Dermacyd PH_DETINBACK (Lactic Acid) Sweet Flower - Photo Avaluation

Hygiene Clinical Trial

Official title:

Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd PH_DETINBACK (Lactic Acid) Sweet Flower

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00785720
• Other study ID #: LACAC_L_04303
• Status: Completed
• Phase: Phase 3
• First received: November 4, 2008
• Last updated: August 21, 2009
• Start date: August 2008
• Est. completion date: September 2008

Study information

• Verified date: August 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to demonstrate the absence of photoirritation and photosensitization potential of the product Dermacyd PHDETINBACK Sweet Flower.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• 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 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:
• Dermacyd PH_DETINBACK (Lactic Acid)

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	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.		Throughout the study	No