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

NCT06268847 | Completed

• 1 other identifier: DERMATIDYSS
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis; Eczema

Keywords

SCORAD; Atopic Dermatitis; Eczema; Hydrolysate; Stress

Outcome Measures

Primary Outcomes (1)

• SCORAD (SCORing Atopic Dermatitis)

  12 weeks

Secondary Outcomes (6)

• EASI (Eczema Area and Severity Index)

  12 weeks

• Investigator Global Assessment scale

  12 weeks

• Corneometer

  12 weeks

• Transepidermal Water Loss (TEWL)

  12 weeks

• Quality of Life Index - Perceived Stress

  12 weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

The placebo is a capsule with same appearance and organoleptic properties as the active product, containing no active component.

Dietary Supplement: Placebo

ACT01

EXPERIMENTAL

The test product is a food supplement presented as a capsule containing a fish hydrolysate.

Dietary Supplement: ACT01

ACT02

EXPERIMENTAL

The test product is a food supplement presented as a capsule containing a fish hydrolysate.

Dietary Supplement: ACT02

Interventions

Placebo DIETARY_SUPPLEMENT

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.

Placebo

ACT01 DIETARY_SUPPLEMENT

2 capsules per day (2 per dose) of 300mg (dose per capsule) for 90 days of study product.

ACT01

ACT02 DIETARY_SUPPLEMENT

2 capsules per day (2 per dose) of 300mg (dose per capsule) for 90 days of study product.

ACT02

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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;
• Acute or chronic infectious diseases;
• 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;

Sponsors & Collaborators

• Abyss Ingredients: lead
• Eurofins: collaborator

Study Sites (1)

Eurofins

Barcelona, 08013, Spain

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Frederic DEMILLIERE, MD

  Dermscan - Eurofins

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: February 20, 2024
• Study Start: January 9, 2024
• Primary Completion: April 2, 2024
• Study Completion: July 3, 2024
• Last Updated: August 21, 2024

Record last verified: 2024-08

Locations

ES (1)