Eurofins Dermscan Poland Sp. z o. o
Gdansk, Poland, 80288
NCT Number: NCT07208227
Tolerance and efficacy study of an anti aging cream on 44 subjects aged between 45 and 65 years, with sensitive skin and deep wrinkles. This study is conducted as a national, monocentric, non-randomized open trial.
Planning of the visits:
* Visit 1: Inclusion (Day 1) * Visit 2: Intermediate visit (Day 29), a window of +48 hours is allowed * Visit 3: End of study (Day 57), a window of +72 hours is allowed The maximum duration of participation for a subject is 60 days.
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Notify Me45 year–65 year
Female
Observational
Gdansk, Poland, 80288
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Criteria related to the population:
Criteria related to subject's health:
NON INCLUSION CRITERIA
Criteria related to the population:
Criteria related to subject's health:
Criteria related to investigational product application areas:
Criteria related to the COVID-19 pandemic:
Cosmetic face cream product applied once a day on face, neck and neckline.
Time frame: At the end of the study, after Last Patient Out, (after Day 57)
Global tolerance is assessed on the "tolerance population" which includes all the subjects who applied at least once investigational product.
Global assessment of the dermatological and ophthalmological tolerance is done by the investigator. This assessment allows for attribution of one of the 5 levels : excellent, very good, good, moderate, bad.
Time frame: Visit 1 (Day 1, before investigational product application), Visit 2 (Day 29) and Visit 3 (Day 57).
Ra= Average roughness Ra is the arithmetic mean of the absolute values (without differentiation between peaks and valleys) of the heights of the profile length.
Measured by 3D PRIMOS-CR SYSTEM
Time frame: Visit 1 (Day 1, before investigational product application), Visit 2 (Day 29) and Visit 3 (Day 57).
Rz= Average height of the roughness= Average relief Rz is the average of 5 single roughness depths, measured within the section ln. The single roughness depth is the difference from the highest profile peak to the deepest profile valley within a single measurement section.
Measured by 3D PRIMOS-CR SYSTEM
Time frame: Visit 1 (Day 1, before investigational product application), Visit 2 (Day 29) and Visit 3 (Day 57).
Rt= Maximum height of the roughness profile= maximum relief amplitude Rt is the height difference from the highest peak to the deepest valley within the total measurement section Measured by 3D PRIMOS-CR SYSTEM
Time frame: Visit 1 (Day 1, before investigational product application), Visit 2 (Day 29) and Visit 3 (Day 57).
Assessed by the investigator according to the BAZIN scale (7-point scale, from 0 to 6)
Time frame: Visit 1 (Day 1, before investigational product application), Visit 2 (Day 29) and Visit 3 (Day 57).
Assessed by the investigator on a 11-point scale (0 = rough skin, 10 = very smooth skin)
Time frame: Visit 1 (Day 1, before investigational product application), Visit 2 (Day 29) and Visit 3 (Day 57).
Assessed by the investigator on a 11-point scale (0 = sagged skin, 10 = very firm skin)
Time frame: Visit 1 (Day 1, before investigational product application), Visit 2 (Day 29) and Visit 3 (Day 57).
Assessed by the investigator on a 11-point scale (0 = thin and not replumped skin, 10 = very replumped skin)
Time frame: Visit 1 (Day 1, before investigational product application), Visit 2 (Day 29) and Visit 3 (Day 57).
Assessed by three jury assessors who assess the parameter on unstructured scales (corresponding to scores from 0 to 10, 0= dull, 10= radiant/luminous) based on photographs taken by Colorface
Time frame: Visit 1 (Day 1, before investigational product application), Visit 2 (Day 29) and Visit 3 (Day 57).
Assessed by three jury assessors who assess the parameter on unstructured scales (corresponding to scores from 0 to 10, 0= not bright at all, 10= very bright) based on photographs taken by Colorface
Time frame: Visit 1 (Day 1, before investigational product application), Visit 2 (Day 29) and Visit 3 (Day 57).
Assessed by three jury assessors who assess the parameter on unstructured scales (corresponding to scores from 0 to 10, 0= not even at all, 10= very even) based on photographs taken by Colorface
Time frame: Visit 1 (Day 1, before investigational product application), Visit 2 (Day 29) and Visit 3 (Day 57).
Assessed by three jury assessors who assess the parameter on unstructured scales (corresponding to scores from 0 to 10, 0= coarse, 10= fine) based on photographs taken by Colorface
Pierre Fabre Dermo Cosmetique
Industry
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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