Dermacyd Infantile (Lactic Acid) - Photo Evaluation.

NCT ID: NCT00881348

Last Updated: 2009-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2009-03-31

Brief Summary

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Primary Objective:

To demonstrate the absence of photo irritation and photosensitization potential of the product Dermacyd Infantile (Lactic Acid).

Detailed Description

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Conditions

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Hygiene

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Dermacyd infantile (Lactic Acid)

5 weeks treatment

Group Type EXPERIMENTAL

LACTIC ACID(ND)

Intervention Type DRUG

Dermacyd infantile (Lactic Acid)

Interventions

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LACTIC ACID(ND)

Dermacyd infantile (Lactic Acid)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Phototype Skin I, II, III and 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.

Exclusion Criteria

* Use of Anti-inflammatory, immunosuppressant or anti-histaminic drugs
* Lactation or gestation
* Use of Anti-inflammatory drugs 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
* 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.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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sanofi-aventis

Principal Investigators

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Jaderson Lima

Role: STUDY_DIRECTOR

Sanofi

Locations

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Sanofi-Aventis Administrative Office

São Paulo, , Brazil

Site Status

Countries

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Brazil

Other Identifiers

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LACAC_L_04680

Identifier Type: -

Identifier Source: org_study_id

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