An interventional study of Tested product group and Control group in Aging, sponsored by Cosmetique Active International. Recruiting at 1 site in Brazil. Open to participants aged 30 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-20.
Sponsored by Cosmetique Active International · Not applicable, Interventional, and Other
This experimental, randomized study aims at evaluating the preventative effect of a Sun Protection Factor (SPF) 50+ sunscreen (Anthelios UVMUNE 400 Fluid SPF 50+) with high Ultraviolet A (UVA) protection on clinical signs of skin aging.
The study will be conducted in compliance with the protocol, current internal procedures and in the spirit of the International Council on Harmonisation (ICH) Topic E6(R2)5 ref: EMA/CHMP/ICH/135/1995, ICH Good Clinical Practice (GCP) Addendum Nov 2016 and applicable regulatory requirement.
Statistical plan: Tx represents the values observed at Time x, for each parameter and by subgroup. Quantitative variables, or those that can reasonably be treated as such, will be summarized using the minimum, maximum, measures of central tendency such as the mean and median \& measures of dispersion such as the standard deviation (SD). Qualitative variables will be summarized in the form of counts and percentages.
For each parameter, a graphical representation of the means ±95% Confidence Interval (CI) will be produced to visually assess the evolution across time, by treatment group.
Cosmetique Active International is the lead sponsor of 54 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Volunteers using the investigational product handed over to them
Other: Tested product group
Volunteers using their own sun protection routine
Other: Control group
Apply the test product per zone at least twice a day on the face, neck (neck \& nape), décolleté and back of the hand in the morning and at midday whatever the weather conditions and the activities of the day
Maintain their normal routine of using cosmetics (cleansers and moisturizers) and normal sun protection habits (if applicable)
Change in the dermatological assessment of skin signs on the face (Global score)
Assessment of the skin parameters: Skin roughness \[absent (0), mild (2), moderate (4), severe (6)\]; Skin laxity \[absent (0), mild (2), moderate (4), severe (6)\]; Skin suppleness \[high(0), moderate (2),low (4), absent (6)\]; Skin radiance \[highly radiant (0), radiant (2), normal(4), dull(6), highly dull(8)\]; Pigmented spots \[absent (0), visible (2), highly visible (4)\]; Skin tone homogeneity \[homogeneous (0), non-homogeneous (2)\].
Time frame: Day0; Day84; Day168; Day252; Day336
Dermatological assessment of skin signs on the face - Atlas Bazin, Flament (Global score)
Assessment of the skin parameters: Forehead wrinkles (0 - 5); Crow feet wrinkles number (1 - 4); Crow feet wrinkles deepness (1 - 6); Glabellar wrinkles (0 - 5); Glabellar fine lines (0 - 5); Underneath eye wrinkle (0 - 5); Corner mouth wrinkle (0 - 6); Nasolabial fold (0 - 5); Upper lip wrinkles (0 - 6); Neck fold (0 - 5); Neck sagging (0 - 5); Ptosis (0 - 5); Eye bags (0 - 5
Time frame: Day0; Day84; Day168; Day252; Day336
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Cosmetique Active International