Dermacyd PH_DETINBACK Tangerine Mix (Lactic Acid) - Safety.

Sanofi

Status and phase: Completed; Phase 3

Conditions: Hygiene

Treatments: Drug: Lactic Acid

Study type: Interventional

Funder types: Industry

Identifiers

NCT00783939

LACAC_L_04307

Details and patient eligibility

About

The purpose of this study is to prove the safety in normal conditions of useof the product Dermacyd PH_DETINBACK Tangerine Mix (Lactic Acid).

Enrollment: 31 patients

Sex: Female

Ages: 10 to 20 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age between 10 and 20 years old;
• Integral skin test in the region;
• Use of cosmetic product of the same category;
• Willingness in following the study procedures and to be present in the clinic at the days and scheduled time;

Exclusion criteria

• Lactation or gestational risk or gestation;
• Use of Anti-inflammatory, immunosuppression or antihistaminic drugs;
• Atopic antecedent or allergic to cosmetic product;
• Active cutaneous disease in the evaluation area;
• Diseases which cause immunology decrease, such as diabetes and HIV;
• Endocrinal pathologies;
• Intense solar exposure 15 days before the evaluation;
• Treatment until four months before the selection;

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: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

1

Experimental group

Description:

Lactic Acid (Dermacyd PH_DETINBACK Tangerine Mix)

Treatment:

Drug: Lactic Acid