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Report for Clinical Trial NCT03831646

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Clinical, Psychological and Genetic Characteristics of Patients With Atopic Dermatitis and Psoriasis

Atopic dermatitis (AD) and psoriasis (PS) are chronic, relapsing dermatological disorders with a high rate of psychiatric co-morbid pathology represented with depression. Brain Derived Neurotrophic Factor (BDNF) belongs to the neurotrophin family and widely studied in pathophysiology of psychiatric and dermatological disorders. A biological stress response system by altered hypothalamic-pituitary-adrenal (HPA) axis as well hypothalamic-pituitary-gonadal (HPG) axis may contribute to dermatoses and psychiatric disorders development. Various factors including gender, genetic, psychological stress, socioeconomic factors also affect the course of dermatoses. A 10-week, case-control study evaluate clinical, psychological and biochemical parameters in AD and PS patients, and healthy control volunteers (HC) depending on gender and BDNF rs6265 gene polymorphism. All parameters are evaluated twice: at disease exacerbation (study baseline) and week 10. The following methods are conducted: assessment of dermatological status, using Scoring of Atopic Dermatitis (SCORAD) and Psoriasis Area and Severity Index (PASI); assessment of depression and anxiety according to DSM-V criteria and with Hamilton Depression Rating Scale (HAM-D) and with Hamilton Anxiety Rating Scale (HAM-A); analysis of serum BDNF (ng/ml), cortisol (nmol/L), testosterone (ng/dL) and IgE levels (IU/ml, AD only); DNA extraction and genotyping of BDNF variants.The study will last during 4-5 months.

NCT03831646 Atopic Dermatitis Psoriasis
MeSH: Dermatitis, Atopic Psoriasis Dermatitis Eczema
HPO: Atopic dermatitis Eczema Eczematoid dermatitis Inflammatory abnormality of the skin Palmoplantar pustulosis Psoriasiform dermatitis


Primary Outcomes

Description: Assessment of atopic dermatitis severity is conducted using Scoring of Atopic Dermatitis (SCORAD) index. SCORAD index formula is: A/5 + 7B/2 + C. In this formula A is defined as the extent (0-100), B is defined as the intensity (0-18) and C is defined as the subjective symptoms (0-20). The maximum SCORAD score is 103. SCORAD <23 - mild AD; SCORAD from 23 to 63 - moderate AD; SCORAD> 63 - severe AD.

Measure: Assessment of change in the severity of atopic dermatitis after conventional treatment from study onset (baseline) at week 10

Time: At disease onset (study baseline) and at week 10

Description: Assessment of the psoriasis severity is conducted using Psoriasis Area and Severity Index (PASI). The patient's body is divided into four sections (head (H) (10% of a person's skin); arms (A) (20%); trunk (T) (30%); legs (L) (40%)). The percent of skin lesions of each area is assessed as follows: 0 (0% of involved area); 1 (< 10%); 2 (10-29%); 3 (30-49%); 4 (50-69%); 5 (70-89%); 6 (90-100%). Further, for each region, the intensity of 3 clinical signs is evaluated - redness, thickness and scaling and assessed as follows: 0 - no lesions,1 - easy, 2 - moderate, 3 - severe, 4 - very severe. The sum of all three severity parameters is calculated for each section, multiplied by the area score for that area and multiplied by weight of respective section (0.1 for head, 0.2 for arms, 0.3 for body, 0.4 for legs). PASI range is from 0 (no disease) to 72 (maximum disease). The severity of psoriasis is assessed as follows: PASI <20 - mild; PASI from 20 to 50 - moderate; PASI> 50 - severe

Measure: Assessment of change in the severity of psoriasis after conventional treatment from study onset (baseline) at week 10

Time: At disease onset (study baseline) and at week 10

Description: Depression is assessed according to Diagnostic and Statistical Manual of Mental Disorders (DSM) -V criteria and with Hamilton Depression Rating Scale (HAM-D) using the following ranges: absence, ≤7; mild, 8-16; moderate, 17-27; severe, ≤28

