A Clinical Trial to Evaluate the Safety and Efficacy of a Moisturizer Body Lotion and a Lip Moisturizer in Adults of Atopic Dermatitis.
Single Center, Open-label, Non-randomized Clinical Trial to Evaluate the Safety and Efficacy of a Moisturizer Body Lotion and the Safety and Perceived Efficacy of a Lip Moisturizer in Adults With Atopic Dermatitis Presenting Dermatological Lesion.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Fitzpatrick Skin Type I to VI;
- Subjects with mild to moderate atopic dermatitis according to the SCORAD index (mild global score (up to 24) and moderate global score (between 25 to 50), presenting dermatological lesions at the initial study visit;
- Generally in good health based on medical history reported by the subject;
- Able to read, write, speak and understand Portuguese;
- Person who signed the Consent for Photograph Release and Informed Consent Form;
- Person who agrees to change their leave on body and lip moisturizers to the products of this study, and agrees to use them throughout the test period;
- Intends to complete the study and is willing and able to follow all study instructions.
Exclusion Criteria:
- Subject who attends the Study Site, on the inclusion visit, with leave on moisturizer applied on the instrumental and microbiome evaluation areas;
- Present the need for systemic treatments (as in severe atopic dermatitis cases) such as the use of oral corticosteroids or other types of systemic treatments, as assessed by the Study Physician;
- Perform topical antimicrobial therapies (such as sodium hypochlorite bath or use of topical antibiotics);
- Perform phototherapy;
- Use of antimicrobial / antibacterial / anti germ soaps or other cosmetic and hygiene products;
- Subject who has used other leave on moisturizers in the test areas (body, face and lip), with the exception of investigational products, and/or who has changed their hygiene products during the study;
- Has known allergies or adverse reactions to common topical skincare products;
- Present a skin condition that may influence the outcome of the study (e.g., psoriasis, active skin cancer, etc);
- Present skin lesions (e.g., ulcers, vesicles) or tattoos in the test areas, with the exception of lesions associated with mild or moderate atopic dermatitis;
- Has self-reported Type 1 or Type 2 diabetes or is taking insulin or another anti-diabetic medication;
- Is taking a medication that would mask an Adverse Event (AE) or confound the study results, including:
Immunosuppressive drugs within 2 months before Visit 1; Immunobiological drugs within 2 months before visit 1; Topical anti-inflammatory steroids (corticosteroids) within 15 days before the visit 1; Topical and systemic immunomodulators (such as Tacrolimus and Pimecrolimus) within 15 days before visit 1; Topical and systemic antibiotics 15 days before the visit 1; Non-steroidal anti-inflammatory drugs within 15 days before Visit 1 ; Antihistamines within 2 weeks before Visit 1;
- Is self-reported to be pregnant or planning to become pregnant during the study;
- Has a history of or a concurrent health/other condition/situation which may put the individual at significant risk, confound the study results, or interfere significantly with the individual's participation in the study;
- Participating simultaneously in another study;
- Is an employee/contractor or immediate family member of the PI, Study Site, or Sponsor;
- History of a confirmed Coronavirus disease (COVID-19) in the past 30 days;
- Contact with a person infected with COVID-19 within 14 days prior to inclusion;
- Any international travel within 14 days of inclusion, including members of the same family;
- Subjects with self-reported symptoms in the past 2 weeks: unexplained cough, shortness of breath / difficulty breathing, fatigue, body aches (headaches, muscle aches, stomach pains), conjunctivitis, loss of smell, loss of taste, lack of appetite, nausea, vomiting, diarrhea, palpitations, fever or pain / tightness in the chest; temperature ≥ 38.0 degrees Celsius/100.4 degrees Fahrenheit measured; use of fever reducers within the last 2 days of each onsite visit.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Moisturizer Body Lotion and Lip Moisturizer Regimen
All participants will receive and use both products.
|
The body lotion product is a moisturizing formulation intended for topical use on the whole body and face.
It will be applied at least twice daily.
The lip product is a moisturizing formulation intended for topical use on the lips.
