Dermacyd Silver Floral (Lactic Acid) - Photo Evaluation

Hygiene Clinical Trial

Official title:

Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd Silver Floral (Lactic Acid).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00932984
• Other study ID #: LACAC_L_04840
• Status: Completed
• Phase: Phase 3
• First received: July 3, 2009
• Last updated: September 13, 2010
• Start date: June 2009
• Est. completion date: July 2009

Study information

• Verified date: September 2010
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial Summary

Primary Objective:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 3 months before volunteers selection

• Disease which can cause immunosuppresion, such as diabetes, HIV

• Concomitant use of photosensitivity drugs

• History of sensitivity or photosensitivity withr 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hygiene

Intervention

Drug:
• LACTIC ACID(ND)
Dermacyd Silver Floral (Lactic Acid) sample will be applied like a curative during 5 weeks (treatment period).

Locations

Country	Name	City	State
Brazil	Sanofi-Aventis Administrative Office	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of the photo irritation test and the photosensitivity by using UVA irradiation and evaluation according International Contact Dermatitis Research Group (ICDRG) scale. Evaluation of the sensibility according to the skin type.		From the treatment start to the end of the study (treatment period 5 weeks)	No