This interventional, double-blind, randomized, placebo-controlled study aims to evaluate the effect of a marine by-product hydrolysate supplementation on the reduction of atopic dermatitis symptoms.
The study will be carried out with 108 subjects divided in 3 groups of 36 subjects who will be supplemented with two dosages of the food supplement or a placebo. This study intends to assess objectively and subjectively the efficacy of a food supplement claimed to improve the skin condition related to atopic dermatitis. The objectives of the study consist in the evaluation of the supplementation to improve the skin condition and symptoms on atopic dermatitis (by SCORAD), to reduce the eczema and severity on atopic dermatitis (by SCORAD and Eczema Area and Severity Index), to reduce the inflammatory signs (by Investigator Global Assessment scale), to moisturize and to improve/maintain the skin barrier.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
92
The placebo product containing mainly maltodextrin is presented in the same form as the active product, so that people handling the product cannot distinguish between them. The placebo is flavoured in order to have a fishy smell just like the active product. 2 capsules per day for 90 days of placebo.
2 capsules per day (2 per dose) of 300mg (dose per capsule) for 90 days of study product.
2 capsules per day (2 per dose) of 300mg (dose per capsule) for 90 days of study product.
Eurofins
Barcelona, Spain
SCORAD (SCORing Atopic Dermatitis)
Time frame: 12 weeks
EASI (Eczema Area and Severity Index)
Time frame: 12 weeks
Investigator Global Assessment scale
To evaluate the inflammatory signs.
Time frame: 12 weeks
Corneometer
To measure skin hydration.
Time frame: 12 weeks
Transepidermal Water Loss (TEWL)
To evaluate the epidermal barrier integrity through the transepidermal water loss.
Time frame: 12 weeks
Quality of Life Index - Perceived Stress
Auto-questionnaire
Time frame: 12 weeks
Participant's Satisfaction
Auto-questionnaire
Time frame: 12 weeks
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