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

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06268847
• Other study ID #: DERMATIDYSS
• Status: Recruiting
• Phase: N/A
• Start date: January 9, 2024
• Est. completion date: June 18, 2024

Study information

• Verified date: February 2024
• Source: Abyss Ingredients
• Contact: Elodie BOUVRET, MD
• Phone: +33777849366
• Email: elodie[@]abyss-ingredients.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 imrove the skin condition and symptoms on atopic dermatitis (by SCORAD), to reduce the eczema and severity on atopic dermatitis (by SORAD and Eczema Area and Severity Index), to reduce the inflammatory signs (by Investigator Global Assessment scale), to moisturize and to improve/maintin the skin barrier.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: June 18, 2024
• Est. primary completion date: June 18, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Dietary Supplement:
• Placebo
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.
• ACT01
2 capsules per day (2 per dose) of 300mg (dose per capsule) for 90 days of study product.
• ACT02
2 capsules per day (2 per dose) of 300mg (dose per capsule) for 90 days of study product.

Locations

Country	Name	City	State
Spain	Eurofins	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Abyss Ingredients	Eurofins

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SCORAD (SCORing Atopic Dermatitis)		12 weeks
Secondary	EASI (Eczema Area and Severity Index)		12 weeks
Secondary	Investigator Global Assessment scale	To evaluate the inflammatory signs.	12 weeks
Secondary	Corneometer	To measure skin hydration.	12 weeks
Secondary	Tewameter	To evaluate the epidermal barrier integrity through the transepidermal water loss.	12 weeks
Secondary	Quality of Life Index - Perceived Stress	Auto-questionnaire	12 weeks
Secondary	Participant's Satisfaction	Auto-questionnaire	12 weeks