NCT00785642

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below 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

August 1, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 5, 2008

Completed
Last Updated

March 6, 2009

Status Verified

March 1, 2009

Enrollment Period

1 month

First QC Date

November 4, 2008

Last Update Submit

March 5, 2009

Conditions

Hygiene

Outcome Measures

Primary Outcomes (1)

  • The absence of irritation and the good acceptability will be evaluated using one specific scale which describes the intensity of the reaction.

    From the treatment start to the end of the study

Study Arms (1)

1

EXPERIMENTAL

Dermacyd PH\_DETINLYN Tangerine Mix (Lactic Acid)

Drug: Dermacyd PH_DETINLYN Tangerine Mix (Lactic Acid)

Interventions

Dermacyd PH_DETINLYN Tangerine Mix (Lactic Acid)DRUG
1

Eligibility Criteria

Age10 Years - 20 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Integral skin test in the region;
  • Use of cosmetic product of the same category;
  • Willingness in following the study procedures and to be present in the clinic at the days and scheduled time;

You may not qualify if:

  • Lactation or gestational risk or gestation;
  • Use of Anti-inflammatory, immunosuppression or antihistaminic drugs;
  • Atopic antecedent or allergic to cosmetic product;
  • Active cutaneous disease in the evaluation area;
  • Diseases which cause immunology decrease, such as diabetes and HIV;
  • Endocrinal pathologies;
  • Intense solar exposure 15 days before the evaluation;
  • Treatment until four months before the selection
  • 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

MeSH Terms

Interventions

Lactic Acid

Intervention Hierarchy (Ancestors)

LactatesHydroxy AcidsCarboxylic AcidsOrganic Chemicals

Study Officials

  • Jaderson Lima

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 4, 2008

First Posted

November 5, 2008

Study Start

August 1, 2008

Primary Completion

September 1, 2008

Last Updated

March 6, 2009

Record last verified: 2009-03

Locations

BR(1)