It will be applied at least twice daily.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from baseline of scores of erythema to 21 ± 2 days
Tidsramme: 21 ± 2 days
|
At baseline and at 21 ± 2 days, the study physician will evaluate the whole body (including face) and the lips and score the identified erythemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify this skin reaction on the whole body (including face), and on the lips. The change from baseline will be evaluated to assess skin tolerance of both study products. |
21 ± 2 days
|
|
Change from baseline of the scores of peeling to 21 ± 2 days
Tidsramme: 21 ± 2 days
|
At baseline and at 21 ± 2 days, the study physician will evaluate the whole body (including face) and the lips and score the identified peeling according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify this skin reaction on the whole body (including face), and on the lips. The change from baseline will be evaluated to assess skin tolerance of both study products. |
21 ± 2 days
|
|
Change from baseline of the scores of blistering to 21 ± 2 days
Tidsramme: 21 ± 2 days
|
At baseline and at 21 ± 2 days, the study physician will evaluate the whole body (including face) and the lips and score the identified blistering according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify this skin reaction on the whole body (including face), and on the lips. The change from baseline will be evaluated to assess skin tolerance of both study products. |
21 ± 2 days
|
|
Change from baseline of the scores to edema to 21 ± 2 days
Tidsramme: 21 ± 2 days
|
At baseline and at 21 ± 2 days, the study physician will evaluate the whole body (including face) and the lips and score the identified edema according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify this skin reaction on the whole body (including face), and on the lips. The change from baseline will be evaluated to assess skin tolerance of both study products. |
21 ± 2 days
|
|
Procentdel af deltagere med uønskede hændelser gennem 21 ± 2 dage
Tidsramme: Op til 21 ± 2 dage
|
Procentdelen af deltagere med AE'er, alvorlige bivirkninger (SAE'er), AE'er, der fører til seponering og AE'er relateret til hudreaktioner, vil blive evalueret for hudtolerance i op til 21 ± 2 dage.
|
Op til 21 ± 2 dage
|
|
Change from baseline of scores of erythema to 5 ± 1 days
Tidsramme: 5 ± 1 days
|
At baseline and at 5 ± 1 days, the study physician will evaluate the whole body (including face) and the lips and score the identified erythemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify this skin reaction on the whole body (including face), and on the lips. The change from baseline will be evaluated to assess skin tolerance of both study products. |
5 ± 1 days
|
|
Change from baseline of the scores of peeling to 5 ± 1 days
Tidsramme: 5 ± 1 days
|
At baseline and at 5 ± 1 days, the study physician will evaluate the whole body (including face) and the lips and score the identified peeling according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify this skin reaction on the whole body (including face), and on the lips. The change from baseline will be evaluated to assess skin tolerance of both study products. |
5 ± 1 days
|
|
Change from baseline of the scores of blistering to 5 ± 1 days
Tidsramme: 5 ± 1 days
|
At baseline and at 5 ± 1 days, the study physician will evaluate the whole body (including face) and the lips and score the identified blistering according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify this skin reaction on the whole body (including face), and on the lips. The change from baseline will be evaluated to assess skin tolerance of both study products. |
5 ± 1 days
|
|
Change from baseline of the scores of edema to 5 ± 1 days
Tidsramme: 5 ± 1 days
|
At baseline and at 5 ± 1 days, the study physician will evaluate the whole body (including face) and the lips and score the identified edema according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify this skin reaction on the whole body (including face), and on the lips. The change from baseline will be evaluated to assess skin tolerance of both study products. |
5 ± 1 days
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Ændring fra baseline for sværhedsgraden af atopisk dermatitis baseret på atopisk dermatitis-indeks (SCORAD) til 21 ± 2 dage
Tidsramme: 21 ± 2 dage
|
