Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00933569
Other study ID # LACAC_L_04838
Secondary ID
Status Completed
Phase Phase 3
First received July 3, 2009
Last updated September 13, 2010
Start date June 2009
Est. completion date July 2009

Study information

Verified date September 2010
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority Brazil: National Health Surveillance Agency
Study type Interventional

Clinical Trial Summary

Primary Objective:

To prove the safety of the gynaecological formulation in normal conditions of use.


Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date July 2009
Est. primary completion date July 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 65 Years
Eligibility Inclusion criteria:

- Integral vaginal mucosa in the product analysis region

- Use the same category of cosmetics products

- Willingness in following the study procedures and to be present in the clinic at the days and scheduled time

Exclusion criteria:

- Use of Anti-inflammatory, immunossupression or antihistaminics drugs

- Allergic or atopic history to cosmetics products

- Cutaneous active disease (local and/or general) in the evaluated area

- Disease which can cause immunosuppresion, such as diabetes, HIV

- Endocrinology pathology such as thyroid gland, ovary and adrenal gland

- Intensive solar exposure until 15 days before evaluation

- Gynecological treatment until four weeks before the study

- Other reason considered by the investigator as a reason for not being included.

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 Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
LACTIC ACID(ND)
treatment period: 21 consecutive days

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 Evaluation of the absence of irritation and the good acceptability by using one specific scale which describes the intensity of the reaction. From the treatment start to the end of the study (treatment period 21 days) 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 NCT00783939 - Dermacyd PH_DETINBACK Tangerine Mix (Lactic Acid) - Safety. Phase 3
Completed NCT00784121 - Dermacyd Breeze (Lactic Acid) Pocket BR - Compatibility Phase 3
Completed NCT00783861 - Dermacyd Femina (Lactic Acid) Pocket BR - Compatibility Phase 3
Completed NCT00783640 - Dermacyd Femina (Lactic Acid) Pocket BR - Photo Evaluation Phase 3
Completed NCT00784069 - Dermacyd Breeze (Lactic Acid) Pocket BR - Photo Evaluation Phase 3
Completed NCT00794612 - Dermacyd Femina Pocket BR (Lactic Acid)- Acceptability. Phase 3
Completed NCT00793026 - Dermacyd Breeze 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 NCT00380991 - Topic Compatibility Dermacyd Delicata - New Fragrance - Lactoserum - Hygiene Phase 3
Completed NCT00371852 - Topic Compatibility Dermacyd Wipes - 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 NCT00933413 - Dermacyd Silver Frutal (Lactic Acid) - Acceptability. Phase 3
Completed NCT00933946 - Dermacyd Silver Frutal (Lactic Acid) - Compatibility. Phase 3
Completed NCT00933907 - Dermacyd PH_DESILSTY_FR (Lactic Acid) - Compatibility - Stay on Frutal Phase 3