Clinical trial NCT06268847: Efficacy of Marine By-product Hydrolysate on the Reduction of Atopic Dermatitis Symptoms
Official title: Evaluation of the Effect of Marine By-product Hydrolysate Supplementation on the Reduction of Atopic Dermatitis Symptoms : a Randomized, Placebo-controlled, Double-blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atopic Dermatitis
Eczema
Keywords: SCORAD
Atopic Dermatitis
Eczema
Hydrolysate
Stress
Lead sponsor: Abyss Ingredients
Sponsor class: INDUSTRY
Collaborators: name: Eurofins
First posted: 2024-02-20
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Phototype: I to V;
* Subjects with atopic skin (with at least 1 visible xerosis + inflammation on the body);
* Subjects with a history background of asthma, rhinitis and/or allergic conjunctivitis;
* Subjects with SCORAD between 8 and 30 (at least 50% or more having around 8-10);
* Subjects with BMI between 20 and 30 kg/m2 (limits included);
* Subjects who have not recently participated in another similar study;
* Willingness to take supplements for the duration of the study;
* Willingness not to use products likely to interfere with the test product (collagen, hyaluronic acid, anti-stress products);
* Willingness not to change lifestyle habits;
* Willingness to avoid intensive UV exposure;
* Use of contraception that should not be modified during the study.
* Healthy subject;
* Mentally healthy subject according to Investigator's opinion;
* Subject having given his/her free informed, written consent;
* Subject agrees to taking photograph and then use the image after its pseudonymization;
* Subject willing to adhere to the protocol and study procedures;
* Subject able to understand the study;
* Subject available to attend the study visits.

Exclusion Criteria:

* Pregnant or nursing woman or woman planning to get pregnant during the study;
* Cutaneous marks on the experimental areas, which could interfere with the assessment of skin reactions;
* Subjects who have participated in the last 3 months or are currently participating in another clinical trial that may interfere with the evaluation of the primary endpoint (endpoint AD);
* Current administration of antibiotics;
* Known history of chronic disease such as congenital heart disease, liver or kidney disease, or immune deficiency;
* Topical treatment with immunomodulators (tacrolimus or pimecrolimus) in the three months prior to registration;
* Application of moisturizing products on the experimental area the day of the inclusion of the study;
* Acute or chronic infectious diseases;
* Not meet inclusion criteria;
* Those undergoing aesthetic medicine (fillers, hyaluronic acid injections, botox) that could interference in the experimental area;
* Subjects suffering Alimentary/Eating disorders (i.e. bulimia, psychogenic eating disorders, etc.)
* Subjects having frequent stomach burn;
* Allergy or intolerance to any ingredient of the experimental food supplement;
* Subjects with diabetes mellitus;
* Fish and/or iodine allergy;
* Intestinal conditions or disorders (Crohn's disease, colitis, irritable bowel syndrome, intestinal malabsorption...)
* Recent change, forecast of initiation of an hormonal treatment or change of the usual hormonal treatment during the study or 3 months before the starting of the study;
* Subject having undergone a surgery under general anesthesia within the previous month;
* Exposure in UVA ray sunbed during the 3 months before the start of the study on the experimental area or during the study;
* Subjects protected by the law;
* Subject employed by EUROFINS PRODUCT TESTING, COSMETICS \& PERSONAL CARE SPAIN, S.L.U.

Primary outcomes:
measure: SCORAD (SCORing Atopic Dermatitis)
timeFrame: 12 weeks
Secondary outcomes:
measure: EASI (Eczema Area and Severity Index)
timeFrame: 12 weeks
measure: Investigator Global Assessment scale
timeFrame: 12 weeks
measure: Corneometer
timeFrame: 12 weeks
measure: Transepidermal Water Loss (TEWL)
timeFrame: 12 weeks
measure: Quality of Life Index - Perceived Stress
timeFrame: 12 weeks
measure: Participant's Satisfaction
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Eurofins
Study officials:
affiliation: Dermscan - Eurofins
name: Frederic DEMILLIERE, MD
role: PRINCIPAL_INVESTIGATOR
References: