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Dermacyd Silver Frutal (Lactic Acid) - Photo Evaluation.

NCT ID: NCT00933075

Last Updated: 2010-09-14

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

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2009-07-31

Brief Summary

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Primary Objective:

To demonstrate the absence of photoirritation and photosensitization potential of the product Dermacyd Silver Frutal.

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

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dermacyd Silver Frutal (Lactic Acid)

Dermacyd Silver Frutal (Lactic Acid) sample will be applied like a curative. Physiologic solution and mineral oil will be also usedas a control sample.

Group Type EXPERIMENTAL

LACTIC ACID(ND)

Intervention Type DRUG

Dermacyd Silver Frutal (Lactic Acid) sample will be applied like a curative for 5 weeks (treatment period).

Interventions

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LACTIC ACID(ND)

Dermacyd Silver Frutal (Lactic Acid) sample will be applied like a curative for 5 weeks (treatment period).

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Lactation or pregnancy
* Use of Antiinflammatory 30 days and/or immunossupression drugs for until 3 months before volunteers selection
* Diseases which can cause immunosuppresion, such as diabetes, HIV
* Use of photosensitivity drugs
* History of sensitivity or photosensitivity for topic products
* Cutaneous active disease which can modify the study results
* History or activity of photodermatosis
* Personal or family antecedents of cutaneous neoplasia photo induced
* Presence of injury precursor of cutaneous neoplasia, such as melanociticos nevus and actinic keratosis
* Intense exposure solar in the test region
* Use of new drugs and/or cosmetics during the study
* Previous participation in studies using the same product in test
* Relevant history or confirmation of alcohol or other drugs abuse
* Intolerance detected or suspected for some component of the sample tested
* Medecin or sponsor employees or their close family.

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_04843

Identifier Type: -

Identifier Source: org_study_id