Dermacyd Infantile (Lactic Acid)- Compatibility.

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.

Completed

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Key information

Conditions

Hygiene

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sanofi-Aventis Administrative Office

São Paulo, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LACTIC ACID(ND)

Drug

Dermacyd Infantile (Lactic Acid)

Primary outcomes

The absence of primary and accumulated dermic irritability and dermic sensitivity will be evaluated using International Contact Dermatitis Research Group (ICDRG) scale.

Time frame: During 6 weeks (i.e. treatment period)

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

Study for Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermic Irritability, Dermic Sensitivity) of Dermacyd Infantile (Lactic Acid).

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2009
First posted: Apr 15, 2009
Registry last updated: Apr 15, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed