An Immuno-Dermatological disease registry to understand the burden of Atopic dermatitis (AD), Alopecia areata (AA), and Vitiligo in Indian Patients

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

Non-interventional study

• Non-interventional study design:
  Cohort

  Cross-sectional

  Other
• Non-interventional study design, other:
  Prospective longitudinal study

Study drug and medical condition

• Medical condition to be studied:
  Dermatitis atopic

  Alopecia areata

  Vitiligo

Population studied

• Age groups:
  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)
• Estimated number of subjects:
  3000

Study design details

• Main study objective:
  The objective of this study is to evaluate the epidemiological burden of mild, moderate and severe atopic dermatitis, vitiligo, and alopecia areata across enrolled dermatology centers.
• Outcomes:
  To evaluate the epidemiological burden of mild, moderate and severe atopic dermatitis, vitiligo and alopecia areata in patients across dermatology centers in India. ; Explain the current diagnostic criteria and grading modalities for AD, vitiligo and AA, to understand the burden of disease with a demographic overview Better understand the treatment for the diseases: topical, advanced therapies, surgical interventions and cosmetic procedures, the Unmet needs in diagnosis and management of dermatological disorders. Focus on patients’ perspectives on benefits.
• Data analysis plan:
  Descriptive statistics will be presented to describe patient characteristics. ; Categorical covariates will be described by frequency distribution while continuous covariates expressed in terms of their mean and standard deviation or median and interquartile range (IQR) as appropriate. ; The bivariate analysis will be conducted to determine if there is any association between the outcome and the exposure (the covariates). ; Unadjusted comparisons between groups of covariates and outcomes will be evaluated using appropriate tests: Pearson’s chi-square test will used for dichotomous categorical variables, t-test will be used for continuous variables, and the Mann-Whitney U test for non-parametric variables, p-values will be generated and 5% level of significance will be considered. ; In case of multiple testing or stepdown procedure either Tukey HSD or Bonferroni adjustment to p-value will be applied.

Documents

Study, other information

B7451103 Non Interventional Study Protocol Abstract V2.0_19 April 2023_Redacted

B7451103 Protocol Abstract 30 September 2022_Redacted

B7451103_NIS Protocol Abstract V3.0_Clean Copy_23DEC2024_Redacted.pdf