NCT00705744

Brief Summary

To prove the absence of photo irritation and photo sensitivity potential of the product Dermacyd Femina.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
26

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

April 1, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 26, 2008

Completed
Last Updated

April 15, 2009

Status Verified

April 1, 2009

Enrollment Period

1 month

First QC Date

June 25, 2008

Last Update Submit

April 14, 2009

Conditions

Hygiene

Outcome Measures

Primary Outcomes (2)

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

    5 weeks

  • The sensibility will be evaluated according to the skin type.

    5 weeks

Study Arms (1)

I

EXPERIMENTAL
Drug: Lactic acid (Dermacyd Femina)

Interventions

Lactic acid (Dermacyd Femina)DRUG
I

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 Anti-inflammatory and/or immuno-suppression 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

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Interventions

Lactic Acid

Intervention Hierarchy (Ancestors)

LactatesHydroxy AcidsCarboxylic AcidsOrganic Chemicals

Study Officials

  • Jaderson Lima, MD

    Sanofi

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

June 25, 2008

First Posted

June 26, 2008

Study Start

April 1, 2008

Primary Completion

May 1, 2008

Last Updated

April 15, 2009

Record last verified: 2009-04

Locations

BR(1)