- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07670676
The Effects of an L-histidine-Based Supplement, Eczema Topical, and Unscented Soap on Children With Eczema
Clinical Efficacy Evaluation of a Supplement Combined With Eczema Lotion + Soap on Two Groups of Children Population Having Atopic Dermatitis- Use Test Under Dermatological Control
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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-
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Gdansk, Polen
- Eurofins Dermscan Poland
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Sex: female and male;
- Age : from 1 to 12 years old;
- Phototype: I to IV;
- Type: Caucasian;
- Child having mild to moderate eczema and atopic dermatitis (including but not limited to flakiness, irritation, itching and dryness);
- No change in hygiene, cosmetics - except for the product(s) under study - during the entire study duration;
- Subjects/Subjects parent's agreeing not to change lifestyle habits of child during the study duration.
- Healthy child;
- Child whose at least one parent/legal guardian has given freely and expressly her/his informed consent;
- Child whose at least one parent/legal guardian is willing to adhere to the protocol and study procedures;
- Child with Polish citizenship.
Exclusion Criteria:
- Cutaneous pathology on the study zone (other than atopic dermatitis);
- Use of topical or systemic treatment during the previous weeks liable to interfere with the assessment of the cutaneous acceptability/efficacy of the study product (the subjects are allowed to use their topical corticosteroids during the study if needed; the information about the treatment and the number of applications must be noted in the daily log);
- Child having undergone a surgery under general anesthesia within the previous month;
- Excessive exposure to sunlight or UV-rays within the previous month;
- Child enrolled in another clinical trial during the study period.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Group 1 (ages 1-3 years)
The participant is provided with a daily powder supplement containing 0.8g of L-histidine, a topical oil to be used at least twice daily, and an unscented soap to be used twice daily.
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The intervention includes 3 products:
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Eksperimentel: Group 2 (ages 4-12 years)
The participant is provided with daily gummy supplements containing 0.8g of L-histidine, a topical lotion to be used at least twice daily, and an unscented soap to be used twice daily.
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The intervention includes 3 products: 1. Gummy supplements containing 0.8g of L-histidine.
2. A topical lotion to be used at least twice daily and as often as needed on the face and body.
3.
An unscented soap to be used twice daily (in the morning and evening) on the face and body, in replacement of the usual cleansing product.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Mål og subjektiv score af eksema sværhedsgrad
Tidsramme: 8 uger
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Ændring i eksema sværhedsgrad blev vurderet ved anvendelse af SCORAD (scoring af atopisk dermatitis).
A. For det første vurderes spredningen af eksem på forskellige kropsområder af efterforskeren og beregnes som en procent, hvor det maksimale er 100%.
B. For det andet scores intensiteten af hud rødme, hævelse, oser, ridsemærker, hudfortykning og tørhed af efterforskeren fra 0 til 3, hvor 0 er ingen, 1 er mild, 2 er moderat og 3 er alvorlig.
C. Endelig, for den subjektive score, bliver deltagerne bedt om at rapportere intensiteten af symptomer (kløe og søvnløshed) fra 0 til 10, hvor 0 ikke er kløe eller ingen søvnløshed, og 10 er den værste tænkelige kløe eller søvnløshed.
Den samlede score for den objektive scorad opnås med følgende formel: Scorad = A/5 + 7 B/2 + C
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8 uger
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Mål og subjektiv score af eksema sværhedsgrad
Tidsramme: 4 uger
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Ændring i eksema sværhedsgrad blev vurderet ved anvendelse af SCORAD (scoring af atopisk dermatitis).
A. For det første vurderes spredningen af eksem på forskellige kropsområder af efterforskeren og beregnes som en procent, hvor det maksimale er 100%.
B. For det andet scores intensiteten af hud rødme, hævelse, oser, ridsemærker, hudfortykning og tørhed af efterforskeren fra 0 til 3, hvor 0 er ingen, 1 er mild, 2 er moderat og 3 er alvorlig.
