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Dermacyd Femina Delicata (Lactic Acid)- Photo Dermatological Evaluation of the Irritation and Sensitivity Potential

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00705276
First received: June 25, 2008
Last updated: April 14, 2009
Last verified: April 2009
History of Changes
  Purpose

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


Condition Intervention Phase
Hygiene
 Drug: Lactic acid (Dermacyd Femina Delicata)
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd Femina Delicata

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • The photo irritation test and the photosensitivity will be measured using UVA irradiation and evaluated according International Contact Dermatitis Research Group (ICDRG) scale. [ Time Frame: 5 weeks ] [ Designated as safety issue: Yes ]
  • The sensibility will be evaluated according the skin type. [ Time Frame: 5 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 26
Study Start Date: April 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: I Drug: Lactic acid (Dermacyd Femina Delicata)

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00705276

Locations
Brazil
Sanofi-aventis
São Paulo, Brazil
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Jaderson Lima, MD Sanofi
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00705276     History of Changes
Other Study ID Numbers: LACAC_L_03983
Study First Received: June 25, 2008
Last Updated: April 14, 2009
Health Authority: Brazil: National Health Surveillance Agency

ClinicalTrials.gov processed this record on May 19, 2013