Atopic Dermatitis, Psoriasis
Conditions
Keywords
Vitamin D3, Atopic Dermatitis, Antimicrobial Peptide Expression
Brief summary
This study will examine whether administration of oral Vitamin D3 given over 21 days will change the antimicrobial peptide expression in the skin or saliva of subjects with Atopic Dermatitis (AD). This study will help researchers determine if the lack of the expression of antimicrobial peptides in individuals with AD plays a role in the susceptibility to eczema vaccinatum (EV).
Detailed description
Atopic Dermatitis (AD) is a chronic inflammatory skin disorder in which the skin becomes extremely itchy and is susceptible to recurrent skin infections. AD is thought to occur from a combination of immunological, genetic, and environmental factors. Individuals with AD are at risk for developing a severe and widely disseminated infection called eczema vaccinatum (EV). EV is caused when the live attenuated vaccinia virus in the vaccine reproduces and spreads throughout the body. Individuals with AD lack certain antimicrobial peptides, specifically cathelicidins. This trial also includes a sub-study with individuals who have psoriasis. Psoriasis is also an immune-mediated skin disease, and is characterized by scaling skin and inflammation (pain, swelling, heat, and redness). Most psoriasis cause patches of thick, red skin with silvery scales. These patches can itch or feel sore. This sub-study will provide additional information on psoriatic responses to oral vitamin D. (Originally listed separately as ADVN-CATH-03-01).
Interventions
DRUGVitamin D3
Administration of oral vitamin D3 at 4000IU
DRUGPlacebo
Administration of oral Vitamin D3 placebo
Sponsors
Consortium of Food Allergy Research
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
(Main Study): * Definitive diagnosis of AD for at least 6 months, stringently diagnosed using the ADVN Standard Diagnostic Criteria, and has lesional skin present OR is a non-atopic healthy control subject with no personal or family history of food allergy, AD, asthma, or allergic rhinitis * Residing in the US. Inclusion Criteria (Sub-Study): * Definitive diagnosis of typical plaque psoriasis for at least 6 months, stringently diagnosed using the ADVN Standard Diagnostic Criteria; or is an AD or non-atopic healthy control subject participating in the main protocol ADVN CATH 03. * Residing in the US.
Exclusion criteria
(Main Study): * Presence of atopy without stringent AD features, allowing only a presumptive diagnosis of AD * Presence of AD with exfoliative erythroderma * Presence of psoriasis * Pregnant or lactating females * Existence of ongoing dental disease (e.g., gingivitis) * History of bleeding disorders * Presence of severe AD that would be exacerbated by withholding of topical corticosteroids, oral or topical antibiotics, topical or systemic antihistamines, oral antivirals, immune enhancers (e.g., imiquimod), or topical calcineurin inhibitors within 7 days of Study Visit 2 (Baseline) and throughout the course of the trial * Receiving systemic immunosuppressives, chemotherapeutic agents, anti-inflammatory biologics (e.g., alefacept, etanercept), systemic, oral, injectable or inhaled steroids, vitamin D supplements (more than 400 IU daily) or oral calcineurin inhibitors 30 days prior to the Study Visit 2 (Baseline) or anytime during the course of the trial * Using topical corticosteroids, oral or topical antibiotics, oral antivirals, immune enhancers (e.g., imiquimod), topical or systemic antihistamines, or topical calcineurin inhibitors within 7 days of Study Visit 2 (Baseline) and during the course of the trial * Receiving phototherapy (e.g., UVB, psoralen plus ultraviolet light A \[PUVA\]) within 30 days of Study Visit 2 (Baseline) and during the course of the trial * Having autoimmune or immunodeficiency disease * Presence of active systemic fungal (excluding nail fungus), bacterial, or viral infections * History of or presence of active systemic malignancy, excluding uncomplicated non-melanoma skin cancer * Mental illness or history of drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements * Inability or unwillingness of a participant to give written informed consent * Diabetes * Certain screening laboratory values not within normal limits, which would include calcium, serum PTH, and serum creatinine * History of kidney disease or kidney stones * Currently taking barbiturates such as phenobarbital (Luminal) * Currently taking carbamazine (Tegretol), digoxin, phenytoin (Dilantin) or fosphenytoin (cerebyx) * Currently taking diuretics such as thiazide diuretics, calcium channel blockers, or beta-blockers * Currently taking magnesium-containing antacids, mineral oil, cholestyramine (Questran), colestipol(Colestid), orlistat (xenical), the fat substitute Olestra, cod liver oil, fish oil, or omega 3 fatty acids * Currently taking oral antifungals such as ketoconazole * History of serious or life-threatening anaphylactic reaction to tape or adhesives * Lidocaine allergy * History of or active hyperparathyroidism, sarcoid, tuberculosis or lymphoma.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline on Day 21 in Relative Abundance of HBD-3 mRNA in Lesional and Non-Lesional Skin for Psoriatic Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo | Baseline to Day 21 | Human Beta-defensin 3 (HBD-3) Messenger Ribonucleic acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = \[(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)\]. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. There is no known clinical correlation between HBD-3 and psoriasis. |
| Change From Baseline on Day 21 in Relative Abundance of CAMP mRNA in Lesional and Non-Lesional Skin for Psoriatic Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo | Baseline to Day 21 | Cathelicidin (CAMP) messenger ribonucleic acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = \[(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)\]. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline, Cathelicidin abundance in psoriasis has been hypothesized to correlate with increased inflammation. No direct clinical correlation is known. |
| Change From Baseline on Day 21 in Relative Abundance of HBD-3 mRNA in Lesional and Non-Lesional Skin for Atopic Dermatitis (AD) Participants Who Received Oral Vitamin D3 Versus Vitamin D3-Placebo | Baseline to Day 21 | Human Beta-defensin 3 (HBD-3) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies as measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = \[(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)\]. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. HBD-3 amount is clinically significant as it is necessary to resist infection. HBD-3 amount is not known to be clinically relevant to the clinical signs of dermatitis associated with AD. |
| Change From Baseline on Day 21 in Relative Abundance of HBD-3 mRNA in Non-Lesional Skin for Non-Atopic Dermatitis (Non-AD) Participants Who Received Oral Vitamin D3 Versus Vitamin D3-Placebo | Baseline to Day 21 | Human Beta-defensin 3 (HBD-3) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = \[(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)\]. Non-AD is defined as a healthy volunteer without atopic dermatitis, therefore the lesional skin-type was not measured in this group. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. HBD-3 amount is clinically significant as it is necessary to resist infection. HBD-3 amount is not known to be clinically relevant to the clinical signs of dermatitis associated with AD. |
| Change From Baseline on Day 21 in Relative Abundance of CAMP mRNA in Lesional and Non-Lesional Skin for Atopic Dermatitis (AD) Participants Who Received Oral Vitamin D3 Versus Vitamin D3-Placebo | Baseline to Day 21 | Cathelicidin (CAMP) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = \[(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)\]. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. Cathelicidin amount is clinically significant as it is necessary to resist infection. Cathelicidin amount is not known to be clinically relevant to the clinical signs of dermatitis associated with AD. |
| Change From Baseline on Day 21 in Relative Abundance of CAMP mRNA in Non-Lesional Skin for Non-Atopic Dermatitis (Non-AD) Participants Who Received Oral Vitamin D3 Versus Vitamin D3-Placebo | Baseline to Day 21 | Cathelicidin (CAMP) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = \[(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)\]. Non-AD is defined as a healthy volunteer without atopic dermatitis, therefore the lesional skin-type was not measured in this group. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. Cathelicidin amount is clinically significant as it is necessary to resist infection. Cathelicidin amount is not known to be clinically relevant to the clinical signs of dermatitis associated with AD. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline on Day 21 in Relative Abundance of IL-13 mRNA in Non-Lesional Skin for Non-Atopic Dermatitis (Non-AD) Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo | Baseline to Day 21 | Cytokine interleukin-13 ( IL-13) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = \[(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)\]. Non-AD is defined as a healthy volunteer without atopic dermatitis. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. A decrease in IL-13 may be clinically correlated with improvement of AD. |
| Change From Baseline on Day 21 in Relative Abundance of IL-13 mRNA in Lesional and Non-Lesional Skin for Psoriatic Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo | Baseline to Day 21 | Cytokine interleukin-13 ( IL-13) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = \[(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)\]. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. There is no known clinical correlation between IL-13 and psoriasis. |
| Change From Baseline on Day 21 in Relative Abundance of IL-13 mRNA in Lesional and Non-Lesional Skin for Atopic Dermatitis (AD) Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo | Baseline to Day 21 | Cytokine interleukin-13 (IL-13) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = \[(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)\]. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. A decrease in IL-13 may be clinically correlated with improvement of AD. |
Countries
United States
Participant flow
Recruitment details
From January 2009 to November 2009, three centers in the United States recruited participants 18 to 70 years of age who fulfilled eligibility criteria. Refer to the Eligibility section for more details.