Atopisk dermatitis (AD) sværhedsgrad baseret på SCORAD Index vil blive rapporteret ved baseline og 21 ± 2 dage. Værktøjet involverer ikke kun medicinsk vurdering, men også subjektive symptomvurderinger rapporteret af forsøgspersonen. Indekset er opdelt i følgende dele, som får en numerisk score: Ekstension (are med AD læsioner); Intensitet af reaktioner (erytem, ødem, ekssudation/skorper, afskrabninger, lichenificering og tør hud; og subjektive symptomer (kløe og søvntab). For at evaluere disse parametre anvendes en skala fra 0 til 10. Til sidst tilskrives en global klassificering af AD automatisk til hvert emne. Lavere globale score betyder, at AD-tilstanden er mindre alvorlig. Denne vurdering vil blive brugt til at bestemme effekten af fugtighedscreme bodylotion på AD-tilstanden af undersøgelsespopulationen efter en tids brug. |
21 ± 2 dage
|
|
Ændring fra baseline til 5 ± 1 dages sværhedsgrad af atopisk dermatitis baseret på SCORAD (Scoring Atopisk Dermatitis Index)
Tidsramme: 5 ± 1 dage
|
Atopisk dermatitis (AD) sværhedsgrad baseret på SCORAD Index vil blive rapporteret ved baseline og 5 ± 1 dage. Værktøjet involverer ikke kun medicinsk vurdering, men også subjektive symptomvurderinger rapporteret af forsøgspersonen. Indekset er opdelt i følgende dele, som får en numerisk score: Ekstension (are med AD læsioner); Intensitet af reaktioner (erytem, ødem, ekssudation/skorper, afskrabninger, lichenificering og tør hud; og subjektive symptomer (kløe og søvntab). For at evaluere disse parametre anvendes en skala fra 0 til 10. Til sidst tilskrives en global klassificering af AD automatisk til hvert emne. Lavere globale score betyder, at AD-tilstanden er mindre alvorlig. Denne vurdering vil blive brugt til at bestemme effekten af fugtighedscreme bodylotion på AD-tilstanden af undersøgelsespopulationen efter en tids brug. |
5 ± 1 dage
|
|
Skift fra 5 ± 1 dages sværhedsgrad af atopisk dermatitis baseret på atopisk dermatitis-indeks (SCORAD) til 21 ± 2 dage
Tidsramme: 5 ± 1 dage til 21 ± 2 dage
|
Atopisk dermatitis (AD) sværhedsgrad baseret på SCORAD Index vil blive rapporteret efter 5 ± 1 dage og 21 ± 2 dage. Værktøjet involverer ikke kun medicinsk vurdering, men også subjektive symptomvurderinger rapporteret af forsøgspersonen. Indekset er opdelt i følgende dele, som får en numerisk score: Ekstension (are med AD læsioner); Intensitet af reaktioner (erytem, ødem, ekssudation/skorper, afskrabninger, lichenificering og tør hud; og subjektive symptomer (kløe og søvntab). For at evaluere disse parametre anvendes en skala fra 0 til 10. Til sidst tilskrives en global klassificering af AD automatisk til hvert emne. Lavere globale score betyder, at AD-tilstanden er mindre alvorlig. Denne vurdering vil blive brugt til at bestemme effekten af fugtighedscreme bodylotion på AD-tilstanden af undersøgelsespopulationen efter en tids brug. |
5 ± 1 dage til 21 ± 2 dage
|
|
Mean change from baseline to 21 ± 2 days in skin hydration level of areas with and without AD lesions
Tidsramme: 21 ± 2 days
|
Skin hydration level of areas with and without AD lesions will be measured with corneometer, a recognized device that determine the water content of stratum corneum.
This measure will be used to determine the effect of the moisturizer body lotion on skin hydration of the study population after a period of use.
|
21 ± 2 days
|
|
Mean change from baseline to 5 ± 1 days in skin hydration level of areas with and without AD lesions
Tidsramme: 5 ± 1 days
|
Skin hydration level of areas with and without AD lesions will be measured with corneometer, a recognized device that determine the water content of stratum corneum.
This measure will be used to determine the effect of the moisturizer body lotion on skin hydration of the study population after a period of use.
|
5 ± 1 days
|
|
Mean change from 5 ± 1 days to 21 ± 2 days in skin hydration level of areas with and without AD lesions
Tidsramme: 5 ± 1 days to 21 ± 2 days
|
Skin hydration level of areas with and without AD lesions will be measured with corneometer, a recognized device that determine the water content of stratum corneum.
This measure will be used to determine the effect of the moisturizer body lotion on skin hydration of the study population after a period of use.
|
5 ± 1 days to 21 ± 2 days
|
|
Mean change from baseline to 21 ± 2 days in transepidermal water loss (TEWL) to assess skin barrier integrity of areas with and without AD lesions
Tidsramme: 21 ± 2 days
|
Skin barrier integrity of areas with and without AD lesions will be evaluated using a recognized device that determine the transepidermal water loss.
Lower levels of TEWL may be related to a more integrate skin barrier.
