Dermacyd Infantile - Acceptability.

Sanofi

Status and phase: Completed; Phase 4

Conditions: Hygiene

Treatments: Drug: LACTIC ACID(ND)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00881270

LACAC_L_04678

Details and patient eligibility

About

Primary Objective:

To prove the safety of the formulation in normal conditions of use.

Enrollment: 31 patients

Sex: All

Ages: Under 12 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Integral skin test in the region
• Use the same category of cosmetics
• Willingness in following the study procedures and to be present in the clinic at the days and scheduled time.

Exclusion criteria

• Use of Anti-inflammatory, immunosuppressant or anti-histaminic drugs
• Allergic or atopic history to cosmetics products
• Cutaneous active disease (local or general) in the evaluated area
• Disease which can cause immunosuppressant, such as diabetes, HIV
• Endocrine pathology
• Intensive solar exposure until 15 days before evaluation
• Treatment four months before selection.

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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31 participants in 1 patient group

Dermacyd infantile (Lactic Acid)

Experimental group

Description:

treatment duration 21 consecutive days

Treatment:

Drug: LACTIC ACID(ND)