Participants by arm
| Arm | Count |
|---|---|
| Vitamin D (Non-AD) Healthy Volunteer participants who did not have atopic dermatitis (Non-AD) and received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 international units \[IU\] daily). | 16 |
| Vitamin D (AD) Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily). | 16 |
| Vitamin D (Psoriasis) Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily). | 8 |
| Placebo (Non-AD) Healthy Volunteer participants who did not have AD (Non-AD) and received a 21-day course of oral vitamin D3-placebo. | 16 |
| Placebo (AD) Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3- placebo. | 18 |
| Placebo (Psoriasis) Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3-placebo. | 8 |
| Total | 82 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 1 | 0 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 | 0 | 2 | 0 |
Baseline characteristics
| Characteristic | Vitamin D (AD) | Total | Placebo (Psoriasis) | Vitamin D (Non-AD) | Placebo (AD) | Placebo (Non-AD) | Vitamin D (Psoriasis) |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 32.2 years STANDARD_DEVIATION 10.5 | 32.5 years STANDARD_DEVIATION 10.9 | 37.1 years STANDARD_DEVIATION 11.4 | 31.4 years STANDARD_DEVIATION 12.3 | 28.6 years STANDARD_DEVIATION 9.8 | 32.2 years STANDARD_DEVIATION 8.9 | 40.5 years STANDARD_DEVIATION 11.6 |
| Body Mass Index (BMI; kg/m^2) | 25.2 kg/m^2 STANDARD_DEVIATION 4.7 | 25.3 kg/m^2 STANDARD_DEVIATION 4.9 | 27.1 kg/m^2 STANDARD_DEVIATION 4.6 | 24.6 kg/m^2 STANDARD_DEVIATION 5.5 | 24.9 kg/m^2 STANDARD_DEVIATION 3.5 | 24.5 kg/m^2 STANDARD_DEVIATION 5 | 28 kg/m^2 STANDARD_DEVIATION 6.9 |
| Fitzpatrick Skin Scale Extremely Fair Skin | 1 Participants | 3 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Fitzpatrick Skin Scale Fair Skin | 2 Participants | 20 Participants | 2 Participants | 4 Participants | 3 Participants | 5 Participants | 4 Participants |
| Fitzpatrick Skin Scale Markedly Black Skin | 1 Participants | 6 Participants | 0 Participants | 2 Participants | 1 Participants | 2 Participants | 0 Participants |
| Fitzpatrick Skin Scale Medium Skin | 5 Participants | 26 Participants | 4 Participants | 4 Participants | 7 Participants | 4 Participants | 2 Participants |
| Fitzpatrick Skin Scale Moderately Brown Skin | 0 Participants | 4 Participants | 1 Participants | 0 Participants | 3 Participants | 0 Participants | 0 Participants |
| Fitzpatrick Skin Scale Olive Skin | 7 Participants | 22 Participants | 1 Participants | 5 Participants | 2 Participants | 5 Participants | 2 Participants |
| Fitzpatrick Skin Scale Unknown | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 4 Participants | 10 Participants | 2 Participants | 0 Participants | 2 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Black | 1 Participants | 9 Participants | 0 Participants | 2 Participants | 4 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 1 Participants | 9 Participants | 1 Participants | 4 Participants | 0 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 15 Participants | 73 Participants | 7 Participants | 12 Participants | 18 Participants | 14 Participants | 7 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 9 Participants | 1 Participants | 2 Participants | 1 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 9 Participants | 54 Participants | 5 Participants | 12 Participants | 11 Participants | 11 Participants | 6 Participants |
