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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional relevant MeSH terms:
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014