Efficacy of Marine By-product Hydrolysate on the Reduction of Atopic Dermatitis Symptoms

Not Applicable

Completed

• Conditions: Atopic Dermatitis; Eczema
• Interventions: Dietary Supplement: ACT02; Dietary Supplement: Placebo; Dietary Supplement: ACT01

• Registration Number: NCT06268847
• Lead Sponsor: Abyss Ingredients

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.

Study Timeline

• Study Start: 2024-01-09
• Study First Submitted: 2024-02-13
• Study First Submitted QC: 2024-02-13
• Study First Posted: 2024-02-20
• Primary Completion: 2024-04-02
• Study Completion: 2024-07-03
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ACT02	ACT02	The test product is a food supplement presented as a capsule containing a fish hydrolysate.
Placebo	Placebo	The placebo is a capsule with same appearance and organoleptic properties as the active product, containing no active component.
ACT01	ACT01	The test product is a food supplement presented as a capsule containing a fish hydrolysate.

Primary Outcome Measures

Name	Time	Method
SCORAD (SCORing Atopic Dermatitis)	12 weeks

Secondary Outcome Measures

Name	Time	Method
EASI (Eczema Area and Severity Index)	12 weeks
Investigator Global Assessment scale	12 weeks	To evaluate the inflammatory signs.
Corneometer	12 weeks	To measure skin hydration.
Transepidermal Water Loss (TEWL)	12 weeks	To evaluate the epidermal barrier integrity through the transepidermal water loss.
Quality of Life Index - Perceived Stress	12 weeks	Auto-questionnaire
Participant's Satisfaction	12 weeks	Auto-questionnaire

Trial Locations

Locations (1)

Eurofins; 🇪🇸 Barcelona, Spain