Dermacyd Tina Gel Sweet Flower - Photo Evaluation

Sanofi25 enrolled

Overview

The purpose of this study is to prove the absence of photo irritation and photo sensitivity potential of the product Dermacyd Tina Gel Sweet Flower.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Lactic acid (Dermacid)DRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Phototype Skin II and III * Integral skin test in the region 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 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.

Locations (1)

Sanofi-aventis administrative office

São Paulo, São Paulo, Brazil

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. The sensibility will be evaluated according to the skin type.

Time frame: 5 weeks

Data from ClinicalTrials.gov

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