Measure: Assessment of change in the severity of depression in atopic dermatitis and psoriasis patients after conventional treatment from study onset (baseline) at week 10

Time: At disease onset (study baseline) and week 10

Description: Depression is assessed according to Diagnostic and Statistical Manual of Mental Disorders (DSM) -V criteria and with Hamilton Depression Rating Scale (HAM-D) using the following ranges: absence, ≤7; mild, 8-16; moderate, 17-27; severe, ≤28

Measure: Assessment of the severity of depression in healthy controls (HC)

Time: At disease onset (study baseline)

Description: Anxiety is assessed according to Diagnostic and Statistical Manual of Mental Disorders (DSM) -V criteria and with Hamilton Anxiety Rating Scale (HAM-A) using the following ranges: ≤17, easy; 18-24, moderate; over 25, medium-severe

Measure: Assessment of change in the severity of anxiety in atopic dermatitis and psoriasis patients after conventional treatment from study onset (baseline) at week 10

Time: At disease onset (study baseline) and week 10

Description: Anxiety is assessed according to Diagnostic and Statistical Manual of Mental Disorders (DSM) -V criteria and with Hamilton Anxiety Rating Scale (HAM-A) using the following ranges: ≤17, easy; 18-24, moderate; over 25, medium-severe

Measure: Assessment of the severity of anxiety in HC

Time: At disease onset (study baseline)

Description: The total IgE levels are detected using solid-phase, chemiluminescent immunometric assay in an Immulite/Immulite 1000 (Siemens, Germany). Normal ranges are as follow: 0.000-100.0 IU/ml

Measure: Evaluation of changes in serum immunoglobulin E (IgE, IU/ml) levels from study onset (baseline) at week 10 in atopic dermatitis patients

Time: At disease onset (study baseline) and week 10

Description: The total IgE levels are detected using solid-phase, chemiluminescent immunometric assay in an Immulite/Immulite 1000 (Siemens, Germany). Normal ranges are as follow: 0.000-100.0 IU/ml

Measure: Analysis of serum IgE (IU/ml) levels in HC

Time: At disease onset (study baseline)

Description: Serum BDNF levels are analyzed using a solid-phase, sandwich, two-site, ELISA (Promega, US; G7610). No measurement scale is used

Measure: Evaluation of changes in serum Brain Derived Neurotrophic Factor (BDNF, ng/ml) levels from study onset (baseline) at week 10 in atopic dermatitis and psoriasis patients

Time: At disease onset (study baseline) and week 10

Description: Serum BDNF levels are analyzed using a solid-phase, sandwich, two-site, ELISA (Promega, US; G7610). No measurement scale is used

Measure: Analysis of serum BDNF (ng/ml) levels in HC

Time: At disease onset (study baseline)

Description: The total cortisol levels are detected using solid-phase, chemiluminescent immunometric assay in an Immulite/Immulite 1000 (Siemens, Germany). Normal ranges are as follow: 138-690 nmol/L

Measure: Evaluation of changes in cortisol (nmol/L) levels from study onset (baseline) at week 10 in atopic dermatitis and psoriasis patients

Time: At disease onset (study baseline) and week 10

Description: The total cortisol levels are detected using solid-phase, chemiluminescent immunometric assay in an Immulite/Immulite 1000 (Siemens, Germany). Normal ranges are as follow: 138-690 nmol/L

Measure: Analysis of serum cortisol (nmol/L) levels in HC

Time: At disease onset (study baseline)

Description: The total testosterone levels are detected using solid-phase, chemiluminescent immunometric assay in an Immulite/Immulite 1000 (Siemens, Germany). Normal ranges are as follow: men 20-49 years - 72 -853ng/dL; men≥50 years -129-767 ng/dL; women ovulating - 0.010-73.0 ng/dL; women postmenopausal - 0.010-43.0 ng/dL.

Measure: Evaluation of changes in testosterone (ng/dL) levels from study onset (baseline) at week 10 in atopic dermatitis and psoriasis patients

Time: At disease onset (study baseline) and week 10

Description: The total testosterone levels are detected using solid-phase, chemiluminescent immunometric assay in an Immulite/Immulite 1000 (Siemens, Germany). Normal ranges are as follow: men 20-49 years - 72 -853ng/dL; men≥50 years -129-767 ng/dL; women ovulating - 0.010-73.0 ng/dL; women postmenopausal - 0.010-43.0 ng/dL.

Measure: Analysis of serum testosterone (ng/dL) levels in HC

Time: At disease onset (study baseline)

Description: DNA extraction and genotyping the BDNF rs6265 (Val66Met) gene polymorphism in AD, PS and HC

Measure: DNA extraction in AD, PS and HC

Time: At disease onset (study baseline)

Secondary Outcomes

Description: EAD and IAD patients will be divided into subgroups in accordance with BDNF gene polymorphism and gender with following assessment of SCORAD scores compared with baseline after conventional treatment at week 10 in each group using unpaired t-test

Measure: Assessment and comparison (Unpaired t-test) of SCORAD scores in extrinsic atopic dermatitis (EAD, IgE level above the normal) and intrinsic atopic dermatitis (IAD, normal IgE level) patients compared with baseline after conventional treatment at week 10

Time: At disease onset (study baseline) and week 10

Description: Psoriasis patients will be divided into subgroups in accordance with BDNF gene polymorphism and gender with following assessment of PASI scores compared with baseline after conventional treatment at week 10 in each group.

Measure: Assessment and comparison (Unpaired t-test) of PASI scores in psoriasis patients compared with baseline after conventional treatment at week 10 in accordance with BDNF gene polymorphism (Val/Val; Val/Met;Met/Met) and gender(males, females)

Time: At disease onset (study baseline) and week 10

Description: Unpaired, two-way ANOVA and Bonferroni means separation tests will be used for multiple comparisons of HAM-D scores in EAD, IAD and PS patients and HC divided into subgroups in accordance with BDNF gene polymorphism and gender at disease onset (baseline) and week 10. Comparisons will include assessment of HAM-D scores in all patients at baseline and week 10 compared with HC, and assessment of data changes at week 10 compared with baseline

Measure: Unpaired, two-way ANOVA and Bonferroni means separation tests for multiple comparisons of HAM-D scores in EAD, IAD, PS and HC

Time: At disease onset (study baseline) and week 10

Description: Unpaired, two-way ANOVA and Bonferroni means separation tests will be used for multiple comparisons of HAM-A scores in EAD, IAD and PS patients and HC divided into subgroups in accordance with BDNF gene polymorphism and gender at disease onset (baseline) and week 10. Comparisons will include assessment of HAM-A scores in all patients at baseline and week 10 compared with HC, and assessment of data changes at week 10 compared with baseline

Measure: Unpaired, two-way ANOVA and Bonferroni means separation tests for multiple comparisons of HAM-A scores in EAD, IAD,PS and HC

Time: At disease onset (study baseline) and week 10

Description: Unpaired, two-way ANOVA and Bonferroni means separation tests will be used for multiple comparisons of serum BDNF(ng/ml) levels in EAD, IAD and PS patients and HC divided into subgroups in accordance with BDNF gene polymorphism and gender at disease onset (baseline) and week 10. Comparisons will include assessment of serum BDNF levels in all patients at baseline and week 10 compared with HC, and assessment of data changes at week 10 compared with baseline

Measure: Unpaired, two-way ANOVA and Bonferroni means separation tests for multiple comparisons of serum BDNF (ng/ml) levels in EAD, IAD,PS and HC

Time: At disease onset (study baseline) and at week 10

Description: Unpaired, two-way ANOVA and Bonferroni means separation tests will be used for comparisons of serum cortisol (nmol/L) levels in EAD, IAD and PS patients and HC divided into subgroups in accordance with BDNF gene polymorphism and gender at disease onset (baseline) and week 10. Comparisons will include assessment of serum cortisol levels in all patients at baseline and week 10 compared with HC, and assessment of data changes at week 10 compared with baseline

Measure: Unpaired, two-way ANOVA and Bonferroni means separation tests for multiple comparisons of serum cortisol (nmol/L) levels in EAD, IAD,PS and HC

