Dermacyd Femina (Lactic Acid) - Photo Dermatological Evaluation of the Irritation and Sensitivity Potential.

Sanofi

Status and phase: Completed; Phase 3

Conditions: Hygiene

Treatments: Drug: Lactic acid (Dermacyd Femina)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00705744

LACAC_L_03982

Details and patient eligibility

About

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

Enrollment: 26 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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;
• 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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

I

Experimental group

Treatment:

Drug: Lactic acid (Dermacyd Femina)