Dermacyd PH_DETINLYN (Lactic Acid) Sweet Flower - Photo Evaluation. - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00785590

Purpose

To demonstrate the absence of photoirritation and photosensitization potential of the product Dermacyd PHDETINLYN Sweet Flower.

Condition	Intervention	Phase
Hygiene	Drug: Dermacyd PH_DETINLYN (Lactic Acid)	Phase III

Drug Information available for: Lactic acid Ammonium lactate

Study Type:	Interventional
Study Design:	Supportive Care, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd PH_DETINLYN (Lactic Acid) Sweet Flower.

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: Throughout the study ] [ Designated as safety issue: No ]
The sensibility will be evaluated according to the skin type. [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]

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

Arms	Assigned Interventions
1: Experimental Dermacyd PH_DETINLYN (Lactic Acid)	Drug: Dermacyd PH_DETINLYN (Lactic Acid)

Eligibility

Criteria

Inclusion criteria:

Phototype Skin II and III;
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 Antiinflammatory and/or immunosuppression 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 of photodermatosis active;
Family or personal antecedent of cutaneous photoinduced neoplasias;
Presence of a precursor lesion of cutaneous neoplasia, such as nevus melanocyte and queratoses 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: NCT00785590

Locations

Brazil
Sanofi-Aventis Administrative Office
Sao Paulo, Brazil

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Jaderson Lima

Sanofi-Aventis

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:	LACAC_L_04300
Study First Received:	November 4, 2008
Last Updated:	November 4, 2008
ClinicalTrials.gov Identifier:	NCT00785590
Health Authority:	Brazil: National Health Surveillance Agency

ClinicalTrials.gov processed this record on January 16, 2009