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NCT06268847Completed

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

Evaluation of the Effect of Marine By-product Hydrolysate Supplementation on the Reduction of Atopic Dermatitis Symptoms : a Randomized, Placebo-controlled, Double-blind Study

Source: ClinicalTrials.gov · Last updated 21 Aug 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
92 (actual)
First submitted
13 Feb 2024
Start date
9 Jan 2024
Primary completion date
2 Apr 2024
Lead sponsor
Abyss Ingredients
NCT number
NCT06268847

What you commit to

  • Study type: Interventional
  • Participants enrolled: 92
  • From 9 Jan 2024 to the primary completion date, 2 Apr 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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

Other illness

  • Known history of chronic disease such as congenital heart disease, liver or kidney disease, or immune deficiency;
  • Acute or chronic infectious diseases;
  • Subjects suffering Alimentary/Eating disorders (i.e. bulimia, psychogenic eating disorders, etc.)
  • 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...)

Other

  • 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;
  • Application of moisturizing products on the experimental area the day of the inclusion of the study;
  • Not meet inclusion criteria;
  • Those undergoing aesthetic medicine (fillers, hyaluronic acid injections, botox) that could interference in the experimental area;
  • Subjects having frequent stomach burn;
  • Subjects protected by the law;
  • Subject employed by EUROFINS PRODUCT TESTING, COSMETICS \& PERSONAL CARE SPAIN, S.L.U.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 55 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Eurofins
Coordinator of this site? Confirm its status
BarcelonaSpainUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.