Alopecia areata investigational assessment guidelines*

1.PURPOSE To establish criteria for selecting and assessing subjects for both clinical and laboratory studies of alopecia areata, thereby facilitating collaboration, comparison of data, and the sharing of patient-derived tissue 2.DEFINITION OF ALOPECIA AREATA Alopecia areata is a dermatologic disease characterized in its limited form by circumscribed round or oval patches of alopecia with well-demarcated borders between normal and affected scalp. There is no scale or induration of the scalp and no loss of follicular markings. Disease extent may progress from this limited form to complete loss of hair on the scalp and/or body. 3.INCLUSION CRITERIA These guidelines apply only to terminal hair loss or growth on the scalp. These guidelines focus on the major forms of alopecia areata (patchy alopecia areata, alopecia totalis, and alopecia universalis) and their expression on the scalp. The terms alopecia totalis and alopecia universalis imply 100% scalp hair loss. Areas of hair loss other than on the scalp may be assessed and documented in the data collected on each patient. (See Section IV B) 4.CRITERIA FOR MEASURING EXTENT OF INVOLVEMENT Those data items in boldface type should be filled out inThose data items not in bold are optional and can be filled out as desired by the investigator. 1.The proportion of scalp involvement is determined by dividing the scalp into 4 quadrants and estimating the percentage of the scalp surface that all the alopecic areas would occupy if placed together. The following groups will be used: •S: Scalp hair loss •___________S0= No hair loss •___________S1= ≤ 25% hair loss •___________S2= 26%-50% hair loss •___________S3= 51%-75% hair loss •___________S4= 76%-99% hair loss •___________a = 76%-95% hair loss •___________b = 96%-99% hair loss •___________S5 = 100% hair loss •Other areas of alopecia or involvement by alopecia areata may be noted: •B:Body hair loss •___________B0= No body hair loss •___________B1= Some body hair loss •___________B2= 100% body (excluding scalp) hair loss •N:Nail involvement •___________N0 = No nail involvement •___________N1 = Some nail involvement •___________a. Twenty-nail dystrophy/trachyonychia (must be all 20 nails) •Terminology •The term alopecia totalis is S5 B0 only and is 100% scalp terminal hair loss. •The term alopecia totalis/alopecia universalis (AT/AU) is S5 B0 -B2 and implies 100% scalp terminal hair loss with variable body hair loss. •The term alopecia universalis is S5 B2 and is 100% scalp terminal hair and 100% body hair loss. •ALOPECIA AREATA DATABASE 1.Essential background data •Patient’s initials__________ •Date of intake___________ •Age__________ •Date of birth__________ •Age at onset of first episode of alopecia areata__________ •First episode of alopecia areata (month/year of onset)__________ •Current episode alopecia areata •Age of onset__________ •Month/year of onset__________ •Duration of current episode (months)__________ •Extent of hair loss__________(S0 -S5 , B0 -B2 : as defined in IVA and IVB) •Sex •Male_____ •Female_____ •Racial group •American Indian or Alaskan native_____ •Asian or Pacific Islander_____ •Black, not of Hispanic origin_____ •Hispanic_____ •White, not of Hispanic origin_____ •Predominant hair color •Black_____ •Brown_____ •Red_____ •Blond_____ •Gray_____ •White_____ •Prior history of alopecia areata •Number of prior episodes of alopecia areata_____ •History of alopecia totalis or alopecia totalis/alopecia universalis at any time 1.> 2 years’ duration_____ 2.≤ 2 years’ duration_____ 3.Pertinent immediate past history •History of infections within 6 months before onset of hair loss 1.Initial episode of alopecia areata •Site of infection__________ •Type of infection__________ •Current episode of alopecia areata •Site of infection__________ •Type of infection__________ •History of vaccination within 6 months before onset of hair loss 1.Initial episode of alopecia areata •Type of vaccination__________ •Current episode of alopecia areata •Type of vaccination__________ •Patient’s or parent’s perception of trigger for hair loss •Initial episode__________ •Current episode__________ •Patient and family medical history