NCT06268847

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Abyss Ingredients · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Atopic Dermatitis
• Eczema

Interventions

Type	Name	Description
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.
DIETARY_SUPPLEMENT	ACT01	2 capsules per day (2 per dose) of 300mg (dose per capsule) for 90 days of study product.
DIETARY_SUPPLEMENT	ACT02	2 capsules per day (2 per dose) of 300mg (dose per capsule) for 90 days of study product.

Timeline

• Start date: 2024-01-09
• Primary completion: 2024-04-02
• Completion: 2024-07-03
• First posted: 2024-02-20
• Last updated: 2024-08-21

Locations

1 site across 1 country: Spain