| Region of Enrollment United States | 16 participants | 82 participants | 8 participants | 16 participants | 18 participants | 16 participants | 8 participants |
| Serum Calcium (mg/dL) | 9.4 mg/dL STANDARD_DEVIATION 0.4 | 9.4 mg/dL STANDARD_DEVIATION 0.4 | 9.2 mg/dL STANDARD_DEVIATION 0.3 | 9.3 mg/dL STANDARD_DEVIATION 0.3 | 9.5 mg/dL STANDARD_DEVIATION 0.3 | 9.3 mg/dL STANDARD_DEVIATION 0.4 | 9.4 mg/dL STANDARD_DEVIATION 0.4 |
| Serum Creatinine (mg/dL) | 0.8 mg/dL STANDARD_DEVIATION 0.1 | 0.8 mg/dL STANDARD_DEVIATION 0.2 | 0.8 mg/dL STANDARD_DEVIATION 0.1 | 0.8 mg/dL STANDARD_DEVIATION 0.1 | 0.8 mg/dL STANDARD_DEVIATION 0.2 | 0.8 mg/dL STANDARD_DEVIATION 0.2 | 0.8 mg/dL STANDARD_DEVIATION 0.2 |
| Serum Parathyroid Hormone (pg/mL) | 37.8 pg/mL STANDARD_DEVIATION 13.7 | 34.4 pg/mL STANDARD_DEVIATION 11.4 | 35.6 pg/mL STANDARD_DEVIATION 12.6 | 37.2 pg/mL STANDARD_DEVIATION 11.8 | 34.2 pg/mL STANDARD_DEVIATION 8.6 | 31.4 pg/mL STANDARD_DEVIATION 11.8 | 27.6 pg/mL STANDARD_DEVIATION 7.2 |
| Serum Vitamin D 25-Hydroxy (ng/mL) | 27.9 ng/mL STANDARD_DEVIATION 9.7 | 29.2 ng/mL STANDARD_DEVIATION 11.2 | 28.3 ng/mL STANDARD_DEVIATION 10.7 | 28.8 ng/mL STANDARD_DEVIATION 13.9 | 29.3 ng/mL STANDARD_DEVIATION 12.2 | 30.4 ng/mL STANDARD_DEVIATION 11.2 | 31.3 ng/mL STANDARD_DEVIATION 8.5 |
| Sex: Female, Male Female | 11 Participants | 44 Participants | 4 Participants | 9 Participants | 7 Participants | 9 Participants | 4 Participants |
| Sex: Female, Male Male | 5 Participants | 38 Participants | 4 Participants | 7 Participants | 11 Participants | 7 Participants | 4 Participants |
| Total Serum Immunoglobulin E (IgE) | 1870.1 kU/L STANDARD_DEVIATION 3310.5 | 553.3 kU/L STANDARD_DEVIATION 1825.2 | 69.7 kU/L STANDARD_DEVIATION 109 | 68.4 kU/L STANDARD_DEVIATION 127.3 | 724.9 kU/L STANDARD_DEVIATION 2030.6 | 45.7 kU/L STANDARD_DEVIATION 58.8 | 85.1 kU/L STANDARD_DEVIATION 82 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 16 | 0 / 16 | 0 / 8 | 0 / 16 | 0 / 18 | 0 / 8 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 | 0 / 8 | 0 / 16 | 0 / 18 | 0 / 8 |
Outcome results
Primary
Change From Baseline on Day 21 in Relative Abundance of CAMP mRNA in Lesional and Non-Lesional Skin for Atopic Dermatitis (AD) Participants Who Received Oral Vitamin D3 Versus Vitamin D3-Placebo
Cathelicidin (CAMP) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = \[(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)\]. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. Cathelicidin amount is clinically significant as it is necessary to resist infection. Cathelicidin amount is not known to be clinically relevant to the clinical signs of dermatitis associated with AD.
