Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00783939
Other study ID # LACAC_L_04307
Secondary ID
Status Completed
Phase Phase 3
First received October 31, 2008
Last updated March 5, 2009
Start date September 2008

Study information

Verified date March 2009
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority Brazil: National Health Surveillance Agency
Study type Interventional

Clinical Trial Summary

The purpose of this study is to prove the safety in normal conditions of useof the product Dermacyd PH_DETINBACK Tangerine Mix (Lactic Acid).


Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date
Est. primary completion date September 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 10 Years to 20 Years
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Brazil Sanofi-Aventis Administrative Office Sao Paulo

Sponsors (1)

Lead Sponsor Collaborator
Sanofi

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary The absence of irritation and the good acceptability will be evaluated using one specific scale which describes the intensity of the reaction. From the treatment start to the end of the study No
See also
  Status Clinical Trial Phase
Completed NCT02342860 - The Impact of Improved WASH in Schools on Absence, Diarrhea and Helminth Infection in Lao PDR N/A
Completed NCT00783640 - Dermacyd Femina (Lactic Acid) Pocket BR - Photo Evaluation Phase 3
Completed NCT00783861 - Dermacyd Femina (Lactic Acid) Pocket BR - Compatibility Phase 3
Completed NCT00784069 - Dermacyd Breeze (Lactic Acid) Pocket BR - Photo Evaluation Phase 3
Completed NCT00784121 - Dermacyd Breeze (Lactic Acid) Pocket BR - Compatibility Phase 3
Completed NCT00793026 - Dermacyd Breeze Pocket BR (Lactic Acid) - Acceptability Phase 3
Completed NCT00794612 - Dermacyd Femina Pocket BR (Lactic Acid)- Acceptability. Phase 3
Completed NCT04382690 - Behavioral Determinants That May Influence People's Hand-hygiene and Environment Disinfecting
Completed NCT00761800 - Dermacyd Teen Care Tangerina Mix - Compatibility Phase 3
Completed NCT00497692 - Topic Compatibility Lactoserum (Dermacyd Delicata - New Fragrance) Phase 4
Completed NCT00497783 - Acceptability Lactoserum (Dermacyd Delicata - New Fragrance) Phase 4
Completed NCT00371852 - Topic Compatibility Dermacyd Wipes - Lactoserum - Hygiene Phase 3
Completed NCT00380991 - Topic Compatibility Dermacyd Delicata - New Fragrance - Lactoserum - Hygiene Phase 3
Completed NCT03032887 - Reducing Visitors- and Personnel-associated Infection Risk on Perinatal Care Station N/A
Completed NCT00881270 - Dermacyd Infantile - Acceptability. Phase 4
Completed NCT00679562 - Lactacyd Radiance (Lactic Acid) Prophetic Patch Test Phase 2
Completed NCT00933907 - Dermacyd PH_DESILSTY_FR (Lactic Acid) - Compatibility - Stay on Frutal Phase 3
Completed NCT00933257 - Dermacyd PH_DESILSTY_FR (Lactic Acid) - Photo Evaluation - Stay on Frutal Phase 3
Completed NCT00932984 - Dermacyd Silver Floral (Lactic Acid) - Photo Evaluation Phase 3
Completed NCT00933504 - Dermacyd Silver Floral (Lactic Acid) - Compatibility - Stay on Floral Phase 3