Dermacyd PH_DETINBACK Tangerine Mix (Lactic Acid)- Compatibility

Sanofi

Status and phase: Completed; Phase 3

Conditions: Hygiene

Treatments: Drug: Lactic Acid (Dermacyd PH_DETINBACK Tangerine Mix)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00784160

LACAC_L_04308

Details and patient eligibility

About

The purpose of this study is to demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product Dermacyd PHDETINBACK Tangerine Mix (Lactic Acid).

Enrollment: 53 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age between 18 and 60 years old;
• Phototype Skin I,II, III e IV;
• 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;
• Personnel history of atopy;
• History of sensitivity or irritation for topic products;
• Active cutaneous disease;
• Use of new drugs or cosmetics during the study;

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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53 participants in 1 patient group

1

Experimental group

Description:

Lactic Acid

Treatment:

Drug: Lactic Acid (Dermacyd PH_DETINBACK Tangerine Mix)