This measure will be used to determine the effect of the moisturizer body lotion on skin barrier of the study population after a period of use.
|
21 ± 2 days
|
|
Mean change from baseline to 5 ± 1 days in transepidermal water loss (TEWL) to assess skin barrier integrity of areas with and without AD lesions
Tidsramme: 5 ± 1 days
|
Skin barrier integrity of areas with and without AD lesions will be evaluated using a recognized device that determine the transepidermal water loss.
Lower levels of TEWL may be related to a more integrate skin barrier.
This measure will be used to determine the effect of the moisturizer body lotion on skin barrier of the study population after a period of use.
|
5 ± 1 days
|
|
Mean change from 5 ± 1 days to 21 ± 2 days in transepidermal water loss (TEWL) to assess skin barrier integrity of areas with and without AD lesions
Tidsramme: 5 ± 1 days to 21 ± 2 days
|
Skin barrier integrity of areas with and without AD lesions will be evaluated using a recognized device that determine the transepidermal water loss.
Lower levels of TEWL may be related to a more integrate skin barrier.
This measure will be used to determine the effect of the moisturizer body lotion on skin barrier of the study population after a period of use.
|
5 ± 1 days to 21 ± 2 days
|
|
Gennemsnitlig ændring fra baseline til 21 ± 2 dage i patientorienteret eksemmål (POEM) totalscore for at vurdere AD-alvorligheden
Tidsramme: 21 ± 2 dage
|
POEM er et enkelt, gyldigt, let fortolket og reproducerbart værktøj til at vurdere AD og monitorere aspekter af sygdommen, som er vigtige for deltagere med AD. Dette værktøj består af et spørgeskema besvaret af deltagerne med spørgsmål relateret til syv AD-symptomer (kløende hud, søvnforstyrrelser, blødende hud, hud grædende/sivende hud, afskalning af huden, revnet hud, tørhed/ruhed i huden). Deltagerne skal svare på hvert spørgsmål og specificere, hvor mange gange om ugen symptomerne opstår ved hjælp af mulighederne: ingen dag; 1 til 2 dage; 3 til 4 dage; 5 til 6 dage; hver dag. Derefter modtager hvert svar en af følgende score: 0 = ingen dage; 1= 1-2 dage; 2 = 3-4 dage; 3 = 5-6 dage 4 = hver dag. I sidste ende beregnes en samlet score ud fra summen af de 7 elementer (vurdering fra 0 til 28). Højere score korrelerer til en mere alvorlig AD-tilstand. Dette mål vil blive brugt til at bestemme effekten af fugtighedscreme bodylotion på AD-tilstanden af undersøgelsespopulationen efter en tids brug. |
21 ± 2 dage
|
|
Gennemsnitlig ændring fra baseline til 7 dage i patientorienteret eksemmål (POEM) totalscore til vurdering af AD-alvorlighed
Tidsramme: 7 dage
|
POEM er et enkelt, gyldigt, let fortolket og reproducerbart værktøj til at vurdere AD og monitorere aspekter af sygdommen, som er vigtige for deltagere med AD. Dette værktøj består af et spørgeskema besvaret af deltagerne med spørgsmål relateret til syv AD-symptomer (kløende hud, søvnforstyrrelser, blødende hud, hud grædende/sivende hud, afskalning af huden, revnet hud, tørhed/ruhed i huden). Deltagerne skal svare på hvert spørgsmål og specificere, hvor mange gange om ugen symptomerne opstår ved hjælp af mulighederne: ingen dag; 1 til 2 dage; 3 til 4 dage; 5 til 6 dage; hver dag. Derefter modtager hvert svar en af følgende score: 0 = ingen dage; 1= 1-2 dage; 2 = 3-4 dage; 3 = 5-6 dage 4 = hver dag. I sidste ende beregnes en samlet score ud fra summen af de 7 elementer (vurdering fra 0 til 28). Højere score korrelerer til en mere alvorlig AD-tilstand. Dette mål vil blive brugt til at bestemme effekten af fugtighedscreme bodylotion på AD-tilstanden af undersøgelsespopulationen efter en tids brug. |
7 dage
|
|
Gennemsnitlig ændring fra baseline til 14 dage i patientorienteret eksemmål (POEM) totalscore til vurdering af AD-alvorlighed
Tidsramme: 14 dage
|
