Clinical Trial Results:
Monocentric Study, Phase III, for Safety Dermatological Evaluation: Acceptability With Gynecological Follow up - Dermacyd Tina Gel Tangerina Mix
Summary
|
|
EudraCT number |
2014-004661-25 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
07 Jan 2008
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
01 Apr 2016
|
First version publication date |
16 May 2015
|
Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
Trial identification
|
|||
Sponsor protocol code |
LACAC_L_03735
|
||
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
NCT00302653 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
|
|||
Sponsor organisation name |
Sanofi-aventis Farmacêutica Ltda
|
||
Sponsor organisation address |
Avenida Major Sylvio de Magalhães Padilha, 5.200 , Sao Paulo, Brazil,
|
||
Public contact |
Trial Transparency Team, Sanofi Aventis Recherche & Developpement, Contact-US@sanofi.com
|
||
Scientific contact |
Trial Transparency Team, Sanofi Aventis Recherche & Developpement, Contact-US@sanofi.com
|
||
Paediatric regulatory details
|
|||
Is trial part of an agreed paediatric investigation plan (PIP) |
No
|
||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
|
||
Results analysis stage
|
|||
Analysis stage |
Final
|
||
Date of interim/final analysis |
09 Jan 2008
|
||
Is this the analysis of the primary completion data? |
No
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
07 Jan 2008
|
||
Was the trial ended prematurely? |
No
|
||
General information about the trial
|
|||
Main objective of the trial |
To prove the safety of the gynecological formulation in normal and usual use conditions.
|
||
Protection of trial subjects |
The study was conducted by investigators experienced in the treatment of pediatric subjects. The parent(s) or guardian(s) as well as the children were fully informed of all pertinent aspects of the clinical trial as well as the possibility to discontinue at any time. A consent form was signed by the parent(s)/guardian(s).
|
||
Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
10 Dec 2007
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
No
|
||
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
Brazil: 31
|
||
Worldwide total number of subjects |
31
|
||
EEA total number of subjects |
0
|
||
Number of subjects enrolled per age group |
|||
In utero |
0
|
||
Preterm newborn - gestational age < 37 wk |
0
|
||
Newborns (0-27 days) |
0
|
||
Infants and toddlers (28 days-23 months) |
0
|
||
Children (2-11 years) |
10
|
||
Adolescents (12-17 years) |
19
|
||
Adults (18-64 years) |
2
|
||
From 65 to 84 years |
0
|
||
85 years and over |
0
|
|
|||||||
Recruitment
|
|||||||
Recruitment details |
The study was performed in one center in Brazil. A total of 31 subjects were enrolled between 10 December 2007 and 14 December 2007 | ||||||
Pre-assignment
|
|||||||
Screening details |
N/A | ||||||
Period 1
|
|||||||
Period 1 title |
overall trial (overall period)
|
||||||
Is this the baseline period? |
Yes | ||||||
Allocation method |
Not applicable
|
||||||
Blinding used |
Not blinded | ||||||
Arms
|
|||||||
Arm title
|
Lactic Acid | ||||||
Arm description |
Lactic Acid on the external genital area for 21 days | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Lactic Acid
|
||||||
Investigational medicinal product code |
|||||||
Other name |
|||||||
Pharmaceutical forms |
Vaginal liquid
|
||||||
Routes of administration |
Topical use
|
||||||
Dosage and administration details |
Liquid soap applied in the external genital area in small quantity with abundantly rinse after use
|
||||||
|
|
||||||||||||||||||||||||||||||||||||||||||||||||||||
Baseline characteristics reporting groups
|
||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Lactic Acid
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Lactic Acid on the external genital area for 21 days | |||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
End points reporting groups
|
|||
Reporting group title |
Lactic Acid
|
||
Reporting group description |
Lactic Acid on the external genital area for 21 days |
|
|||||||||||||||||
End point title |
Number of subjects with skin reaction in the tested region [1] | ||||||||||||||||
End point description |
level of skin reaction was evaluated by presence of erythema, edema, desquamation, vesiculation, ardor and itching and their intensity (mild, moderate, severe) and their causality
|
||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
21 Days
|
||||||||||||||||
Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Statistical analysis plan included only descriptive statistics. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||
Adverse events information [1]
|
|||||||||||
Timeframe for reporting adverse events |
21 days
|
||||||||||
Assessment type |
Systematic | ||||||||||
Dictionary used for adverse event reporting
|
|||||||||||
Dictionary name |
MedDRA | ||||||||||
Dictionary version |
NA
|
||||||||||
Reporting groups
|
|||||||||||
Reporting group title |
Lactic Acid
|
||||||||||
Reporting group description |
Lactic Acid for 21 days | ||||||||||
|
|||||||||||
Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||
|
|||||||||||
Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: No adverse event was reported during the trial. |
|
|||
Substantial protocol amendments (globally) |
|||
Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
|||
Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |