Back to resultsDermacyd Femina (Lactic Acid) - Photo Dermatological Evaluation of the Irritation and Sensitivity Potential.
Primary Purpose
Hygiene
Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Lactic acid (Dermacyd Femina)
Sponsored by
About this trial
This is an interventional supportive care trial for Hygiene
Eligibility Criteria
Inclusion Criteria:
- Phototype Skin II and III;
- Integral skin test in the region;
Exclusion Criteria:
- Lactation or gestation;
- Use of Anti-inflammatory and/or immuno-suppression 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 or photodermatosis active;
- Family or personal antecedent of cutaneous photoinduced neoplasias;
- Presence of a precursor lesion of cutaneous neoplasia, such as nevus melanocyte and keratoses actinium;
- Intense solar exposure in the study area;
- 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.
Sites / Locations
- Sanofi-aventis
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
I
Arm Description
Outcomes
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
The sensibility will be evaluated according to the skin type.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00705744
Brief Title
Dermacyd Femina (Lactic Acid) - Photo Dermatological Evaluation of the Irritation and Sensitivity Potential.
Official Title
Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd Femina.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To prove the absence of photo irritation and photo sensitivity potential of the product Dermacyd Femina.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hygiene
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
I
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Lactic acid (Dermacyd Femina)
Primary Outcome Measure Information:
Title
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
5 weeks
Title
The sensibility will be evaluated according to the skin type.
Time Frame
5 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Phototype Skin II and III;
Integral skin test in the region;
Exclusion Criteria:
Lactation or gestation;
Use of Anti-inflammatory and/or immuno-suppression 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 or photodermatosis active;
Family or personal antecedent of cutaneous photoinduced neoplasias;
Presence of a precursor lesion of cutaneous neoplasia, such as nevus melanocyte and keratoses actinium;
Intense solar exposure in the study area;
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaderson Lima, MD
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-aventis
City
São Paulo
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Dermacyd Femina (Lactic Acid) - Photo Dermatological Evaluation of the Irritation and Sensitivity Potential.
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