Evaluation of Efficacy of Anthelios Sunscreen on Face Versus Usual Routine on Signs of Aging

ConditionAging

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age30-60

SponsorCosmetique Active International

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Subjects with signs of photo aging (Global score of at least 14)

All skin types

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Tested product group
Other intervention
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
Control group
Other intervention
Maintain their normal routine of using cosmetics (cleansers and moisturizers) and normal sun protection habits (if applicable)

Treatment groups

260 Participants

are divided into 2 treatment groups

Group A: Tested product groupExperimental treatment 1 intervention

Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

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

Secondary outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cosmetique Active International

Lead sponsor

Source ClinicalTrials.gov

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