Time: At disease onset (study baseline) and at week 10

Description: Unpaired, two-way ANOVA and Bonferroni means separation tests will be used for multiple comparisons of serum testosterone (ng/dL) levels in EAD, IAD and PS patients and HC divided into subgroups in accordance with BDNF gene polymorphism and gender at disease onset (baseline) and week 10. Comparisons will include assessment of serum testosterone levels in all patients at baseline and week 10 compared with HC, and assessment of data changes at week 10 compared with baseline

Measure: Unpaired, two-way ANOVA and Bonferroni means separation tests for multiple comparisons of serum testosterone (ng/dL) levels in EAD, IAD,PS and HC

Time: At disease onset (study baseline) and at week 10

Description: Assessment of testosterone/cortisol ratio in EAD, IAD, PS patients and HC divided into BDNF rs6265 gene polymorphism (Val/Val; Val/Met; Met/Met) and gender (males, females) at study baseline and week 10

Measure: Assessment of testosterone/cortisol ratio in EAD, IAD, PS patients and HC in accordance with BDNF rs6265 gene polymorphism and gender

Time: At disease onset (study baseline) and at week 10

Description: Unpaired, two-way ANOVA and Bonferroni means separation tests will be used for multiple comparisons of testosterone/cortisol ratio in EAD, IAD and PS patients and HC divided into subgroups in accordance with BDNF gene polymorphism and gender at disease onset (baseline) and week 10. Comparisons will include assessment of testosterone/cortisol ratio in all patients at baseline and week 10 compared with HC, and assessment of data changes at week 10 compared with baseline

Measure: Unpaired, two-way ANOVA and Bonferroni means separation tests for multiple comparisons of testosterone/cortisol ratio in EAD, IAD, PS and HC

Time: At disease onset (study baseline) and at week 10

Description: Correlation analysis of dermatological, psychological and biochemical parameters in EAD, IAD and PS patients, and HC divided into groups in accordance with BDNF rs6265 gene polymorphism (Val/Val; Val/Met; Met/Met) and gender (males, femaes)

Measure: Correlation analysis of studied parameters in dermatological patients and HC

Time: At disease onset (study baseline) and week 10

Time Perspective: Prospective

Case-Control


There is one SNP

SNPs


1 rs6265

A 10-week, case-control study evaluate clinical, psychological and biochemical parameters in AD and PS patients, and healthy control volunteers (HC) depending on gender and BDNF rs6265 gene polymorphism.

DNA extraction and genotyping the BDNF rs6265 (Val66Met) gene polymorphism in AD, PS and HC.

Assessment of testosterone/cortisol ratio in EAD, IAD, PS patients and HC in accordance with BDNF rs6265 gene polymorphism and gender.

Assessment of testosterone/cortisol ratio in EAD, IAD, PS patients and HC divided into BDNF rs6265 gene polymorphism (Val/Val; Val/Met; Met/Met) and gender (males, females) at study baseline and week 10.

Correlation analysis of dermatological, psychological and biochemical parameters in EAD, IAD and PS patients, and HC divided into groups in accordance with BDNF rs6265 gene polymorphism (Val/Val; Val/Met; Met/Met) and gender (males, femaes).

This study evaluate clinical, psychological and biochemical parameters in AD and PS patients depending on gender and BDNF rs6265 gene polymorphism.



