- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00783939
Dermacyd PH_DETINBACK Tangerine Mix (Lactic Acid) - Safety.
March 5, 2009 updated by: Sanofi
Safety Dermatological Evaluation: Vaginal Mucous Irritation - Product Tested: Dermacyd PH_DETINBACK Tangerine Mix (Lactic Acid).
The purpose of this study is to prove the safety in normal conditions of useof the product Dermacyd PH_DETINBACK Tangerine Mix (Lactic Acid).
Study Overview
Study Type
Interventional
Enrollment (Actual)
31
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Sao Paulo, Brazil
- Sanofi-Aventis Administrative Office
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 20 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion criteria:
- Age between 10 and 20 years old;
- Integral skin test in the region;
- Use of cosmetic product of the same category;
- Willingness in following the study procedures and to be present in the clinic at the days and scheduled time;
Exclusion criteria:
- Lactation or gestational risk or gestation;
- Use of Anti-inflammatory, immunosuppression or antihistaminic drugs;
- Atopic antecedent or allergic to cosmetic product;
- Active cutaneous disease in the evaluation area;
- Diseases which cause immunology decrease, such as diabetes and HIV;
- Endocrinal pathologies;
- Intense solar exposure 15 days before the evaluation;
- Treatment until four months before the selection;
The above information is not intended to contain all considerations relevant to a patient¿s potential participation in a clinical trial.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Lactic Acid (Dermacyd PH_DETINBACK Tangerine Mix)
|
Lactic Acid (Dermacyd PH_DETINBACK Tangerine Mix)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The absence of irritation and the good acceptability will be evaluated using one specific scale which describes the intensity of the reaction.
Time Frame: From the treatment start to the end of the study
|
From the treatment start to the end of the study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2008
Primary Completion (Actual)
September 1, 2008
Study Completion
December 7, 2022
Study Registration Dates
First Submitted
October 31, 2008
First Submitted That Met QC Criteria
October 31, 2008
First Posted (Estimate)
November 2, 2008
Study Record Updates
Last Update Posted (Estimate)
March 6, 2009
Last Update Submitted That Met QC Criteria
March 5, 2009
Last Verified
March 1, 2009
More Information
Terms related to this study
Other Study ID Numbers
- LACAC_L_04307
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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