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

Last updated: August 19, 2024
Sponsor: Abyss Ingredients
Overall Status: Completed

Phase

N/A

Condition

Dermatitis, Atopic

Atopic Dermatitis

Allergy

Treatment

ACT02

Placebo

ACT01

Clinical Study ID

NCT06268847
DERMATIDYSS
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Phototype: I to V;

  • Subjects with atopic skin (with at least 1 visible xerosis + inflammation on thebody);

  • Subjects with a history background of asthma, rhinitis and/or allergicconjunctivitis;

  • 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 itspseudonymization;

  • Subject willing to adhere to the protocol and study procedures;

  • Subject able to understand the study;

  • Subject available to attend the study visits.

Exclusion

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 assessmentof skin reactions;

  • Subjects who have participated in the last 3 months or are currently participatingin another clinical trial that may interfere with the evaluation of the primaryendpoint (endpoint AD);

  • Current administration of antibiotics;

  • Known history of chronic disease such as congenital heart disease, liver or kidneydisease, or immune deficiency;

  • Topical treatment with immunomodulators (tacrolimus or pimecrolimus) in the threemonths prior to registration;

  • Application of moisturizing products on the experimental area the day of theinclusion 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 eatingdisorders, 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 bowelsyndrome, intestinal malabsorption...)

  • Recent change, forecast of initiation of an hormonal treatment or change of theusual hormonal treatment during the study or 3 months before the starting of thestudy;

  • Subject having undergone a surgery under general anesthesia within the previousmonth;

  • Exposure in UVA ray sunbed during the 3 months before the start of the study on theexperimental 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

Total Participants: 92
Treatment Group(s): 3
Primary Treatment: ACT02
Phase:
Study Start date:
January 09, 2024
Estimated Completion Date:
July 03, 2024

Study 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.

Connect with a study center

  • Eurofins

    Barcelona, 08013
    Spain

    Site Not Available

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