Aging
Conditions
Keywords
skin aging, Anthelios UVMUNE 400 Oil Control Fluid SPF 50+, preventive effect
Brief summary
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.
Detailed description
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.
Interventions
OTHERTested product 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
OTHERControl group
Maintain their normal routine of using cosmetics (cleansers and moisturizers) and normal sun protection habits (if applicable)
Sponsors
Cosmetique Active International
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects with signs of photo aging (Global score of at least 14) * All skin types
Exclusion criteria
* Any history of significant dermatological/ophthalmological diseases or conditions or medical conditions known to alter skin appearance or physiologic response (e.g. diabetes,) which could, in the opinion of the Investigator, preclude topical application of the investigational products and/or interfere with the evaluation of the test site * Pregnant or breastfeeding women * Subject with known allergy to cosmetic products or to any ingredient of the sunscreen product
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the dermatological assessment of skin signs on the face (Global score) | Day0; Day84; Day168; Day252; Day336 | 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 \[homogeneous (0), non-homogeneous (2)\]. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dermatological assessment of skin signs on the face - Atlas Bazin, Flament (Global score) | Day0; Day84; Day168; Day252; Day336 | 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 |
Countries
Brazil
Contacts
Primary ContactRenato Moura
Outcome results
None listed