HPO Nodes


HPO:
Atopic dermatitis
Genes 9
DOCK8 IFIH1 HSPA9 DOCK8 ZNF341 PGM3 CARD11 NEK9 BRAF
Eczema
Genes 150
COL5A2 TGM5 GTF2H5 SLC30A2 DDX41 CYBB HPGD FECH ERCC2 MSN GNA11 CYBA MYSM1 NCF1 HLA-DRB1 RBM8A KDF1 MPLKIP TARS1 CASR MCCC2 NCF1 SMARCC2 FOXP3 STAT3 GINS1 RNU4ATAC TAF1 WIPF1 IL7 HDAC4 RTTN TNFRSF1B TP63 LBR FLG DHCR7 EFL1 FECH SHOC2 KRT1 TBX1 GP1BB RBCK1 WIPF1 NSUN2 CTLA4 CARMIL2 TRPM1 CARD14 WAS C5 CIB1 CASP8 DOCK8 FLI1 AUTS2 NCF2 RNF113A HPGD ERCC3 WAS RAC1 CARD11 SUOX HLA-DQB1 STAT1 SBDS FOXP3 ZNF750 MS4A2 TRAF6 TBX1 NCF2 CYBB WAS STAT1 COL1A1 CYBC1 PCCB IL2RA PAH IFIH1 HPGD SPINK5 HIRA SLCO2A1 NEK9 BRAF TMC8 BTD IL4R CD3G PAH EDARADD MTHFD1 CYBA CSTA PGM3 NCF4 BTD KRT16 EDA EDAR DNAJC21 DOCK8 ZNF341 SMARCA2 RREB1 RNU4ATAC SIK3 GTF2E2 IL7R PIGA SRD5A3 HSPA9 HLCS COL5A1 PIK3CA PTPRC SRP54 ZAP70 LIG4 NSUN2 NSMCE3 CD28 PGM3 ARVCF TMC6 SEC24C NCF4 DNAJC21 KRT9 CTLA4 SMARCA2 STAT3 POLE FLI1 PCCA PLA2G7 JMJD1C TRAF3IP2 MBTPS2 RAC1 TBX1 COMT UFD1 NOD2 KANSL1 STAT3
Eczematoid dermatitis
Genes 11
HPGD ZAP70 NCF1 HPGD CYBA FLG FOXP3 SLCO2A1 STAT3 CYBB NCF2
Inflammatory abnormality of the skin
Genes 454
TGM5 GTF2H5 TGM1 IL17RA MSN FERMT3 CTSC MBTPS2 ERCC2 BTK NFKB1 SPINK5 ERCC4 B2M TP63 KRT5 CASP10 NLRP3 MCCC2 LMBRD1 LYZ STAT3 GINS1 RFX5 KIT HYOU1 TP63 FLG DHCR7 TGFB1 KRT1 PEPD MBTPS2 TRPM1 WAS KDSR CIB1 ENPP1 PSTPIP1 SH3PXD2B HPGD NOD2 ALOX12B CERS3 TNFAIP3 ZNF750 RFXAP MS4A2 TBX1 CACNA1G IFIH1 SPINK5 SLC6A19 ERCC5 HIRA WNT4 SLCO2A1 BRAF WNT4 CD3G EDARADD CYBA CSTA DOCK8 SMARCA2 HLCS CARD14 KRT17 CIITA HLA-DPB1 KIF11 MEFV AP1B1 IL10 COL5A1 PTPRC DNASE1 NSUN2 IL12A-AS1 PAPSS2 ARVCF KRT5 RAG2 SEC24C SMARCAD1 FCGR2A IL2RG DNAJC21 CD28 AIP PNPLA1 SPTB FLI1 CD3E PLA2G7 ELANE SULT2B1 CHST14 JMJD1C TCF3 SLC29A3 COMT AGA SDR9C7 CLEC7A STAT3 ADAM17 CD247 SPTA1 TNFRSF1A KRT1 GJB6 BCL11B BLNK MEIS2 FAM111B NLRP3 MYSM1 GJB2 HLA-DRB1 IRF2BP2 LAMB3 CD79B KDF1 MPLKIP ABCA12 CASR POMP NCF1 NCSTN CYP4F22 SRP54 RNU4ATAC IL1RN MNX1 EFL1 FECH SHOC2 MIF C1R GP1BB POLR3A WIPF1 CARMIL2 CTSC