Time frame: Baseline to Day 21
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vitamin D (AD) | Change From Baseline on Day 21 in Relative Abundance of CAMP mRNA in Lesional and Non-Lesional Skin for Atopic Dermatitis (AD) Participants Who Received Oral Vitamin D3 Versus Vitamin D3-Placebo | Lesional Skin Type | -0.4 Cycle Number | Standard Deviation 2.8 |
| Vitamin D (AD) | Change From Baseline on Day 21 in Relative Abundance of CAMP mRNA in Lesional and Non-Lesional Skin for Atopic Dermatitis (AD) Participants Who Received Oral Vitamin D3 Versus Vitamin D3-Placebo | Non-Lesional Skin Type | -0.6 Cycle Number | Standard Deviation 2 |
| Placebo (AD) | Change From Baseline on Day 21 in Relative Abundance of CAMP mRNA in Lesional and Non-Lesional Skin for Atopic Dermatitis (AD) Participants Who Received Oral Vitamin D3 Versus Vitamin D3-Placebo | Lesional Skin Type | 0.1 Cycle Number | Standard Deviation 2.4 |
| Placebo (AD) | Change From Baseline on Day 21 in Relative Abundance of CAMP mRNA in Lesional and Non-Lesional Skin for Atopic Dermatitis (AD) Participants Who Received Oral Vitamin D3 Versus Vitamin D3-Placebo | Non-Lesional Skin Type | 0.7 Cycle Number | Standard Deviation 2.5 |
Comparison: Testing whether the change in CAMP expression in lesional skin of AD participants differs by treatment group.p-value: 0.7ANOVA
Comparison: Testing whether the change in CAMP mRNA expression in non-lesional skin of AD participants differs by treatment group.p-value: 0.12ANOVA
Primary
Change From Baseline on Day 21 in Relative Abundance of CAMP mRNA in Lesional and Non-Lesional Skin for Psoriatic Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo
Cathelicidin (CAMP) messenger ribonucleic acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = \[(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)\]. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline, Cathelicidin abundance in psoriasis has been hypothesized to correlate with increased inflammation. No direct clinical correlation is known.
Time frame: Baseline to Day 21
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vitamin D (AD) | Change From Baseline on Day 21 in Relative Abundance of CAMP mRNA in Lesional and Non-Lesional Skin for Psoriatic Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo | Lesional Skin Type | -0.9 Cycle Number | Standard Deviation 3 |
| Vitamin D (AD) | Change From Baseline on Day 21 in Relative Abundance of CAMP mRNA in Lesional and Non-Lesional Skin for Psoriatic Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo | Non-Lesional Skin Type | -0.6 Cycle Number | Standard Deviation 2.3 |
| Placebo (AD) | Change From Baseline on Day 21 in Relative Abundance of CAMP mRNA in Lesional and Non-Lesional Skin for Psoriatic Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo | Lesional Skin Type | 0.2 Cycle Number | Standard Deviation 3.2 |
| Placebo (AD) | Change From Baseline on Day 21 in Relative Abundance of CAMP mRNA in Lesional and Non-Lesional Skin for Psoriatic Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo | Non-Lesional Skin Type | 0.7 Cycle Number | Standard Deviation 2.4 |
Comparison: Testing whether change in CAMP mRNA expression in lesional skin of psoriatic participants differs by treatment group.p-value: 0.4ANOVA
Comparison: Testing whether change in CAMP mRNA expression in non-lesional skin of psoriatic participants differs by treatment group.p-value: 0.2ANOVA
Primary
Change From Baseline on Day 21 in Relative Abundance of CAMP mRNA in Non-Lesional Skin for Non-Atopic Dermatitis (Non-AD) Participants Who Received Oral Vitamin D3 Versus Vitamin D3-Placebo
Cathelicidin (CAMP) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = \[(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)\]. Non-AD is defined as a healthy volunteer without atopic dermatitis, therefore the lesional skin-type was not measured in this group. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. Cathelicidin amount is clinically significant as it is necessary to resist infection. Cathelicidin amount is not known to be clinically relevant to the clinical signs of dermatitis associated with AD.
