Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd Femina.

Sanofi1 site in 1 country26 target enrollmentApril 2008

ConditionsHygiene

InterventionsLactic acid (Dermacyd Femina)

DrugsLactic acid (Dermacyd Femina)

Overview

Phase: Phase 3
Intervention: Lactic acid (Dermacyd Femina)
Conditions: Hygiene
Sponsor: Sanofi
Enrollment: 26
Locations: 1
Primary Endpoint: The photo irritation test and the photosensitivity will be measured using UVA irradiation and evaluated according International Contact Dermatitis Research Group (ICDRG) scale
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

To prove the absence of photo irritation and photo sensitivity potential of the product Dermacyd Femina.

Registry

clinicaltrials.gov

Start Date

April 2008

End Date

May 2008

Last Updated

17 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Sanofi

Eligibility Criteria

Inclusion Criteria

•Phototype Skin II and III;
•Integral skin test in the region;

Exclusion Criteria

•Lactation or gestation;
•Use of Anti-inflammatory and/or immuno-suppression 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 or photodermatosis active;
•Family or personal antecedent of cutaneous photoinduced neoplasias;
•Presence of a precursor lesion of cutaneous neoplasia, such as nevus melanocyte and keratoses actinium;
•Intense solar exposure in the study area;

Arms & Interventions

I

Intervention: Lactic acid (Dermacyd Femina)

Outcomes

Primary Outcomes

The photo irritation test and the photosensitivity will be measured using UVA irradiation and evaluated according International Contact Dermatitis Research Group (ICDRG) scale

Time Frame: 5 weeks

The sensibility will be evaluated according to the skin type.

Time Frame: 5 weeks