Dermacyd Silver Floral (Lactic Acid) - Compatibility.

Sanofi

Status and phase: Completed; Phase 3

Conditions: Hygiene

Treatments: Drug: LACTIC ACID(ND)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00933712

LACAC_L_04839

Details and patient eligibility

About

Primary Objective:

To demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product Dermacyd Silver Floral

Enrollment: 55 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Phototype Skin I,II, III e 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

• Lactation or pregnancy
• Use of Antiinflammatory 30 days and/or immunossupression drugs for until 3 months before volunteers selection
• Disease which can cause immunosuppresion, such as diabetes, HIV
• Use of Antihistamines 30 days before selection
• Personnel history of atopy
• History of sensitivity or irritation for topic products
• Cutaneous active disease (local and/or general) which can modify the study results
• Use of new drugs and/or cosmetics during the study
• Cutaneous reaction
• Previous participation in studies using the same product in test
• Volunteer which has immunodeficiency congenital or acquired
• 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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55 participants in 1 patient group

Dermacyd Silver Floral (Lactic Acid)

Experimental group

Description:

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

Treatment:

Drug: LACTIC ACID(ND)