POEM er et enkelt, gyldigt, let fortolket og reproducerbart værktøj til at vurdere AD og monitorere aspekter af sygdommen, som er vigtige for deltagere med AD. Dette værktøj består af et spørgeskema besvaret af deltagerne med spørgsmål relateret til syv AD-symptomer (kløende hud, søvnforstyrrelser, blødende hud, hud grædende/sivende hud, afskalning af huden, revnet hud, tørhed/ruhed i huden). Deltagerne skal svare på hvert spørgsmål og specificere, hvor mange gange om ugen symptomerne opstår ved hjælp af mulighederne: ingen dag; 1 til 2 dage; 3 til 4 dage; 5 til 6 dage; hver dag. Derefter modtager hvert svar en af følgende score: 0 = ingen dage; 1= 1-2 dage; 2 = 3-4 dage; 3 = 5-6 dage 4 = hver dag. I sidste ende beregnes en samlet score ud fra summen af de 7 elementer (vurdering fra 0 til 28). Højere score korrelerer til en mere alvorlig AD-tilstand. Dette mål vil blive brugt til at bestemme effekten af fugtighedscreme bodylotion på AD-tilstanden af undersøgelsespopulationen efter en tids brug. |
14 dage
|
|
Opfattet effektivitet af livskvalitet ved baseline
Tidsramme: Baseline
|
Opfattet effekt relateret til livskvalitet vil blive subjektivt evalueret af deltagerne gennem et spørgeskema med spørgsmål relateret til AD's indvirkning på livskvaliteten. Deltagerne vil besvare hvert spørgsmål ved hjælp af følgende kvalitative skala: Meget påvirket; moderat påvirket; påvirket lidt; ikke påvirket. Dette spørgeskema vil blive brugt til at evaluere virkningen af AD på livskvaliteten, før forsøgsproduktet "Moisturizer bodylotion" anvendes. Svarene for hvert spørgsmål vil blive angivet i procent. |
Baseline
|
|
Opfattet effekt i livskvaliteten efter 7 dage
Tidsramme: 7 dage
|
Opfattet effekt relateret til livskvalitet vil blive subjektivt evalueret af deltagerne gennem et spørgeskema med spørgsmål relateret til forbedringen af livskvaliteten efter 7 dages brug af fugtighedscreme bodylotion. Deltagerne vil besvare hvert spørgsmål ved hjælp af følgende kvalitative skala: Hjalp meget; moderat hjulpet; hjalp lidt; hjalp ikke. Dette spørgeskema vil blive brugt til at evaluere virkningen af fugtighedscreme bodylotion på livskvaliteten efter perioder med brug af dette produkt. Svarene for hvert spørgsmål vil blive angivet i procent. |
7 dage
|
|
Opfattet effekt i livskvaliteten efter 14 dage
Tidsramme: 14 dage
|
Opfattet effekt relateret til livskvalitet vil blive subjektivt evalueret af deltagerne gennem et spørgeskema med spørgsmål relateret til forbedringen af livskvaliteten efter 14 dages brug af fugtighedscreme bodylotion. Deltagerne vil besvare hvert spørgsmål ved hjælp af følgende kvalitative skala: Hjalp meget; moderat hjulpet; hjalp lidt; hjalp ikke. Dette spørgeskema vil blive brugt til at evaluere virkningen af fugtighedscreme bodylotion på livskvaliteten efter perioder med brug af dette produkt. Svarene for hvert spørgsmål vil blive angivet i procent. |
14 dage
|
|
Perceived Efficacy in the quality of life at 21 ± 2 days
Tidsramme: 21 ± 2 days
|
Perceived efficacy related to the quality of life will be subjectively evaluated by the participants through a questionnaire with questions related to the improvement in the quality of life after 21 ± 2 days of moisturizer body lotion usage. Participants will answer each question using the following qualitative scale: Helped very much; moderately helped; helped a little; did not helped. This questionnaire will be used to evaluate the impact of the moisturizer body lotion in the quality of life after periods of use of this product.The responses for each questions will be provided as percentages. |
21 ± 2 days
|
|
Perceived Efficacy of the moisturizer body lotion at 7 days
Tidsramme: 7 days
|
Perceived efficacy related to the attributes of moisturizer body lotions will be subjectively evaluated by the participants through a questionnaire using the following qualitative scale: totally agree; agree; neither agree, nor disagree; disagree. The responses for each questions will be provided as percentages. |
7 days
|
|
Perceived Efficacy of the moisturizer body lotion at 14 days
Tidsramme: 14 days
|
Perceived efficacy related to the attributes of moisturizer body lotions will be subjectively evaluated by the participants through a questionnaire using the following qualitative scale: totally agree; agree; neither agree, nor disagree; disagree. The responses for each questions will be provided as percentages. |
14 days
|
|
Perceived Efficacy of the moisturizer body lotion at 21 ± 2 days
Tidsramme: 21 ± 2 days
|
