Dermacyd Infantile (Lactic Acid) - Photo Evaluation.

• Sponsor: Sanofi (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00881348
• Collaborator: (none)
• Enrollment: 25
• Location: 1
• Arm: 1
• Duration (Days): 28
• Patients Per Site Per Month: 27.2

Study Details

Study Description

Brief Summary

Primary Objective:

To demonstrate the absence of photo irritation and photosensitization potential of the product Dermacyd Infantile (Lactic Acid).

Condition or Disease	Intervention/Treatment	Phase
Hygiene	Drug: LACTIC ACID(ND)	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 25 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd Infantile (Lactic Acid).
• Study Start Date: Feb 1, 2009
• Actual Primary Completion Date: Mar 1, 2009
• Actual Study Completion Date: Mar 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dermacyd infantile (Lactic Acid) 5 weeks treatment	Drug: LACTIC ACID(ND); Dermacyd infantile (Lactic Acid)

Outcome Measures

Primary Outcome Measures

1. 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. [During 5 weeks (i.e. treatment period)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion criteria:

• Phototype Skin I, II, III and IV

• 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:

• Use of Anti-inflammatory, immunosuppressant or anti-histaminic drugs

• Lactation or gestation

• Use of Anti-inflammatory drugs 30 days and/or immunosuppressant drugs during 3 months before the selection

• Diseases which can cause immunity decrease, such as HIV, diabetes

• Previous atopy

• History of sensitivity or irritation for topic products

• Active cutaneous diseases which can interfere in the study results

• Use of new drugs and/ or cosmetics during the study

• Cutaneous reactivity

• Previous participation in studies, which had used the product

• Volunteers who have immunodeficiency congenital or acquired.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sanofi-Aventis Administrative Office	Sao Paulo		Brazil

Sponsors and Collaborators

• Sanofi

Investigators

• Study Director: Jaderson Lima, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00881348
• Other Study ID Numbers: LACAC_L_04680
• First Posted: Apr 15, 2009
• Last Update Posted: Apr 15, 2009
• Last Verified: Apr 1, 2009

Study Results

No Results Posted as of Apr 15, 2009