Study to Evaluate the Physiological Effects on the Skin of 3 Food Supplements Versus Placebo in 40-60 Years Old Female Subjects

Nexira

Status: Enrolling

Conditions: Healthy Volunteers

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Botanicals extracts

Study type: Interventional

Funder types: Industry

Identifiers

NCT06254209

COS04

Details and patient eligibility

About

The objective is to evaluate the effects on the skin of 3 foods supplements compared to placebo after daily intake for 3 months in female subjects presenting healthy skin.

Skin parameters measured are: the firmness of the skin and other biomechanical skin properties (elasticity, tonicity, density), cellulitis visibility, radiance complexion, skin condition (microrelief, skin barrier function and moisturizing)

Full description

Study design: Monocentric, randomized, double blind, placebo controlled, 3 groups in parallel.

Enrollment: 132 estimated patients

Sex: Female

Ages: 40 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy
• Phototype II to IV (Fitzpatrick)
• Visual skin radiance score (face) ≤ 7 (0 to 9 points numeric scale)
• Tactile skin firmness score (cheek) ≤ 7 (0 to 9 points numeric scale)
• Visual cellulite score (thigh) ≥ 3 (0 to 9 points numeric scale)

Exclusion criteria

• Chronic pathology or systemic disorder
• Subjects presenting imperfections on the test sites
• Pregnant or who are planning to become pregnant
• Medication or condition that may interfere with tested outcomes

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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132 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Maltodextrin

Treatment:

Dietary Supplement: Placebo

Verum1

Experimental group

Description:

Combination of clove (Syzygium aromaticum) and immortelle (Helichrysum italicum) extracts

Treatment:

Dietary Supplement: Botanicals extracts

Verum2

Experimental group

Description:

Olive fruit extract (Olea europaea)

Treatment:

Dietary Supplement: Botanicals extracts

Verum3

Experimental group

Description:

Hibiscus flower extract (Hibiscus sabdariffa)

Treatment:

Dietary Supplement: Botanicals extracts