Dermacyd Silver Floral (Lactic Acid) - Compatibility.

NCT00933712 | Completed Phase 3

• 1 other identifier: LACAC_L_04839
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective: To demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product Dermacyd Silver Floral

Conditions

Hygiene

Outcome Measures

Primary Outcomes (1)

• Evaluation of the absence of primary and accumulated dermical irritability and dermical sensitivity by using International Contact Dermatitis Research Group (ICDRG) scale

  from the treatment start to the end of the study (treatment period 6 weeks)

Study Arms (1)

Dermacyd Silver Floral (Lactic Acid)

EXPERIMENTAL

Dermacyd Silver Floral (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)

Interventions

LACTIC ACID(ND) DRUG

Dermacyd Silver Floral (Lactic Acid) sample will be applied like a curative for 6 weeks.

Dermacyd Silver Floral (Lactic Acid)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Lactation or pregnancy
• Use of Antiinflammatory 30 days and/or immunossupression drugs for until 3 months before volunteers selection
• Disease which can cause immunosuppresion, such as diabetes, HIV
• Use of Antihistamines 30 days before selection
• Personnel history of atopy
• History of sensitivity or irritation for topic products
• Cutaneous active disease (local and/or general) which can modify the study results
• Use of new drugs and/or cosmetics during the study
• Cutaneous reaction
• Previous participation in studies using the same product in test
• Volunteer which has immunodeficiency congenital or acquired
• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis Administrative Office

São Paulo, Brazil

Location

Study Officials

• Jaderson Lima

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 3, 2009
• First Posted: July 7, 2009
• Study Start: June 1, 2009
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: September 14, 2010

Record last verified: 2010-09

Locations

BR (1)