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

This study has been completed.

Sponsor:

Information provided by:

Sanofi

ClinicalTrials.gov Identifier:

NCT00785590

First received: November 4, 2008

Last updated: August 21, 2009

Last verified: August 2009

History of Changes

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 3


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care
Official Title:	Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd PH_DETINLYN (Lactic Acid) Sweet Flower.

Resource links provided by NLM:

Drug Information available for: Lactic acid Ammonium lactate

U.S. FDA Resources

Further study details as provided by Sanofi:

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

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

Eligibility


Ages Eligible for Study:	18 Years to 60 Years (Adult)
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00785590

Locations


Brazil
Sanofi-Aventis Administrative Office
Sao Paulo, Brazil

Sponsors and Collaborators

Sanofi

Investigators


Study Director:	Jaderson Lima	Sanofi

More Information


Responsible Party:	Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier:	NCT00785590 History of Changes
Other Study ID Numbers:	LACAC_L_04300
Study First Received:	November 4, 2008
Last Updated:	August 21, 2009
Health Authority:	Brazil: National Health Surveillance Agency

ClinicalTrials.gov processed this record on September 23, 2016

To Top