Dermacyd Femina Delicata (Lactic Acid)- Photo Dermatological Evaluation of the Irritation and Sensitivity Potential

This study has been completed.

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00705276

Purpose

To prove the absence of photo irritation and photo sensitivity potential of the product Dermacyd Femina Delicata.

Condition	Intervention	Phase
Hygiene	Drug: Lactic acid (Dermacyd Femina Delicata)	Phase III

Drug Information available for: Lactic acid Ammonium lactate

Study Type:	Interventional
Study Design:	Supportive Care, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd Femina Delicata

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

The photo irritation test and the photosensitivity will be measured using UVA irradiation and evaluated according International Contact Dermatitis Research Group (ICDRG) scale. [ Time Frame: 5 weeks ] [ Designated as safety issue: Yes ]
The sensibility will be evaluated according the skin type. [ Time Frame: 5 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	26
Study Start Date:	April 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
I: Experimental	Drug: Lactic acid (Dermacyd Femina Delicata)

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Lactation or gestation;
Use of Anti-inflammatory and/or immuno-suppression drugs 15 days before the selection;
Diseases which can cause immunity decrease, such as HIV, diabetes;
Use of drug photosensitizer;
History of sensitivity or irritation for topic products;
Active cutaneous disease which can change the study results;
History or photodermatosis active;
Family or personal antecedent of cutaneous photoinduced neoplasias;
Presence of a precursor lesion of cutaneous neoplasia, such as nevus melanocyte and keratoses actinium;
Intense solar exposure in the study area;
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00705276

Locations

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Jaderson Lima, MD

Sanofi-Aventis

More Information

Responsible Party:	sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:	LACAC_L_03983
Study First Received:	June 25, 2008
Last Updated:	June 25, 2008
ClinicalTrials.gov Identifier:	NCT00705276
Health Authority:	Brazil: National Health Surveillance Agency

ClinicalTrials.gov processed this record on January 16, 2009