Dermacyd PH_DESILSTY_FR (Lactic Acid) - Acceptability - Stay on Frutal

Sanofi

Status and phase: Completed; Phase 3

Conditions: Hygiene

Treatments: Drug: LACTIC ACID(ND)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00932945

LACAC_L_04806

Details and patient eligibility

About

Primary Objective:

To prove the safety of the gynecological formulation in normal conditions of use.

Enrollment: 32 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Exclusion criteria:

• Integral vaginal mucosa in the product analysis region
• Use the same category of cosmetics products
• Willingness in following the study procedures and to be present in the clinic at the days and scheduled time

Exclusion criteria:

• Use of Anti-inflammatory, immunossupression or antihistaminics drugs
• Allergic or atopic history to cosmetics products
• Cutaneous active disease (local and/or general) in the evaluated area
• Disease which can cause immunosuppresion, such as diabetes, HIV
• Endocrinology pathology such as thyroid gland, ovary and adrenal gland
• Intensive solar exposure until 15 days before evaluation
• Gynecological treatment until four weeks before the study
• Other reason considered by the investigator as a reason for not being included.

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: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Dermacyd PH_DESILSTY_FR (Lactic Acid)

Experimental group

Description:

Treatment duration: 21 consecutive days

Treatment:

Drug: LACTIC ACID(ND)