Dermacyd Delicata Pocket BR - Photo Evaluation

NCT ID: NCT00668226

Last Updated: 2009-01-29

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

PHASE3

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Brief Summary

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The purpose of this study is to prove the absence of photo irritation and photo sensitivity potential of the product Dermacyd Delicata Pocket BR.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Interventions

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Lactic acid (Dermacid)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Phototype Skin II and III
* Integral skin test in the region

Exclusion Criteria

* 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
* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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sanofi-aventis administrative office France

Principal Investigators

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Jaderson Lima

Role: STUDY_DIRECTOR

Sanofi-aventis administrative office Brazil

Locations

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Sanofi-aventis administrative office

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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LACAC_L_03745

Identifier Type: -

Identifier Source: org_study_id

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