HygienePhase 3NCT00784069

Dermacyd Breeze (Lactic Acid) Pocket BR - Photo Evaluation

A Phase 3 study testing Lactic Acid in people with Hygiene, run by Sanofi at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

To demonstrate the absence of photoirritation and photosensitization potential of the product Dermacyd Breeze (Lactic Acid) Pocket BR. 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
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 27 participants
Where: 1 siteBrazil
Study dates: Oct 2008to Nov 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

Age between 18 and 60 years old;
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 gestation;
Use of Antiinflammatory and/or immunosuppression 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;

Show all 12Show fewer

History of photodermatosis active;
Family or personal antecedent of cutaneous photoinduced neoplasias;
Presence of a precursor lesion of cutaneous neoplasia, such as nevus melanocyte and queratoses 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.

Brazil1 site

Sanofi-Aventis Administrative Office
São Paulo

Other trials in Brazil

About this study

Official title: Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd Breeze Pocket BR.

To demonstrate the absence of photoirritation and photosensitization potential of the product Dermacyd Breeze (Lactic Acid) Pocket BR.

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 Breeze)

Study groups in NCT00784069
Study group	Role	What they receive
1	Experimental	Lactic Acid (Dermacyd Breeze) Receives: Drug: Lactic Acid

What is being measured

The primary outcome is the main question the study is designed to answer.

To demonstrate the absence of photoirritation and photosensitization potential of the product Dermacyd Breeze Pocket BR.
Measured: Throughout the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2008Nov 2008

First posted3 Nov 2008 (estimated)
Study startOct 2008
Primary completionNov 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: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00784069
Sponsor's protocol ID: LACAC_L_04367
Status last verified: Dec 2008
First submitted: 31 Oct 2008
Last updated: 19 Dec 2008
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hygiene trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Dec 2008. 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 Breeze Pocket BR.
ClinicalTrials.gov ID: NCT00784069
Acronym / sponsor ID: LACAC_L_04367
Conditions: Hygiene
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: SanofiIndustry (pharma, biotech, devices)
Study start: Oct 2008
Primary completion: Nov 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.

To demonstrate the absence of photoirritation and photosensitization potential of the product Dermacyd Breeze (Lactic Acid) Pocket BR.

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 Breeze)

Who may qualify

Ages: 18 to 60 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Age between 18 and 60 years old;
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 (12 listed)

Lactation or gestation;
Use of Antiinflammatory and/or immunosuppression 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 AcidLactic Acid (Dermacyd Breeze)	Drug	1

Primary outcome

To demonstrate the absence of photoirritation and photosensitization potential of the product Dermacyd Breeze Pocket BR.
Time frame: Throughout 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 19 Dec 2008.
Related InfoLink provided by the sponsor.

Related trials for Hygiene

Enrolling by invitation
Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial Outcomes and Oral Tolerance in People With Gingivitis
Microbiome, Cytokines
Not yet recruiting
Game-based Oral Health Promotion
Oral Hygiene
Not yet recruiting
Effectiveness of Personalized Digital Oral Health Intervention in Patients With Fixed Orthodontic Appliances.
Oral Hygiene in Patients With Fixed Orthodontic Appliances, Dental Plaque
Not yet recruitingPhase 3
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Preterm Birth, Low Birth Weight
Recruiting
Climate-Responsive Nutrition, WASH, and Heat Counselling for Maternal and Child Health in Sindh, Pakistan
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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 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 19 Dec 2008. 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?

To demonstrate the absence of photoirritation and photosensitization potential of the product Dermacyd Breeze Pocket BR. (time frame: Throughout the study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00784069.

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 19 Dec 2008.