Time frame: Baseline to Day 21
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vitamin D (AD) | Change From Baseline on Day 21 in Relative Abundance of CAMP mRNA in Non-Lesional Skin for Non-Atopic Dermatitis (Non-AD) Participants Who Received Oral Vitamin D3 Versus Vitamin D3-Placebo | 1.2 Cycle Number | Standard Deviation 2.4 |
| Placebo (AD) | Change From Baseline on Day 21 in Relative Abundance of CAMP mRNA in Non-Lesional Skin for Non-Atopic Dermatitis (Non-AD) Participants Who Received Oral Vitamin D3 Versus Vitamin D3-Placebo | 0.3 Cycle Number | Standard Deviation 1.7 |
Comparison: Testing whether the change in CAMP mRNA expression in non-lesional skin of Non-AD participants differs by treatment group.p-value: 0.3ANOVA
Primary
Change From Baseline on Day 21 in Relative Abundance of HBD-3 mRNA in Lesional and Non-Lesional Skin for Atopic Dermatitis (AD) Participants Who Received Oral Vitamin D3 Versus Vitamin D3-Placebo
Human Beta-defensin 3 (HBD-3) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies as measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = \[(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)\]. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. HBD-3 amount is clinically significant as it is necessary to resist infection. HBD-3 amount is not known to be clinically relevant to the clinical signs of dermatitis associated with AD.
Time frame: Baseline to Day 21
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vitamin D (AD) | Change From Baseline on Day 21 in Relative Abundance of HBD-3 mRNA in Lesional and Non-Lesional Skin for Atopic Dermatitis (AD) Participants Who Received Oral Vitamin D3 Versus Vitamin D3-Placebo | Lesional Skin Type | -0.1 Cycle Number | Standard Deviation 7.3 |
| Vitamin D (AD) | Change From Baseline on Day 21 in Relative Abundance of HBD-3 mRNA in Lesional and Non-Lesional Skin for Atopic Dermatitis (AD) Participants Who Received Oral Vitamin D3 Versus Vitamin D3-Placebo | Non-Lesional Skin Type | -0.1 Cycle Number | Standard Deviation 3.5 |
| Placebo (AD) | Change From Baseline on Day 21 in Relative Abundance of HBD-3 mRNA in Lesional and Non-Lesional Skin for Atopic Dermatitis (AD) Participants Who Received Oral Vitamin D3 Versus Vitamin D3-Placebo | Lesional Skin Type | -0.8 Cycle Number | Standard Deviation 2.8 |
| Placebo (AD) | Change From Baseline on Day 21 in Relative Abundance of HBD-3 mRNA in Lesional and Non-Lesional Skin for Atopic Dermatitis (AD) Participants Who Received Oral Vitamin D3 Versus Vitamin D3-Placebo | Non-Lesional Skin Type | 1.4 Cycle Number | Standard Deviation 3.9 |
Comparison: Testing whether change in HBD-3 mRNA expression in lesional skin of AD participants differs by treatment group.p-value: 0.8ANOVA
Comparison: Testing whether change in HBD-3 mRNA expression in non-lesional skin of AD participants differs by treatment group.p-value: 0.2ANOVA
Primary
Change From Baseline on Day 21 in Relative Abundance of HBD-3 mRNA in Lesional and Non-Lesional Skin for Psoriatic Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo
Human Beta-defensin 3 (HBD-3) Messenger Ribonucleic acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = \[(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)\]. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. There is no known clinical correlation between HBD-3 and psoriasis.
