NCT00881374

Brief Summary

Primary Objective: To demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergic potential (sensibilization) of the product Dermacyd Infantile.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2009

Shorter than P25 for phase_4

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

February 1, 2009

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 10, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 15, 2009

Completed
Last Updated

April 15, 2009

Status Verified

April 1, 2009

Enrollment Period

28 days

First QC Date

April 10, 2009

Last Update Submit

April 14, 2009

Conditions

Hygiene

Outcome Measures

Primary Outcomes (1)

  • The absence of primary and accumulated dermic irritability and dermic sensitivity will be evaluated using International Contact Dermatitis Research Group (ICDRG) scale.

    During 6 weeks (i.e. treatment period)

Study Arms (1)

Dermacyd Infantile (Lactic Acid)

EXPERIMENTAL

six weeks treatment

Drug: LACTIC ACID(ND)

Interventions

LACTIC ACID(ND)DRUG

Dermacyd Infantile (Lactic Acid)

Dermacyd Infantile (Lactic Acid)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Photo type Skin I,II, III e IV
  • Integral skin test in the region
  • Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion.

You may not qualify if:

  • Lactation or gestation
  • Use of Anti-inflammatory 30 days and/or immunosuppressant drugs during 3 months before the selection
  • Diseases which can cause immunity decrease, such as HIV, diabetes
  • Previous atopy
  • History of sensitivity or irritation for topic products
  • Active cutaneous diseases which can interfere in the study results
  • Use of new drugs and/ or cosmetics during the study
  • Cutaneous reactivity
  • Previous participation in studies, which had used the product
  • Volunteers who have immunodeficiency congenital or acquired
  • Relevant clinical history or present evidence of alcohol abuse or others drugs
  • Non tolerance to some component of the study product.
  • 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 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 10, 2009

First Posted

April 15, 2009

Study Start

February 1, 2009

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

April 15, 2009

Record last verified: 2009-04

Locations

BR(1)