Dermacyd Femina (Lactic Acid) - Photo Dermatological Evaluation of the Irritation and Sensitivity Potential.

NCT ID: NCT00705744

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

PHASE3

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Brief Summary

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To prove the absence of photo irritation and photo sensitivity potential of the product Dermacyd Femina.

Detailed Description

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Conditions

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Hygiene

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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I

Group Type EXPERIMENTAL

Lactic acid (Dermacyd Femina)

Intervention Type DRUG

Interventions

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Lactic acid (Dermacyd Femina)

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 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;
* 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

Principal Investigators

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Jaderson Lima, MD

Role: STUDY_DIRECTOR

Sanofi

Locations

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Sanofi-aventis

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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LACAC_L_03982

Identifier Type: -

Identifier Source: org_study_id

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