Time frame: Baseline to Day 21
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vitamin D (AD) | Change From Baseline on Day 21 in Relative Abundance of HBD-3 mRNA in Lesional and Non-Lesional Skin for Psoriatic Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo | Lesional Skin Type | 0.8 Cycle Number | Standard Deviation 5.3 |
| Vitamin D (AD) | Change From Baseline on Day 21 in Relative Abundance of HBD-3 mRNA in Lesional and Non-Lesional Skin for Psoriatic Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo | Non-Lesional Skin Type | -1.5 Cycle Number | Standard Deviation 3.2 |
| Placebo (AD) | Change From Baseline on Day 21 in Relative Abundance of HBD-3 mRNA in Lesional and Non-Lesional Skin for Psoriatic Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo | Lesional Skin Type | -1.6 Cycle Number | Standard Deviation 4.4 |
| Placebo (AD) | Change From Baseline on Day 21 in Relative Abundance of HBD-3 mRNA in Lesional and Non-Lesional Skin for Psoriatic Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo | Non-Lesional Skin Type | -1.5 Cycle Number | Standard Deviation 4.3 |
Comparison: Testing whether change in HBD-3 mRNA expression in lesional skin of psoriatic participants differs by treatment group.p-value: 0.4ANOVA
Comparison: Testing whether change in HBD-3 mRNA expression in non-lesional skin of psoriatic participants differs by treatment group.p-value: 1ANOVA
Primary
Change From Baseline on Day 21 in Relative Abundance of HBD-3 mRNA in Non-Lesional Skin for Non-Atopic Dermatitis (Non-AD) Participants Who Received Oral Vitamin D3 Versus Vitamin D3-Placebo
Human Beta-defensin 3 (HBD-3) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = \[(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)\]. Non-AD is defined as a healthy volunteer without atopic dermatitis, therefore the lesional skin-type was not measured in this group. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. HBD-3 amount is clinically significant as it is necessary to resist infection. HBD-3 amount is not known to be clinically relevant to the clinical signs of dermatitis associated with AD.
Time frame: Baseline to Day 21
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vitamin D (AD) | Change From Baseline on Day 21 in Relative Abundance of HBD-3 mRNA in Non-Lesional Skin for Non-Atopic Dermatitis (Non-AD) Participants Who Received Oral Vitamin D3 Versus Vitamin D3-Placebo | 0.2 Cycle Number | Standard Deviation 2.8 |
| Placebo (AD) | Change From Baseline on Day 21 in Relative Abundance of HBD-3 mRNA in Non-Lesional Skin for Non-Atopic Dermatitis (Non-AD) Participants Who Received Oral Vitamin D3 Versus Vitamin D3-Placebo | 1.2 Cycle Number | Standard Deviation 3.2 |
Comparison: Testing whether change in HBD-3 mRNA expression in non-lesional skin of Non-AD participants differs by treatment group.p-value: 0.4ANOVA
Secondary
Change From Baseline on Day 21 in Relative Abundance of IL-13 mRNA in Lesional and Non-Lesional Skin for Atopic Dermatitis (AD) Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo
Cytokine interleukin-13 (IL-13) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = \[(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)\]. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. A decrease in IL-13 may be clinically correlated with improvement of AD.
