Dermacyd PH_DESILSTY_FL (Lactic Acid) - Photo Evaluation - Stay on Floral - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00933842

Purpose

Primary Objective:

To demonstrate the absence of photoirritation and photosensitization potential of the product Dermacyd PHDESILSTYFL.

Secondary Objective:

None.

Condition	Intervention	Phase
Hygiene	Drug: LACTIC ACID(ND)	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd PH_DESILSTY_FL (Lactic Acid).

Resource links provided by NLM:

Drug Information available for: Lactic acid Ammonium lactate

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Measure of the photo irritation test and the photosensitivity by using UVA irradiation and evaluation according to International Contact Dermatitis Research Group (ICDRG) scale. Evaluation of the sensibility according to the skin type. [ Time Frame: From the treatment start to the end of the study (treatment duration 5 weeks) ] [ Designated as safety issue: No ]

Enrollment:	27
Study Start Date:	June 2009
Study Completion Date:	July 2009
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Dermacyd PH_DESILSTY_FL (Lactic Acid): Experimental Dermacyd PH_DESILSTY_FL (Lactic Acid) sample will be applied like a curative. Physiologic solution and mineral oil will be also used as a control sample	Drug: LACTIC ACID(ND) Treatment duration: 5 weeks

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 pregnancy
Use of Antiinflammatory 30 days and/or immunossupression drugs for until 03 months before volunteers selection
Use of Antihistamines 30 days before selection
Disease which can cause immunosuppresion, such as diabetes, HIV
Use of photosensitivity drugs
History of sensitivity or photosensitivity for topic products
Cutaneous active disease which can modify the study results
History or activity of photodermatosis
Personal or family antecedents of cutaneous neoplasia photo induced
Presence of injury precursor of cutaneous neoplasia, such as melanociticos nevus and actinic keratosis
Intense exposure solar in the test region
Use of new drugs and/or cosmetics during the study
Previous participation in studies using the same product in test
Relevant history or confirmation of alcohol or other drugs abuse
Intolerance detected or suspected for some component of the sample tested
Medecin or sponsor employees or their close family.

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: NCT00933842

Locations

Brazil
Sanofi-aventis Administrative Office
Sao Paulo, Brazil

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Jaderson Lima

Sanofi-Aventis

More Information

No publications provided

Responsible Party:	sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:	LACAC_L_04805
Study First Received:	July 3, 2009
Last Updated:	September 4, 2009
ClinicalTrials.gov Identifier:	NCT00933842 History of Changes
Health Authority:	Brazil: National Health Surveillance Agency

ClinicalTrials.gov processed this record on September 10, 2009