Dermacyd Infantile (Lactic Acid) - Photo Evaluation.

Sanofi

Status and phase: Completed; Phase 4

Conditions: Hygiene

Treatments: Drug: LACTIC ACID(ND)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00881348

LACAC_L_04680

Details and patient eligibility

About

Primary Objective:

To demonstrate the absence of photo irritation and photosensitization potential of the product Dermacyd Infantile (Lactic Acid).

Enrollment: 25 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Phototype Skin I, II, III and 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

• Use of Anti-inflammatory, immunosuppressant or anti-histaminic drugs
• Lactation or gestation
• Use of Anti-inflammatory drugs 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.

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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25 participants in 1 patient group

Dermacyd infantile (Lactic Acid)

Experimental group

Description:

5 weeks treatment

Treatment:

Drug: LACTIC ACID(ND)