Ignite Creation Date:
2024-05-06 @ 1:59 AM
Last Modification Date:
2024-10-26 @ 11:12 AM
Study NCT ID:
NCT01948531
Status:
COMPLETED
Last Update Posted:
2013-09-23
First Post:
2012-12-10
Brief Title:
Clinical Trial on a Topical Antiage Face Gel
Sponsor:
Derming SRL
Organization:
Derming SRL
Study Overview
Official Title:
Clinical and Instrumental Evaluation of a Topical Antiage Formulation for the Face
Status:
COMPLETED
Status Verified Date:
2013-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
E2912
Brief Summary:
Aim of the study is to evaluate clinically and by non-invasive instrumental evaluations the antiage activity of Gynomunal gel after one single application on the face short term evaluation and 4 weeks of repeated use twice daily long term evaluation by healthy female volunteers
It is also aim of this study to evaluate cosmetic acceptability by the volunteers and efficacy and tolerance both by investigator and volunteers
It is also aim of this study to evaluate cosmetic acceptability by the volunteers and efficacy and tolerance both by investigator and volunteers
Detailed Description:
Controlled clinical trial that foresees the application of the study product for an uninterrupted period of 4 weeks 4 visits will be performed a basal visit T0 a short term evaluation 20 minutes after the 1st product application T20min and a long term evaluation after 2 T2 - intermediate visit and 4 T4 - final visit week-treatment
The study will be conducted on 33 healthy volunteers of female sex 11 women for each of the following groups
35-44 years
45-54 years
55-65 years The volunteers accept to respect the rules fixed in the list of recruitment criteria and not to deviate from their normal life habits Moreover the month preceding the inclusion visit and during the entire period of treatment normal cleansing habits must be maintained sun and UV light exposure avoided In the case of UV exposure must be used a sun screen total block cream
Each volunteer is precisely informed about the study a consent form being completed and signed At the end of the study the investigator will declare to have informed all the volunteers participating it signing and dating the relative form
The study will be started only after Independent Ethical Committee approval It is understood that the treatment would be immediately interrupted as soon as the investigator judges it necessary
For each volunteer a Case Record Form is filled and to each one a progressive number is assigned Personal data subjects history clinical and instrumental evaluations are registered in basal conditions and at all study visits
During 3 hours before the visit the volunteer must not smoke drink coffee or alcohol Any cosmetic product can be used on the skin test area during 2 hours before the visit All measurements are performed under standard environmental conditions Temperature22-2C Relative Humidity60
Before each visit the volunteer will get acclimatized under relax conditions for at least 10-15 min
Each volunteer will report on the personal diary card all information about the date the time of study product application and a comment if necessary
At each visit the volunteers must give back the diary card to the Investigator to verify their compliance
Samples are handled by DermIng in accordance with the methods described in the company operating procedures SOP
This trial is carried out by DermIng in accordance with the methods described in its own company operating procedures SOPs The information and data on the trial are generated recorded documented and processed in accordance with the methods described in the following procedure based on ICH GCP 1996 The trial is covered by an insurance policy provided by Polichem SA to cover any damages related to the study product
Statistical plan the activity of the test product at T20min T2 and T4 will be expressed in absolute values versus baseline T0 for the entire population and for each evaluated group 35-44 yeas 45-54 years 55-65 years Moreover a comparison between groups will be carried out at each considered time Clinical data The statistical analysis of clinical data is carried out with not parametric test while the analysis of all instrumental data are carried out with parametric test
The study will be conducted on 33 healthy volunteers of female sex 11 women for each of the following groups
35-44 years
45-54 years
55-65 years The volunteers accept to respect the rules fixed in the list of recruitment criteria and not to deviate from their normal life habits Moreover the month preceding the inclusion visit and during the entire period of treatment normal cleansing habits must be maintained sun and UV light exposure avoided In the case of UV exposure must be used a sun screen total block cream
Each volunteer is precisely informed about the study a consent form being completed and signed At the end of the study the investigator will declare to have informed all the volunteers participating it signing and dating the relative form
The study will be started only after Independent Ethical Committee approval It is understood that the treatment would be immediately interrupted as soon as the investigator judges it necessary
For each volunteer a Case Record Form is filled and to each one a progressive number is assigned Personal data subjects history clinical and instrumental evaluations are registered in basal conditions and at all study visits
During 3 hours before the visit the volunteer must not smoke drink coffee or alcohol Any cosmetic product can be used on the skin test area during 2 hours before the visit All measurements are performed under standard environmental conditions Temperature22-2C Relative Humidity60
Before each visit the volunteer will get acclimatized under relax conditions for at least 10-15 min
Each volunteer will report on the personal diary card all information about the date the time of study product application and a comment if necessary
At each visit the volunteers must give back the diary card to the Investigator to verify their compliance
Samples are handled by DermIng in accordance with the methods described in the company operating procedures SOP
This trial is carried out by DermIng in accordance with the methods described in its own company operating procedures SOPs The information and data on the trial are generated recorded documented and processed in accordance with the methods described in the following procedure based on ICH GCP 1996 The trial is covered by an insurance policy provided by Polichem SA to cover any damages related to the study product
Statistical plan the activity of the test product at T20min T2 and T4 will be expressed in absolute values versus baseline T0 for the entire population and for each evaluated group 35-44 yeas 45-54 years 55-65 years Moreover a comparison between groups will be carried out at each considered time Clinical data The statistical analysis of clinical data is carried out with not parametric test while the analysis of all instrumental data are carried out with parametric test
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None