Dermacyd Breeze (Lactic Acid) Pocket BR - Photo Evaluation

Hygiene Clinical Trial

Official title:

Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd Breeze Pocket BR.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00784069
• Other study ID #: LACAC_L_04367
• Status: Completed
• Phase: Phase 3
• First received: October 31, 2008
• Last updated: December 18, 2008
• Start date: October 2008

Study information

• Verified date: December 2008
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial Summary

To demonstrate the absence of photoirritation and photosensitization potential of the product Dermacyd Breeze (Lactic Acid) Pocket BR.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. primary completion date: November 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion criteria:

• Age between 18 and 60 years old;

• 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 gestation;

• Use of Antiinflammatory and/or immunosuppression drugs 15 days before the selection;

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

• Use of drug photosensitizer;

• History of sensitivity or irritation for topic products;

• Active cutaneous disease which can change the study results;

• History of photodermatosis active;

• Family or personal antecedent of cutaneous photoinduced neoplasias;

• Presence of a precursor lesion of cutaneous neoplasia, such as nevus melanocyte and queratoses actinium;

• Intense solar exposure in the study area;

• 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.

Study Design

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

Related Conditions & MeSH terms

• Hygiene

Intervention

Drug:
• Lactic Acid
Lactic Acid (Dermacyd Breeze)

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	To demonstrate the absence of photoirritation and photosensitization potential of the product Dermacyd Breeze Pocket BR.		Throughout the study	No

External Links

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