Time frame: Baseline to Day 21
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vitamin D (AD) | Change From Baseline on Day 21 in Relative Abundance of IL-13 mRNA in Lesional and Non-Lesional Skin for Atopic Dermatitis (AD) Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo | Lesional Skin Type | -0.7 Cycle Number | Standard Deviation 2.8 |
| Vitamin D (AD) | Change From Baseline on Day 21 in Relative Abundance of IL-13 mRNA in Lesional and Non-Lesional Skin for Atopic Dermatitis (AD) Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo | Non-Lesional Skin Type | -0.8 Cycle Number | Standard Deviation 2.3 |
| Placebo (AD) | Change From Baseline on Day 21 in Relative Abundance of IL-13 mRNA in Lesional and Non-Lesional Skin for Atopic Dermatitis (AD) Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo | Lesional Skin Type | 1.1 Cycle Number | Standard Deviation 2.7 |
| Placebo (AD) | Change From Baseline on Day 21 in Relative Abundance of IL-13 mRNA in Lesional and Non-Lesional Skin for Atopic Dermatitis (AD) Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo | Non-Lesional Skin Type | -0.1 Cycle Number | Standard Deviation 3.2 |
Comparison: Testing whether change in IL-13 mRNA expression in lesional skin of AD participants differs by treatment group.p-value: 0.2ANOVA
Comparison: Testing whether change in IL-13 mRNA expression in non-lesional skin of AD participants differs by treatment group.p-value: 0.5ANOVA
Secondary
Change From Baseline on Day 21 in Relative Abundance of IL-13 mRNA in Lesional and Non-Lesional Skin for Psoriatic Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo
Cytokine interleukin-13 ( IL-13) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = \[(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)\]. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. There is no known clinical correlation between IL-13 and psoriasis.
Time frame: Baseline to Day 21
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vitamin D (AD) | Change From Baseline on Day 21 in Relative Abundance of IL-13 mRNA in Lesional and Non-Lesional Skin for Psoriatic Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo | Lesional Skin Type | -2.1 Cycle Number | Standard Deviation 4.6 |
| Vitamin D (AD) | Change From Baseline on Day 21 in Relative Abundance of IL-13 mRNA in Lesional and Non-Lesional Skin for Psoriatic Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo | Non-Lesional Skin Type | -0.3 Cycle Number | Standard Deviation 2.7 |
| Placebo (AD) | Change From Baseline on Day 21 in Relative Abundance of IL-13 mRNA in Lesional and Non-Lesional Skin for Psoriatic Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo | Lesional Skin Type | -0.1 Cycle Number | Standard Deviation 4.1 |
| Placebo (AD) | Change From Baseline on Day 21 in Relative Abundance of IL-13 mRNA in Lesional and Non-Lesional Skin for Psoriatic Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo | Non-Lesional Skin Type | 0.9 Cycle Number | Standard Deviation 3.3 |
Comparison: Testing whether change in IL-13 mRNA expression in lesional skin of psoriatic participants differs by treatment group.p-value: 0.2ANOVA
Comparison: Testing whether change in IL-13 mRNA expression in non-lesional skin of psoriatic participants differs by treatment group.p-value: 0.3ANOVA
Secondary
Change From Baseline on Day 21 in Relative Abundance of IL-13 mRNA in Non-Lesional Skin for Non-Atopic Dermatitis (Non-AD) Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo
Cytokine interleukin-13 ( IL-13) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = \[(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)\]. Non-AD is defined as a healthy volunteer without atopic dermatitis. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. A decrease in IL-13 may be clinically correlated with improvement of AD.
Time frame: Baseline to Day 21
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vitamin D (AD) | Change From Baseline on Day 21 in Relative Abundance of IL-13 mRNA in Non-Lesional Skin for Non-Atopic Dermatitis (Non-AD) Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo | 0.2 Cycle Number | Standard Deviation 2.4 |
| Placebo (AD) | Change From Baseline on Day 21 in Relative Abundance of IL-13 mRNA in Non-Lesional Skin for Non-Atopic Dermatitis (Non-AD) Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo | 0.5 Cycle Number | Standard Deviation 1.5 |
Comparison: Testing whether change in IL-13 mRNA expression in non-lesional skin of Non-AD participants differs by treatment group.p-value: 0.7ANOVA