Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Eurofins | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | The placebo is a capsule with same appearance and organoleptic properties as the active product, containing no active component. |
|
| ACT01 | Experimental | The test product is a food supplement presented as a capsule containing a fish hydrolysate. |
|
| ACT02 | Experimental | The test product is a food supplement presented as a capsule containing a fish hydrolysate. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| SCORAD (SCORing Atopic Dermatitis) | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| EASI (Eczema Area and Severity Index) | 12 weeks | |
| Investigator Global Assessment scale | To evaluate the inflammatory signs. | 12 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Frederic DEMILLIERE, MD | Dermscan - Eurofins | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eurofins | Barcelona | 08013 | Spain |
Not provided
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D004485 | Eczema |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| ACT01 | Dietary Supplement | 2 capsules per day (2 per dose) of 300mg (dose per capsule) for 90 days of study product. |
|
| ACT02 | Dietary Supplement | 2 capsules per day (2 per dose) of 300mg (dose per capsule) for 90 days of study product. |
|
| Corneometer |
To measure skin hydration. |
| 12 weeks |
| Transepidermal Water Loss (TEWL) | To evaluate the epidermal barrier integrity through the transepidermal water loss. | 12 weeks |
| Quality of Life Index - Perceived Stress | Auto-questionnaire | 12 weeks |
| Participant's Satisfaction | Auto-questionnaire | 12 weeks |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |