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Dermacyd PH_DETINBACK Tangerine Mix (Lactic Acid) - Photo Evaluation

Sponsor
Sanofi (Industry)
Overall Status
Completed
CT.gov ID
NCT00783666
Collaborator
(none)
26
Enrollment
1
Location
1
Arm
1
Duration (Months)
25.5
Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:
Interventional
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 :
Aug 1, 2008
Actual Primary Completion Date :
Sep 1, 2008
Actual Study Completion Date :
Sep 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Lactic Acid

Drug: Lactic Acid (Dermacyd PH_DETINBACK Tangerine Mix)
Lactic Acid

Outcome Measures

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. [Throughout the study]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes 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

Locations

Site City State Country Postal Code
1 Sanofi-Aventis Administrative Office Sao Paulo Brazil

Sponsors and Collaborators

  • Sanofi

Investigators

  • Study Director: Jaderson Lima, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00783666
Other Study ID Numbers:
  • LACAC_L_04309
First Posted:
Nov 2, 2008
Last Update Posted:
Aug 25, 2009
Last Verified:
Aug 1, 2009

Study Results

No Results Posted as of Aug 25, 2009