Dermacyd PH_DETINLYN (Lactic Acid) Sweet Flower - Compatibility

This study has been completed.
Information provided by:
Sanofi Identifier:
First received: November 4, 2008
Last updated: August 21, 2009
Last verified: August 2009

To demonstrate the absence of irritation potential (primary dermical irritability and cumulated dermical irritability) and allergy (sensibilization) of the product Dermacyd PHDETINLYN Sweet Flower.

Condition Intervention Phase
Drug: Dermacyd PH_DETINLYN (Lactic Acid)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Primary Purpose: Supportive Care
Official Title: Study for Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermical Irritability, Dermical Sensitivity) of Dermacyd PH_DETINLYN (Lactic Acid) Sweet Flower

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Enrollment: 53
Study Start Date: July 2008
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Dermacyd PH_DETINLYN (Lactic Acid)
Drug: Dermacyd PH_DETINLYN (Lactic Acid)


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

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 immunossupression drugs
  • Personnel history of atopy

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  • 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.
  Contacts and Locations
Please refer to this study by its identifier: NCT00785655

Sanofi-Aventis Administrative Office
Sao Paulo, Brazil
Sponsors and Collaborators
Study Director: Jaderson Lima Sanofi
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis Identifier: NCT00785655     History of Changes
Other Study ID Numbers: LACAC_L_04299
Study First Received: November 4, 2008
Last Updated: August 21, 2009
Health Authority: Brazil: National Health Surveillance Agency processed this record on April 21, 2014