Dermacyd PH_DETINBACK (Lactic Acid) Sweet Flower - Compatibility

Verified by: Sanofi-Aventis, August 2009
First Received: November 4, 2008 | Last Updated: August 21, 2009 | Phase: Phase 3 | Start Date: July 2008
Overall Status: Completed | Estimated Enrollment: 53
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The purpose of this study is to demonstrate the absence of irritation potential (primary dermical irritability and cumulated dermical irritability) and allergy (sensibilization) of the product Dermacyd PHDETINBACK Sweet Flower...

Brief Summary

Official Title: “Study for Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermical Irritability, Dermical Sensitivity) of Dermacyd PH_DETINBACK (Lactic Acid) Sweet Flower”

The purpose of this study is to demonstrate the absence of irritation potential (primary dermical irritability and cumulated dermical irritability) and allergy (sensibilization) of the product Dermacyd PHDETINBACK Sweet Flower.

  • Study Type: Interventional
  • Study Design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
  • Study Primary Completion Date: September 2008

Intervention(s) in this Clinical Trial

  • Drug: Dermacyd PH_DETINBACK (Lactic Acid)

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: 1
    • Dermacyd PH_DETINBACK (Lactic Acid)

Outcome Measures for this Clinical Trial

Primary Measures

  • The absence of primary and accumulated dermical irritability and dermical sensitivity will be evaluated using International Contact Dermatitis Research Group (ICDRG) scale.
    • Time Frame: Throughout the study
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion criteria:

  • Phototype Skin I,II, III e IV
  • Integral skin test in the region;
  • Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion;

Exclusion criteria:

  • Lactation or gestation
  • Use of Antiinflammatory and/or immunosuppression drugs
  • Personnel history of atopy;
  • History of sensitivity or irritation for topic products;
  • Active cutaneous disease;
  • 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.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 60 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Clinical Trial Investigator Information

Lead Investigator: Sanofi-Aventis Industry

Overall Clinical Trial Officials and Contacts

Jaderson Lima Study Director Sanofi-Aventis  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00785681

Study ID Number: LACAC_L_04302

ClinicalTrials.gov Identifier: NCT00785681

Health Authority: Brazil: National Health Surveillance Agency

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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00785681