Perceived efficacy related to the attributes of moisturizer body lotions will be subjectively evaluated by the participants through a questionnaire using the following qualitative scale: totally agree; agree; neither agree, nor disagree; disagree. The responses for each questions will be provided as percentages. |
21 ± 2 days
|
|
Perceived Efficacy of the lip moisturizer at 7 days
Tidsramme: 7 days
|
Perceived efficacy related to the attributes of the lip moisturizer will be subjectively evaluated by the participants through a questionnaire using the following qualitative scale: totally agree; agree; neither agree, nor disagree; disagree. The answer option "Not applicable" can be used. The responses for each questions will be provided as percentages. |
7 days
|
|
Perceived Efficacy of the lip moisturizer at 21 ± 2 days
Tidsramme: 21 ± 2 days
|
Perceived efficacy related to the attributes of the lip moisturizer will be subjectively evaluated by the participants through a questionnaire using the following qualitative scale: totally agree; agree; neither agree, nor disagree; disagree. The answer option "Not applicable" can be used. The responses for each questions will be provided as percentages. |
21 ± 2 days
|
|
Determination of types and quantity of bacteria (skin microbiome) of areas with and without AD lesions at baseline
Tidsramme: Baseline
|
Skin microbiome is a group of microorganisms, including bacteria, present on the skin surface and plays an important role in AD. To evaluate the type and number of bacteria present on the surface of areas with and without AD lesions, a sample will be collected on this areas using a swab. The evaluation will be done through metagenomics, a technique that allows the determination of the types and quantity of bacteria present in an specific area. This assessment will be used to determine the effect of the moisturizer body lotion on skin microbiome after a period of use. |
Baseline
|
|
Determination of types and quantity of bacteria (skin microbiome) of areas with and without AD lesions at 21 ± 2 days
Tidsramme: 21 ± 2 days
|
Skin microbiome is a group of microorganisms, including bacteria, present on the skin surface and plays an important role in AD. To evaluate the type and number of bacteria present on the surface of areas with and without AD lesions, a sample will be collected on this areas using a swab. The evaluation will be done through metagenomics, a technique that allows the determination of the types and quantity of bacteria present in an specific area. This assessment will be used to determine the effect of the moisturizer body lotion on skin microbiome after a period of use. |
21 ± 2 days
|
|
Visual skin condition of areas with and without AD lesions at baseline captured photographically
Tidsramme: Baseline
|
Images of areas with and without AD lesions will be captured through a professional camera at baseline to visualize the skin condition of these areas before the use of moisturizer body lotion. No analysis is planned. These images will be used as a qualitative complement to the other results for moisturizer body lotion. |
Baseline
|
|
Visual skin condition of areas with and without AD lesions at 5 ± 1 days captured photographically
Tidsramme: 5 ± 1 days
|
Images of areas with and without AD lesions will be captured through a professional camera at 5 ± 1 days to visualize the skin condition of these areas after the use of moisturizer body lotion. No analysis is planned. These images will be used as a qualitative complement to the other results for moisturizer body lotion. |
5 ± 1 days
|
|
Visual skin condition of areas with and without AD lesions at 21 ± 2 days captured photographically
Tidsramme: 21 ± 2 days
|
Images of areas with and without AD lesions will be captured through a professional camera at 21 ± 2 days to visualize the skin condition of these areas after the use of moisturizer body lotion. No analysis is planned. These images will be used as a qualitative complement to the other results for moisturizer body lotion. |
21 ± 2 days
|
|
Udtalelse om oplevelsen med fugtighedscreme bodylotion efter 21 ± 2 dage
Tidsramme: 21 ± 2 dage
|
En vidnesbyrd om oplevelsen med fugtighedscreme bodylotion vil blive givet af deltagerne gennem et åbent spørgsmål i slutningen af undersøgelsen.
