Dermacyd Delicata Breeze - Photo Evaluation

This study has been completed.

Sponsor:

Information provided by:

Sanofi-Aventis

ClinicalTrials.gov Identifier:

NCT00668486

First received: April 23, 2008

Last updated: February 9, 2009

Last verified: February 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

April 23, 2008

Last Updated Date

February 9, 2009

Start Date ^ICMJE

January 2008

Primary Completion Date

February 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00668486 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Dermacyd Delicata Breeze - Photo Evaluation

Official Title ^ICMJE

Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd Breeze.

Brief Summary

The purpose of this study is to prove the absence of photo irritation and photo sensitivity potential of the product Dermacyd Breeze.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Drug: Lactic acid (Dermacid)

Study Arm (s)

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

February 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Phototype Skin II and III
Integral skin test in the region

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 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.

Gender

Female

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Brazil

Administrative Information

NCT Number ^ICMJE

NCT00668486

Other Study ID Numbers ^ICMJE

LACAC_L_03748

Has Data Monitoring Committee

Responsible Party

GMA-CO/Medical Director, sanofi-aventis administrative office France

Study Sponsor ^ICMJE

Sanofi-Aventis

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Jaderson Lima

Sanofi-aventis administrative office Brazil

Information Provided By

Sanofi-Aventis

Verification Date

February 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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