Dermacyd Silver Frutal (Lactic Acid) - Photo Evaluation.

Study Overview
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Brief Summary
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Primary Objective: To demonstrate the absence of photoirritation and photosensitization potential of the product Dermacyd Silver Frutal.

Official Title
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Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd Silver Frutal (Lactic Acid).

Conditions
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Hygiene

Intervention / Treatment
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* Drug: LACTIC ACID(ND)


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dermacyd Silver Frutal (Lactic Acid)<br>Dermacyd Silver Frutal (Lactic Acid) sample will be applied like a curative. Physiologic solution and mineral oil will be also usedas a control sample. | Drug: LACTIC ACID(ND)<br>* Dermacyd Silver Frutal (Lactic Acid) sample will be applied like a curative for 5 weeks (treatment period).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of the photo irritation test and the photosensitivity by using UVA irradiation and evaluation according to International Contact Dermatitis Research Group (ICDRG) scale. Evaluation of the sensibility according to the skin type. |  | From the treatment start to the end of the study (treatment period 5 weeks) |