Dermacyd Silver Floral (Lactic Acid) - Acceptability.

Hygiene Clinical Trial

Official title:

Monocentric Study, Phase III, for Safety Dermatological Evaluation: Acceptability With Gynaecological Follow up Dermacyd Silver Floral (Lactic Acid).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00933569
• Other study ID #: LACAC_L_04838
• Status: Completed
• Phase: Phase 3
• First received: July 3, 2009
• Last updated: September 13, 2010
• Start date: June 2009
• Est. completion date: July 2009

Study information

• Verified date: September 2010
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial Summary

Primary Objective:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion 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.

Study Design

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

Related Conditions & MeSH terms

• Hygiene

Intervention

Drug:
• LACTIC ACID(ND)
treatment period: 21 consecutive days

Locations

Country	Name	City	State
Brazil	Sanofi-Aventis Administrative Office	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the absence of irritation and the good acceptability by using one specific scale which describes the intensity of the reaction.		From the treatment start to the end of the study (treatment period 21 days)	No