Dermacyd PH_DETINLYN (Lactic Acid) Tangerine Mix - Compatibility

• Sponsor: Sanofi (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00786097
• Collaborator: (none)
• Enrollment: 53
• Location: 1
• Arm: 1
• Duration (Months): 2
• Patients Per Site Per Month: 26

Study Details

Study Description

Brief Summary

The purpose of this study is to demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product Dermacyd PHDETINLYN Tangerine Mix.None.

Condition or Disease	Intervention/Treatment	Phase
Hygiene	Drug: Dermacyd PH_DETINLYN (Lactic Acid)	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 53 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Study for Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermical Irritability, Dermical Sensitivity) of Dermacyd PH_DETINLYN (Lactic Acid) Tangerine Mix
• Study Start Date: Jul 1, 2008
• Actual Primary Completion Date: Sep 1, 2008
• Actual Study Completion Date: Sep 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Dermacyd PH_DETINLYN (Lactic Acid)	Drug: Dermacyd PH_DETINLYN (Lactic Acid)

Outcome Measures

Primary Outcome Measures

1. The absence of primary and accumulated dermical irritability and dermical sensitivity will be evaluated using International Contact Dermatitis Research Group (ICDRG) scale. [Throughout the study]

Eligibility Criteria

Criteria

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

Inclusion criteria:

• Phototype Skin I,II, III e 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 inclusion:

• Lactation or gestation

• Use of Antiinflammatory and/or immunossupression drugs

• Personnel history of atopy;

• History of sensitivity or irritation for topic products;

• Active cutaneous disease;

• 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

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: NCT00786097
• Other Study ID Numbers: LACAC_L_04305
• First Posted: Nov 5, 2008
• Last Update Posted: Aug 25, 2009
• Last Verified: Aug 1, 2009

Study Results

No Results Posted as of Aug 25, 2009