Formålet er at kende deres mening og erfaring med at bruge dette produkt under undersøgelsen.
|
21 ± 2 dage
|
Samarbejdspartnere og efterforskere
Publikationer og nyttige links
Generelle publikationer
- Grice EA, Kong HH, Conlan S, Deming CB, Davis J, Young AC; NISC Comparative Sequencing Program; Bouffard GG, Blakesley RW, Murray PR, Green ED, Turner ML, Segre JA. Topographical and temporal diversity of the human skin microbiome. Science. 2009 May 29;324(5931):1190-2. doi: 10.1126/science.1171700.
- Aoki V, Lorenzini D, Orfali RL, Zaniboni MC, Oliveira ZNP, Rivitti-Machado MC, Takaoka R, Weber MB, Cestari T, Gontijo B, Ramos AMC, Silva CMR, Cestari SDCP, Souto-Mayor S, Carneiro FR, Cerqueira AMM, Laczynski C, Pires MC. Consensus on the therapeutic management of atopic dermatitis - Brazilian Society of Dermatology. An Bras Dermatol. 2019 Apr;94(2 Suppl 1):67-75. doi: 10.1590/abd1806-4841.2019940210. Epub 2019 Jun 3.
- Gallo RL, Nakatsuji T. Microbial symbiosis with the innate immune defense system of the skin. J Invest Dermatol. 2011 Oct;131(10):1974-80. doi: 10.1038/jid.2011.182. Epub 2011 Jun 23.
- Stamatas GN, Capone K. New findings, and the impact of infant skin microbiota on product development. Cosmetics and Toiletries.
- Brazil. Conselho Nacional da Saúde. Resolution Nº 466, December 2012.
- Pan-American Health Organization. Good Clinical Practices: American Document. IV Pan-Americana Conference for Harmonization of Pharmaceutical Regulation, 2005.
- Blichmann CW, Serup J. Assessment of skin moisture. Measurement of electrical conductance, capacitance and transepidermal water loss. Acta Derm Venereol. 1988;68(4):284-90.
- Agner T, Serup J. Comparison of two electrical methods for measurement of skin hydration. An experimental study on an irritant patch test reaction.
- Brazil. Agência Nacional de Vigilância Sanitária (ANVISA). Guideline for Safety Assessment of Cosmetic Products. 2 edition, 2012.
- Brazil. Agência Nacional de Vigilância Sanitária (ANVISA). Resolution - RDC Nº 10, 03 March 2015.
Datoer for undersøgelser
Studer store datoer
Studiestart (Forventet)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
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
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CCSSKA003745 (Anden identifikator: Johnson & Johnson Consumer Inc.)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Atopisk dermatitis
-
Steven BakerAfsluttetKontakt Dermatitis of HandForenede Stater
-
Dicle UniversityAfsluttetBle DermatitisTyrkiet (Türkiye)
-
University of Split, School of MedicineRekrutteringKontakt Dermatitis | Kontakt Dermatitis LokalirriterendeKroatien
-
University of MalayaIkke rekrutterer endnuBle DermatitisPalæstinensiske territorier
-
University MariborRekruttering
-
TriHealth Inc.Tilmelding efter invitationBle DermatitisForenede Stater
-
Harran UniversityAfsluttet
-
Genesis Health SystemAfsluttetDermatitis, kontaktForenede Stater
-
Linda FuAvadim Technologies, Inc.Afsluttet
Kliniske forsøg med Moisturizer Body Lotion
-
Bionorica SEAfsluttetEksem-udsat hud | Atopisk diateseTyskland
-
Bausch Health Americas, Inc.Dow Pharmaceutical SciencesAfsluttetPlaque PsoriasisForenede Stater
-
Bausch Health Americas, Inc.Dow Pharmaceutical SciencesAfsluttetPlaque PsoriasisForenede Stater
-
BiogenAbbVieAfsluttetBrystkræftForenede Stater
-
University Hospital MuensterAfsluttet
-
Johnson & Johnson Consumer Inc. (J&JCI)Afsluttet
-
Therapeutics, Inc.AfsluttetPlaque PsoriasisForenede Stater
-
Therapeutics, Inc.AfsluttetPlaque PsoriasisForenede Stater
-
Bausch Health Americas, Inc.Afsluttet
-
Valeant PharmaceuticalsUkendt