NCT06268847Befejeződött
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2024. aug. 21.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Befejeződött
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 92 (tényleges)
- Első benyújtás
- 2024. febr. 13.
- Kezdés
- 2024. jan. 9.
- Elsődleges befejezés
- 2024. ápr. 2.
- Fő szponzor
- Abyss Ingredients
- Betegségek
- Atópiás dermatitisz (ekcéma)
- NCT-szám
- NCT06268847
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Bevont résztvevők: 92
- 2024. jan. 9. és az elsődleges befejezés (2024. ápr. 2.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
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Korábbi kezelés
- 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;
Más betegség
- 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...)
Egyéb
- 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.
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 18 év – 55 év · Nem: nők és férfiak · Egészséges önkénteseket is fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Eurofins | Barcelona | Spanyolország | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.