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

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ClinicalTrials.gov Identifier: NCT00705276
Recruitment Status : Completed
First Posted : June 26, 2008
Last Update Posted : April 15, 2009
Sponsor:
Information provided by:
Sanofi

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

Condition or disease Intervention/treatment Phase
Hygiene Drug: Lactic acid (Dermacyd Femina Delicata) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd Femina Delicata
Study Start Date : April 2008
Primary Completion Date : May 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: I Drug: Lactic acid (Dermacyd Femina Delicata)



Primary Outcome Measures :
  1. 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 ]
  2. The sensibility will be evaluated according the skin type. [ Time Frame: 5 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00705276


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

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00705276     History of Changes
Other Study ID Numbers: LACAC_L_03983
First Posted: June 26, 2008    Key Record Dates
Last Update Posted: April 15, 2009
Last Verified: April 2009

Additional relevant MeSH terms:
Dermatologic Agents