Ignite Creation Date:
2024-05-06 @ 12:44 PM
Last Modification Date:
2024-10-26 @ 1:03 PM
Study NCT ID:
NCT03831646
Status:
COMPLETED
Last Update Posted:
2019-08-20
First Post:
2019-01-30
Brief Title:
Clinical Psychological and Genetic Characteristics in Dermatological Patients
Sponsor:
Astana Medical University
Organization:
Astana Medical University
Study Overview
Official Title:
Clinical Psychological and Genetic Characteristics of Patients With Atopic Dermatitis and Psoriasis
Status:
COMPLETED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 ngml cortisol nmolL testosterone ngdL and IgE levels IUml AD only DNA extraction and genotyping of BDNF variantsThe study will last during 4-5 months
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 ngml cortisol nmolL testosterone ngdL and IgE levels IUml AD only DNA extraction and genotyping of BDNF variantsThe study will last during 4-5 months
Detailed Description:
Atopic dermatitis AD and psoriasis PS are related to psychodermatological disorders with chronic relapsing course multifactorial etiology and complex pathogenesis In accordance with DSM-V AD and PS belong to psychosomatic disorders with psychogenic manifestation and exacerbation whereas depression represents a high range of psychiatric co-morbid pathology in AD and PS patients Brain Derived Neurotrophic Factor BDNF is a prominent representative of the neurotrophins family widely studied in pathophysiology of psychiatric and dermatological disorders Various factors including ethnicity gender genetic and socioeconomic causes as well methods of diagnosis and case definition may affect the course of dermatoses A possible mechanism that contributes to dermatitis and psychiatric disorders development is dysregulation of the biological stress response system by altered hypothalamic-pituitary-adrenal HPA axis functioning In addition many studies emphasize the role of gonadal hormones both in depression and dermatoses
This study evaluate clinical psychological and biochemical parameters in AD and PS patients depending on gender and BDNF rs6265 gene polymorphism Investigators conduct a 10-week case-control study among AD and PS patients and healthy controls HC volunteers All parameters are evaluated twice at disease exacerbation study baseline and week 10
The following methods are used 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 Hamilton Anxiety Rating Scale HAM-A analysis of serum BDNF ngml cortisol nmolL testosterone ngdL and IgE levels IUml AD only DNA extraction and genotyping of BDNF variants
Sample collection and processing blood are taken between 8-10 am to prevent daily variations on week 0 and week 10 and collected to serum-separation tubes SST and EDTA tubes for DNA extraction samples are cooled 1 hr 4C and centrifuged 2000xg 10 minutes 25C serum are stored at -20C before analysis DNA extraction from whole blood is performed3 days from collection and stored -70C
After written informed consent and first blood sample patients are provided with conventional treatments For AD this include antihistamines eg diphenhydramine desloratadine topical corticosteroids eg betamethasone mometasone up to 3 weeks and emollients up to 2 months for PS we will prescribe antihistamines eg diphenhydramine desloratadine topical corticosteroids eg betamethasone mometasone up to 3 weeks and keratolytics 2 salicylic ointment up to 2 weeks Patients are not prescribed antidepressants and other psychotropic agents
For assessment of study parameters all patients and HC will be divided into subgroups according to gender males femaes and BDNF gene polymorphism ValVal ValMet MetMet Additionally AD patients will be divided by IgE sensitization EAD extrinsic IgE sensitive and IAD intrinsic IgE non-sensitive
The study will last for 4-5 months Patients inclusion criteria no pregnancy no unstable non-dermatological medical conditions no systemic therapy glucocorticosteroids immunosuppressants and psychotropic drugs within the month prior the study and blood sampling no history of mental or other dermatological disorders no severe forms of AD and PS good general physical health Inclusion criteria for HC are no pregnancy and good general physical health
Statistics will be performed using unpaired t-test or paired t-test week 0 week 10 comparisons verified by PearsonSpearman correlation Unpaired one-way ANOVA andor two-way ANOVA test will be used for multiple group comparisons Data will be presented as meanSEM
This study evaluate clinical psychological and biochemical parameters in AD and PS patients depending on gender and BDNF rs6265 gene polymorphism Investigators conduct a 10-week case-control study among AD and PS patients and healthy controls HC volunteers All parameters are evaluated twice at disease exacerbation study baseline and week 10
The following methods are used 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 Hamilton Anxiety Rating Scale HAM-A analysis of serum BDNF ngml cortisol nmolL testosterone ngdL and IgE levels IUml AD only DNA extraction and genotyping of BDNF variants
Sample collection and processing blood are taken between 8-10 am to prevent daily variations on week 0 and week 10 and collected to serum-separation tubes SST and EDTA tubes for DNA extraction samples are cooled 1 hr 4C and centrifuged 2000xg 10 minutes 25C serum are stored at -20C before analysis DNA extraction from whole blood is performed3 days from collection and stored -70C
After written informed consent and first blood sample patients are provided with conventional treatments For AD this include antihistamines eg diphenhydramine desloratadine topical corticosteroids eg betamethasone mometasone up to 3 weeks and emollients up to 2 months for PS we will prescribe antihistamines eg diphenhydramine desloratadine topical corticosteroids eg betamethasone mometasone up to 3 weeks and keratolytics 2 salicylic ointment up to 2 weeks Patients are not prescribed antidepressants and other psychotropic agents
For assessment of study parameters all patients and HC will be divided into subgroups according to gender males femaes and BDNF gene polymorphism ValVal ValMet MetMet Additionally AD patients will be divided by IgE sensitization EAD extrinsic IgE sensitive and IAD intrinsic IgE non-sensitive
The study will last for 4-5 months Patients inclusion criteria no pregnancy no unstable non-dermatological medical conditions no systemic therapy glucocorticosteroids immunosuppressants and psychotropic drugs within the month prior the study and blood sampling no history of mental or other dermatological disorders no severe forms of AD and PS good general physical health Inclusion criteria for HC are no pregnancy and good general physical health
Statistics will be performed using unpaired t-test or paired t-test week 0 week 10 comparisons verified by PearsonSpearman correlation Unpaired one-way ANOVA andor two-way ANOVA test will be used for multiple group comparisons Data will be presented as meanSEM
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None