Dermacyd Infantile (Lactic Acid)- Compatibility.

Sanofi

Status and phase: Completed; Phase 4

Conditions: Hygiene

Treatments: Drug: LACTIC ACID(ND)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00881374

LACAC_L_04679

Details and patient eligibility

About

Primary Objective:

To demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergic potential (sensibilization) of the product Dermacyd Infantile.

Enrollment: 50 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Photo type 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 gestation
• Use of Anti-inflammatory 30 days and/or immunosuppressant drugs during 3 months before the selection
• Diseases which can cause immunity decrease, such as HIV, diabetes
• Previous atopy
• History of sensitivity or irritation for topic products
• Active cutaneous diseases which can interfere in the study results
• Use of new drugs and/ or cosmetics during the study
• Cutaneous reactivity
• Previous participation in studies, which had used the product
• Volunteers who have immunodeficiency congenital or acquired
• Relevant clinical history or present evidence of alcohol abuse or others drugs
• Non tolerance to some component of the study product.

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: Supportive Care

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Dermacyd Infantile (Lactic Acid)

Experimental group

Description:

six weeks treatment

Treatment:

Drug: LACTIC ACID(ND)