Atopic DermatitisNCT06268847
Efficacy of Marine By-product Hydrolysate on the Reduction of Atopic Dermatitis Symptoms
A study testing ACT01 and ACT02 in people with Atopic Dermatitis and Eczema, run by Abyss Ingredients at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis, Eczema
- What is being tested?
- ACT01 and ACT02
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteSpain
- Study dates
- 9 Jan 2024to 3 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Placebo, ACT01, ACT02
- Keywords
- SCORAD, Atopic Dermatitis, Eczema, Hydrolysate, Stress
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary 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.
ACT01Dietary supplement
2 capsules per day (2 per dose) of 300mg (dose per capsule) for 90 days of study product.
ACT02Dietary supplement
2 capsules per day (2 per dose) of 300mg (dose per capsule) for 90 days of study product.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | The placebo is a capsule with same appearance and organoleptic properties as the active product, containing no active component. Receives: Dietary Supplement: Placebo |
| ACT01 | Experimental | The test product is a food supplement presented as a capsule containing a fish hydrolysate. Receives: Dietary Supplement: ACT01 |
| ACT02 | Experimental | The test product is a food supplement presented as a capsule containing a fish hydrolysate. Receives: Dietary Supplement: ACT02 |
What is being measured
The primary outcome is the main question the study is designed to answer.
SCORAD (SCORing Atopic Dermatitis)
Measured: 12 weeks
Secondary outcomes (6)
EASI (Eczema Area and Severity Index)
Measured: 12 weeks
Investigator Global Assessment scale
To evaluate the inflammatory signs.
Measured: 12 weeks
Corneometer
To measure skin hydration.
Measured: 12 weeks
Transepidermal Water Loss (TEWL)
To evaluate the epidermal barrier integrity through the transepidermal water loss.
Measured: 12 weeks
Quality of Life Index - Perceived Stress
Auto-questionnaire
Measured: 12 weeks
Participant's Satisfaction
Auto-questionnaire
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start9 Jan 2024
- Primary completion2 Apr 2024
- Study completion3 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abyss Ingredients
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eurofins
- Responsible party
- Sponsor
- Investigators
- Frederic DEMILLIERE, MD, Principal investigator, Dermscan - Eurofins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06268847
- Sponsor's protocol ID
- DERMATIDYSS
- Status last verified
- Aug 2024
- First submitted
- 13 Feb 2024
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06268847
- Acronym / sponsor ID
- DERMATIDYSS
- Conditions
- Atopic Dermatitis, Eczema
- Keywords
- SCORAD, Atopic Dermatitis, Eczema, Hydrolysate, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Abyss IngredientsIndustry (pharma, biotech, devices)
- Collaborators
- Eurofins
- Study start
- 9 Jan 2024 (actual)
- Primary completion
- 2 Apr 2024 (actual)
- Study completion
- 3 Jul 2024 (actual)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboThe placebo is a capsule with same appearance and organoleptic properties as the active product, containing no active component. |
| ACT01 | Experimental | Dietary Supplement: ACT01The test product is a food supplement presented as a capsule containing a fish hydrolysate. |
| ACT02 | Experimental | Dietary Supplement: ACT02The test product is a food supplement presented as a capsule containing a fish hydrolysate. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- 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);
Key exclusion criteria (21 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboThe 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 | Placebo |
| ACT012 capsules per day (2 per dose) of 300mg (dose per capsule) for 90 days of study product. | Dietary supplement | ACT01 |
| ACT022 capsules per day (2 per dose) of 300mg (dose per capsule) for 90 days of study product. | Dietary supplement | ACT02 |
Primary outcome
SCORAD (SCORing Atopic Dermatitis)
Time frame: 12 weeks
6 secondary outcomes
EASI (Eczema Area and Severity Index)
Time frame: 12 weeks
Investigator Global Assessment scale
Time frame: 12 weeks
Corneometer
Time frame: 12 weeks
Transepidermal Water Loss (TEWL)
Time frame: 12 weeks
Quality of Life Index - Perceived Stress
Time frame: 12 weeks
Participant's Satisfaction
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederic DEMILLIERE, MD principal investigator
Dermscan - Eurofins
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACT01 and ACT02 in people with Atopic Dermatitis and Eczema, run by Abyss Ingredients at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SCORAD (SCORing Atopic Dermatitis) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.