Safety Dermatological Evaluation: Acceptability With Gynecological Follow up - Dermacyd Tina Gel Sweet Flower

Hygiene Clinical Trial

Official title:

Monocentric Study, Phase III, for Safety Dermatological Evaluation: Acceptability With Gynecological Follow up - Dermacyd Tina Gel Sweet Flower

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00663273
• Other study ID #: LACAC_L_03732
• Status: Completed
• Phase: Phase 3
• First received: April 18, 2008
• Last updated: January 7, 2009
• Start date: December 2007

Study information

• Verified date: January 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to demonstrate the safety of the gynecological formulation in normal and usual usage condition of Dermacyd Tina Gel Sweet Flower.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. primary completion date: January 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 10 Years to 20 Years

Eligibility

Inclusion Criteria:

• Integral skin test in the region;

Exclusion Criteria:

• Lactation or gestational risk or gestation;

• Use of Anti-inflammatory or immunosuppression drugs 1 month before the study;

• Topical medication use at the region to be treated;

• Cutaneous disease or active gynecological disease which may interfere in study results;

• Personal history of allergic disease at the area to be treated;

• Allergic or atopic history;

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hygiene

Intervention

Drug:
• Lactic acid (Dermacid)
Liquid soup to be applied in the external genital area, in a small quantity, with abundantly rinse after use, during 21 days.

Locations

Country	Name	City	State
Brazil	Sanofi-aventis	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events and their intensity and their association with the treatment.		21 days	Yes