HygienePhase 2NCT00679562
Lactacyd Radiance (Lactic Acid) Prophetic Patch Test
A Phase 2 study testing Lactic Acid and Distilled water in people with Hygiene, run by Sanofi at 1 site in Thailand.
Trial summary
Primay objective: To evaluate the potential of the products in eliciting adverse skin reaction. 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 and Distilled water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteThailand
- Study dates
- Mar 2008to Apr 2008
- Phase
- Phase 2
- 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
- Test area should have a healthy or normal skin
- Individuals free of any systemic or dermatological disorder which, in the opinion of the investigative personnel would interfere with the study results or increase the risk of adverse reaction
- Not currently use of steroid or any medication during the test
Who cannot join
- History of Allergy or Allergic Reaction to:
- Hey Fever
- Asthma
- Poison Ivy
- Food
- Cosmetics
Show all 14Show fewer
- Soap
- Detergent
- Metal
- Jewelry
- Lather
- Fabric
- Medication
- 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: Skin Irritation : Prophetic Patch Test of Lactacyd Radiance
Primay objective:
To evaluate the potential of the products in eliciting adverse skin reaction.
- Conditions
- Hygiene
- Being tested
- Lactic Acid, Distilled water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactic AcidDrug
Also called Lactacyd Radiance
Application of occlusive patches containing test product. For 24 hours and repeat 2 weeks later for participants with no reaction to Lactacyd Radiance
Distilled waterOther
Application of patches containing distilled water for 24 hours
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Lactic Acid |
| 2 | Placebo comparator | Not described Receives: Other: Distilled water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reaction after patch removal.
Measured: at 15-30 minutes and day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2008 (estimated)
- Study startMar 2008
- Primary completionApr 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 2
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Taweeporn NATESUMROENG, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00679562
- Sponsor's protocol ID
- LACAC_L_03648
- Status last verified
- Feb 2009
- First submitted
- 15 May 2008
- Last updated
- 6 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin Irritation : Prophetic Patch Test of Lactacyd Radiance
- ClinicalTrials.gov ID
- NCT00679562
- Acronym / sponsor ID
- LACAC_L_03648
- Conditions
- Hygiene
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Apr 2008 (actual)
- First posted
- 19 May 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.
Primay objective:
To evaluate the potential of the products in eliciting adverse skin reaction.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Lactic Acid |
| 2 | Placebo comparator | Other: Distilled water |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Test area should have a healthy or normal skin
- Individuals free of any systemic or dermatological disorder which, in the opinion of the investigative personnel would interfere with the study results or increase the risk of adverse reaction
- Not currently use of steroid or any medication during the test
Key exclusion criteria (14 listed)
- History of Allergy or Allergic Reaction to:
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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 AcidAlso: Lactacyd RadianceApplication of occlusive patches containing test product. For 24 hours and repeat 2 weeks later for participants with no reaction to Lactacyd Radiance | Drug | 1 |
| Distilled waterApplication of patches containing distilled water for 24 hours | Other | 2 |
Primary outcome
Reaction after patch removal.
Time frame: at 15-30 minutes and day 3
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 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.
Taweeporn NATESUMROENG 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 2 study testing Lactic Acid and Distilled water in people with Hygiene, run by Sanofi at 1 site in Thailand.
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 14 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 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 Thailand. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Reaction after patch removal. (time frame: at 15-30 minutes and day 3). 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 Feb 2009.