C. Endelig, for den subjektive score, bliver deltagerne bedt om at rapportere intensiteten af symptomer (kløe og søvnløshed) fra 0 til 10, hvor 0 ikke er kløe eller ingen søvnløshed, og 10 er den værste tænkelige kløe eller søvnløshed.
Den samlede score for den objektive scorad opnås med følgende formel: Scorad = A/5 + 7 B/2 + C
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4 uger
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Eczema Area Severity Index (EASI) score
Tidsramme: 8 weeks
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Change in eczema severity is assessed with the Eczema Area and Severity Index (EASI).
Skin redness, elevation, scratching, and thickening are assessed by the investigator at 4 body regions on a scale of 0 to 3, where 0 is none, 1 is mild, 2 is moderate, 3 is severe.
The EASI is the sum of these scores.
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8 weeks
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Eczema Area Severity Index (EASI) score
Tidsramme: 4 weeks
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Change in eczema severity is assessed with the Eczema Area and Severity Index (EASI).
Skin redness, elevation, scratching, and thickening are assessed by the investigator at 4 body regions on a scale of 0 to 3, where 0 is none, 1 is mild, 2 is moderate, 3 is severe.
The EASI is the sum of these scores.
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4 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Quality of Sleep
Tidsramme: 8 weeks
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Parent/guardian will fill out the Children Sleep Habit's questionnaire for their child. This questionnaire inquires about bedtime, sleep behavior, waking during the night, and morning wake-up. Possible answers include: "Always", "Usually", "Sometimes", "Rarely", and "Never". "Always" is selected if a certain behavior occurs every night, "Usually" is selected if it occurs 5 or 6 times a week, "Sometimes" if it occurs 2 to 4 times a week, "Rarely" if it occurs once a week, and "Never" if it occurs less than once a week. |
8 weeks
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Quality of Sleep
Tidsramme: 4 weeks
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Parent/guardian will fill out the Children Sleep Habit's questionnaire for their child. This questionnaire inquires about bedtime, sleep behavior, waking during the night, and morning wake-up. Possible answers include: "Always", "Usually", "Sometimes", "Rarely", and "Never". "Always" is selected if a certain behavior occurs every night, "Usually" is selected if it occurs 5 or 6 times a week, "Sometimes" if it occurs 2 to 4 times a week, "Rarely" if it occurs once a week, and "Never" if it occurs less than once a week. |
4 weeks
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Subjective Eczema Severity
Tidsramme: 8 weeks
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Parent/guardian will fill out the Patient-Oriented Eczema Measure (POEM).
This includes 7 questions about the number of days over the last week that their child experienced certain symptoms of eczema.
Possible answers include: "No Days", "1-2 Days", "3-4 Days", "5-6 Days", or "Everyday".
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8 weeks
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Subjective Eczema Severity
Tidsramme: 4 weeks
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Parent/guardian will fill out the Patient-Oriented Eczema Measure (POEM).
This includes 7 questions about the number of days over the last week that their child experienced certain symptoms of eczema.
Possible answers include: "No Days", "1-2 Days", "3-4 Days", "5-6 Days", or "Everyday".
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4 weeks
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Emotional and Behavioral Questionnaire
Tidsramme: 8 weeks
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Parent/guardian will fill out the Pediatric Symptom Checklist-17 (PSC-17) for their child.
It includes 17 questions that relate to how often a certain behaviors or mood occurs.
Answers include "Never", "Sometimes", "Often".
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8 weeks
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Emotional and Behavioral Questionnaire
Tidsramme: 4 weeks
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Parent/guardian will fill out the Pediatric Symptom Checklist-17 (PSC-17) for their child.
It includes 17 questions that relate to how often a certain behaviors or mood occurs.
Answers include "Never", "Sometimes", "Often".
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4 weeks
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- #STUU525AA1865
Plan for individuelle deltagerdata (IPD)
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IPD-planbeskrivelse
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