NCT00668486

Brief Summary

The purpose of this study is to prove the absence of photo irritation and photo sensitivity potential of the product Dermacyd Breeze.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for phase_3 healthy

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

January 1, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 29, 2008

Completed
Last Updated

February 10, 2009

Status Verified

February 1, 2009

Enrollment Period

1 month

First QC Date

April 23, 2008

Last Update Submit

February 9, 2009

Conditions

Healthy

Keywords

Hygiene

Outcome Measures

Primary Outcomes (1)

  • The photo irritation test and the photosensitivity will be measured using UVA irradiation and evaluated according International Contact Dermatitis Research Group (ICDRG) scale. The sensibility will be evaluated according to the skin type.

    5 weeks

Interventions

Lactic acid (Dermacid)DRUG

Eligibility Criteria

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

You may qualify if:

  • Phototype Skin II and III
  • Integral skin test in the region

You may not qualify if:

  • Lactation or gestation
  • Use of Antiinflammatory and/or immunosuppression drugs 15 days before the selection
  • Diseases which can cause immunity decrease, such as HIV, diabetes
  • Use of drug photosensitizer
  • History of sensitivity or irritation for topic products
  • Active cutaneous disease which can change the study results
  • History or photodermatosis active
  • Family or personal antecedent of cutaneous photoinduced neoplasias
  • Presence of a precursor lesion of cutaneous neoplasia, such as nevus melanocyte and keratoses actinium
  • Intense solar exposure in the study area
  • Use of new drugs or cosmetics during the study
  • 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, São Paulo, Brazil

Location

MeSH Terms

Interventions

Lactic Acid

Intervention Hierarchy (Ancestors)

LactatesHydroxy AcidsCarboxylic AcidsOrganic Chemicals

Study Officials

  • Jaderson Lima

    Sanofi-aventis administrative office Brazil

    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

April 23, 2008

First Posted

April 29, 2008

Study Start

January 1, 2008

Primary Completion

February 1, 2008

Last Updated

February 10, 2009

Record last verified: 2009-02

Locations

BR(1)