|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT01126606 |
|
Date of registration:
|
17/05/2010 |
|
Primary sponsor: |
|
|
Public title:
|
Comparative Safety and Efficacy Evaluation Between Dermacyd Silver and Glycerine Vegetal Soap Granado Traditional
|
|
Scientific title:
|
Single Center, Open, Cross-over, Phase III Study for Safety and Efficacy (Subjective and Instrumental) Comparative Evaluation Between Dermacyd Silver and Glycerine Vegetal Soap Granado Traditional for Intimate Use in Menopauses Woman. |
|
Date of first enrolment:
|
August 2010 |
|
Target sample size:
|
70 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT01126606 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
Brazil
| | | | | | | |
|
Contacts
|
|
Name:
|
Clinical Sciences & Operations |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Sanofi-Aventis |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion criteria:
- Active sex life
- Menopause for at least 6 months
- Perfect mucosa in the evaluated area
- Use the same cosmetics category
Exclusion criteria:
- Use of antiinflammatory / immunosuppression / antihistaminic drugs
- Personal history of atopy to cosmetic products
- Cutaneous active disease (local and/or general) in the evaluated area
- Disease which can cause immunosuppression, such as diabetes, HIV
- Endocrine pathology such as thyroid disease, ovarian disorder or adrenal gland
- Intense solar exposure (to get a tan) during the 15 days before the evaluation
- Gynaecologic treatment until four weeks before the evaluation
- Whatever vaginal infection detected at time of inclusion
- Other conditions considered by the investigator as reasonable to exclude the patient
from the study
The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.
Age minimum:
45 Years
Age maximum:
65 Years
Gender:
Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Hygiene
|
|
Intervention(s)
|
|
Drug: Dermacid Silver (Lactic acid)
|
|
Drug: Glycerine Vegetal Soap Granado Traditional
|
|
Primary Outcome(s)
|
|
Transepidermal water loss measurement (TEWL) and corneometry
[Time Frame: Up to Week 9]
|
|
Secondary ID(s)
|
|
LACAC_L_04937
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|