NCT00932945

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2009

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 7, 2009

Completed
Last Updated

September 14, 2010

Status Verified

September 1, 2010

Enrollment Period

1 month

First QC Date

July 3, 2009

Last Update Submit

September 13, 2010

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 up to the end of the study (treatment period 21 days)

Study Arms (1)

Dermacyd PH_DESILSTY_FR (Lactic Acid)

EXPERIMENTAL

Treatment duration: 21 consecutive days

Drug: LACTIC ACID(ND)

Interventions

LACTIC ACID(ND)DRUG

Treatment duration: 21 consecutive days

Dermacyd PH_DESILSTY_FR (Lactic Acid)

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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)