Dermacyd PH_DETINBACK Tangerine Mix (Lactic Acid) - Photo Evaluation

This study has been completed.
Information provided by:
Sanofi Identifier:
First received: October 31, 2008
Last updated: August 21, 2009
Last verified: August 2009

The purpose of this study is to demonstrate the absence of photoirritation and photosensitization potential of the product Dermacyd PHDETINBACK Tangerine Mix (Lactic Acid).

Condition Intervention Phase
Drug: Lactic Acid (Dermacyd PH_DETINBACK Tangerine Mix)
Phase 3

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
Official Title: Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd PH_DETINBACK Tangerine Mix

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: Throughout the study ] [ Designated as safety issue: No ]
  • The sensibility will be evaluated according to the skin type. [ Time Frame: Throghout the study ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: August 2008
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Lactic Acid
Drug: Lactic Acid (Dermacyd PH_DETINBACK Tangerine Mix)
Lactic Acid


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

Inclusion criteria:

  • Age between 18 and 60 years old;
  • Phototype Skin II and III;
  • 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 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 of photodermatosis active;
  • Family or personal antecedent of cutaneous photoinduced neoplasias;
  • Presence of a precursor lesion of cutaneous neoplasia, such as nevus melanocyte and queratoses actinium;
  • Intense solar exposure in the study area;
  • Use of new drugs or cosmetics during the study
  Contacts and Locations
Please refer to this study by its identifier: NCT00783666

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: NCT00783666     History of Changes
Other Study ID Numbers: LACAC_L_04309
Study First Received: October 31, 2008
Last Updated: August 21, 2009
Health Authority: Brazil: National Health Surveillance Agency processed this record on April 15, 2014