Dermacyd Silver Floral (Lactic Acid) - Acceptability.

NCT00933569 | Completed Phase 3

• 1 other identifier: LACAC_L_04838
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hygiene

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

Dermacyd Silver Floral (Lactic Acid)

EXPERIMENTAL

Aplication of Dermacyd Silver Floral (Lactic Acid) during 21 consecutive days

Drug: LACTIC ACID(ND)

Interventions

LACTIC ACID(ND) DRUG

treatment period: 21 consecutive days

Dermacyd Silver Floral (Lactic Acid)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis Administrative Office

São Paulo, Brazil

Location

Study Officials

• Jaderson Lima

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 3, 2009
• First Posted: July 7, 2009
• Study Start: June 1, 2009
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: September 14, 2010

Record last verified: 2010-09

Locations

BR (1)