactic acid (Dermacyd Femina)Drug
| Study group | Role | What they receive |
|---|---|---|
| I | Experimental | Not described Receives: Drug: Lactic acid (Dermacyd Femina) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The photo irritation test and the photosensitivity will be measured using UVA irradiation and evaluated according International Contact Dermatitis Research Group (ICDRG) scale
Measured: 5 weeks
The sensibility will be evaluated according to the skin type.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2008 (estimated)
- Study startApr 2008
- Primary completionMay 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jaderson Lima, MD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00705744
- Sponsor's protocol ID
- LACAC_L_03982
- Status last verified
- Apr 2009
- First submitted
- 25 Jun 2008
- Last updated
- 15 Apr 2009
- Results posted
- No
- Data monitoring committee
- 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
- Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd Femina.
- ClinicalTrials.gov ID
- NCT00705744
- Acronym / sponsor ID
- LACAC_L_03982
- Conditions
- Hygiene
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- May 2008 (actual)
- First posted
- 26 Jun 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 prove the absence of photo irritation and photo sensitivity potential of the product Dermacyd Femina.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| I | Experimental | Drug: Lactic acid (Dermacyd Femina) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Phototype Skin II and III;
- Integral skin test in the region;
Key exclusion criteria (12 listed)
- Lactation or gestation;
- Use of Anti-inflammatory and/or immuno-suppression drugs 15 days before the selection;
- Diseases which can cause immunity decrease, such as HIV, diabetes;
- Use of drug photosensitizer;
- 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 (Dermacyd Femina) | Drug | I |
Primary outcome
The photo irritation test and the photosensitivity will be measured using UVA irradiation and evaluated according International Contact Dermatitis Research Group (ICDRG) scale
Time frame: 5 weeks
The sensibility will be evaluated according to the skin type.
Time frame: 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 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, 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 3 study testing Lactic acid (Dermacyd Femina) 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 12 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 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 photo irritation test and the photosensitivity will be measured using UVA irradiation and evaluated according International Contact Dermatitis Research Group (ICDRG) scale (time frame: 5 weeks). The study lists 2 primary outcomes in all. 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.