Dermatological Evaluation of Topic Compatibility - Dermacyd Breeze

The purpose of this study is to demonstrate the absence of irritation potential (primary dermal irritability and cumulated dermal irritability) and allergy (sensibilization) of the product Dermacyd Pocket BR.

Completed

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Key information

Conditions

Healthy

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

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

Phototype Skin I,II, III e IV
Integral skin test in the region

Exclusion criteria

Use of Antiinflammatory and/or immunosuppression drugs
Personnel history of atopy
History of sensitivity or irritation for topic products
Active cutaneous disease
Use of new drugs or cosmetics during the study

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 (Dermacid)

Drug

Primary outcomes

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

Time frame: six weeks

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

Study for Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermical Irritability, Dermical Sensitivity) of Dermacyd Breeze.

Important dates

Study start: 2007
Primary completion: 2008
First posted: Apr 29, 2008
Registry last updated: Feb 10, 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