TTC7A JAK3 DOCK8 FLI1 KRT14 NLRP12 SPP1 CTLA4 GJB3 IL7R GJB2 USP8 SUOX FOXC2 FOXP3 GATA3 CYBB LHCGR COL1A1 DCLRE1C PSMB4 PTPN22 KIT SP110 BTNL2 TMC8 BTK CCBE1 CTSB GJA1 PRKACA PGM3 EDAR LPIN2 RREB1 PEPD RNU4ATAC GPR101 GTF2E2 H6PD PIGA C1QA KRT10 KLRC4 CFI BTK HLA-B PDGFRA APOA1 ZAP70 LIG4 ADAMTS3 EPB42 TMC6 ERCC2 ELANE BTNL2 KIT SDHA STAT3 IL17F ADA DSG1 PRTN3 NFE2L2 KRT1 COX4I2 NOD2 RMRP FGA ANK1 ALOXE3 COL7A1 COL5A2 NFKB2 DDX41 HPGD CCR1 ERCC2 AK2 LACC1 HSD3B2 LIG4 IL17RA TARS1 TCIRG1 SH3PXD2B SMARCC2 WIPF1 RFXANK IL7 LMBRD1 MSMO1 TNFRSF1B LBR FGFR2 IL17RC TBX1 PTPN22 RBCK1 IL17F STAT4 ABCA12 GJC2 C5 ABCA12 GJB4 AUTS2 HLA-DRB1 AP1S3 CCBE1 GFI1 EPG5 RNF113A TEK POR ERCC3 NAXD RFXANK GATA1 CARD11 HLA-DQB1 GJC2 FLT4 SBDS LYST TTC7A STAT1 CYBC1 PCCB HLA-DPA1 RIPK1 HPGD RAG2 BTD CLEC7A PAH NR3C1 BTD KRT16 DNAJC21 IL10RA CIITA ADA EXTL3 ZNF341 SIK3 TNFRSF1A PSENEN IL7R MYD88 SRD5A3 HLCS LBR IGHM TRAF3IP2 LIG4 NSMCE3 GTF2H5 KRT10 ESR1 PGM3 CYP4F22 IL12A PSMB8 TNFRSF1B IL23R RFX5 NIPAL4 DNASE1L3 IL10RB IL6 EGFR KRT9 CTLA4 SLC39A4 LIPN ECM1 POLE TRAF3IP2 HLA-B MBTPS2 RAC1 SHANK3 XYLT1 ZAP70 UFD1 KANSL1 FAT4 NIPAL4 CARD9 TGM1 ACADVL SLC30A2 CYBB PSEN1 FECH GNA11 ALOXE3 CYBA TREX1 RAG1 PSMB9 NCF1 AIRE RBM8A SDHC LPIN2 RAG1 TFRC NLRC4 FOXP3 KRT10 ERAP1 TAF1 ITGA6 SDHB LYST HDAC4 RTTN CD3D VEGFC CTLA4 DCLRE1C LRRC8A NSUN2 CTLA4 IL7R NOD2 CARD14 IL2RG CASP8 FCGR2B RAG1 MPDU1 IGLL1 PSTPIP1 NCF2 KRT1 PNPLA1 ERCC3 WAS RAC1 CTLA4 CD79A SLC4A1 CDK10 STAT1 RBP4 FAS AIRE KDF1 TRAF6 NCF2 ITGB4 WAS IL2RA PAH HLA-DRB1 TLR4 MBL2 STAT4 NEK9 LAMA3 IL4R MVK MTHFD1 ADA2 GLUL LAMC2 NCF4 XIAP PIK3R1 EDA CHD7 ALOX12B IL36RN CDH23 UBE2A STING1 HSPA9 UBAC2 PIK3CA SRP54 ESR1 C4A CD28 RAG2 IRAK1 RFXAP ABCC6 NIPAL4 NCF4 IL2RG UROS SMARCA2 MEFV TGM1 FERMT1 PCCA MVK EBP TBX1 TGM1 GJB2 HLA-C IKBKG NFKB2 DCLRE1C
Palmoplantar pustulosis
Psoriasiform dermatitis
Genes 22
NFKB2 LIG4 DSG1 CARD14 FOXP3 CTLA4 SLC29A3 HLA-B IL36RN HLA-DQB1 MSMO1 TTC7A GATA3 HLA-DRB1 TTC7A FLI1 CACNA1G HLA-C AP1S3 IRF2BP2 TP63 NFKB2