An interventional study of Placebo and ACT01 in Atopic Dermatitis and Eczema, sponsored by Abyss Ingredients. Completed at 1 site in Spain. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-21.
Sponsored by Abyss Ingredients · Not applicable, Interventional, and Supportive care
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.
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.
1,443 studies on the registry are indexed under Dermatitis, Atopic; 253 are open to participants now.
This study's enrollment of 92 is above the median of 83 across 1,143 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Abyss Ingredients is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
The placebo is a capsule with same appearance and organoleptic properties as the active product, containing no active component.
Dietary Supplement: Placebo
The test product is a food supplement presented as a capsule containing a fish hydrolysate.
Dietary Supplement: ACT01
The test product is a food supplement presented as a capsule containing a fish hydrolysate.
Dietary Supplement: ACT02
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.
2 capsules per day (2 per dose) of 300mg (dose per capsule) for 90 days of study product.
2 capsules per day (2 per dose) of 300mg (dose per capsule) for 90 days of study product.
SCORAD (SCORing Atopic Dermatitis)
Time frame: 12 weeks
EASI (Eczema Area and Severity Index)
Time frame: 12 weeks
Investigator Global Assessment scale
To evaluate the inflammatory signs.
Time frame: 12 weeks
Corneometer
To measure skin hydration.
Time frame: 12 weeks
Transepidermal Water Loss (TEWL)
To evaluate the epidermal barrier integrity through the transepidermal water loss.
Time frame: 12 weeks
Quality of Life Index - Perceived Stress
Auto-questionnaire
Time frame: 12 weeks
Participant's Satisfaction
Auto-questionnaire
Time frame: 12 weeks
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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