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Dermacyd PH_DETINBACK Tangerine Mix (Lactic Acid) - Photo Evaluation

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ClinicalTrials.gov Identifier: NCT00783666
Recruitment Status : Completed
First Posted : November 3, 2008
Last Update Posted : August 25, 2009
Sponsor:
Information provided by:
Sanofi

Brief Summary:
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 or disease Intervention/treatment Phase
Hygiene Drug: Lactic Acid (Dermacyd PH_DETINBACK Tangerine Mix) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Non-Randomized
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 PH_DETINBACK Tangerine Mix
Study Start Date : August 2008
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Lactic Acid
Drug: Lactic Acid (Dermacyd PH_DETINBACK Tangerine Mix)
Lactic Acid



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: Throughout the study ]
  2. The sensibility will be evaluated according to the skin type. [ Time Frame: Throghout the study ]


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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:

  • 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

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): NCT00783666


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

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00783666     History of Changes
Other Study ID Numbers: LACAC_L_04309
First Posted: November 3, 2008    Key Record Dates
Last Update Posted: August 25, 2009
Last Verified: August 2009