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Standardizing Outcome Measures in Alopecia Areata

Overview of assessment methods for alopecia areata including the SALT and ALODEX scoring systems, response criteria and potential global score.

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Standardizing Outcome Measures in Alopecia Areata

  1. 1. Standardizing Outcome Measures in Alopecia Areata Elise A. Olsen, MD Professor of Dermatology and Medicine Director, Hair Disorders Research and Treatment Center Duke University Medical Center
  2. 2. Thanks to my colleagues who worked on the following consensus document: Olsen EA, Roberts J, Sperling L, Tosti A, Shapiro J, McMichael A, Bergfeld W, Callender V, Mirmirani P, Washenik K, Whiting D, Cotsarelis G, Hordinsky M. Objective Outcome Measures: Collecting Meaningful Data on Alopecia Areata. J Am Acad Dermatol 2018
  3. 3. Alopecia Areata: Inherent Difficulties Posed for Clinical Trials • Unlike other hair disorders, alopecia areata: – Is constantly and unpredictably mutable – May spontaneously remit • General rule: 90% of those with patchy hair loss will have spontaneous regrowth within 2 years • Efalizumab study: 8% of patients with extensive (>50% hair loss) had spontaneous regrowth in a 3 month clinical trial • Longer time a patient experiences AT or AU, less likely to have spontaneous regrowth
  4. 4. Alopecia Areata: Inherent Difficulties Posed for Clinical Trials • Unlike other hair disorders, alopecia areata may have one or more prognostic factors that negatively impact on overall response. These prognostic factors include: • Extent of hair loss • Pattern of hair loss: AT, AU, ophiasis • Initial onset of AA • Duration of hair loss without regrowth • Nail abnormalities • Atopy
  5. 5. Alopecia Areata: Inherent Difficulties Posed for Clinical Trials • The presence of other hair disorders, especially pattern hair loss, is not uncommon with alopecia areata and can effect outcome – Patients may not have or declare a prior diagnosis of another hair disorder and it only becomes obvious during the clinical trial – May be aware of at baseline and question is whether to exclude patient or make concessions for lesser potential regrowth in those portions of scalp – African American patients may have follicular drop out secondary to CCCA or marginal alopecia—dermatoscopic exam or biopsy is highly recommended to insure no scarring process present
  6. 6. Alopecia Areata: Inherent Difficulties Posed for Clinical Trials • Unlike other hair disorders, patients with alopecia areata may not have any normal density to use as a comparator for 100% regrowth (the typical definition of “complete response”) • Complete “coverage” is the goal for most patients but the target hair density to achieve this and a quantifiable measure is ill defined • Location of the remaining hair loss is a key feature in patient satisfaction with treatment. It is not enough to have a SALT50 or SALT75if the remaining hair loss is not able to be concealed. But relying on patient satisfaction as a primary endpoint could fault an effective drug that is not leading to hair growth in key coverage areas
  7. 7. Alopecia Areata: Inherent Difficulties Posed for Clinical Trials • Unlike other hair disorders, alopecia areata can wax and wane over time with periods of active hair loss or persistent stable hair loss. Should inclusion criteria focus on those only with “active” hair loss? • Active hair loss: – Can be determined by either finding exclamation point hairs or a positive hair pull – Can be a two edged sword for clinical trials. Patients with active hair loss are: • more likely to have an active inflammatory lymphocytic infiltrate (target) around the lower follicle • more likely to have further hair loss during the initial part of a clinical study—”lose before they gain”
  8. 8. Severity Alopecia Tool (SALT) Score • The current accepted and reproducible method of assessing hair loss in alopecia areata • Utilizes the visual aid (SALT I) published in 2004 which divides the scalp into 4 quadrants with assigned percent scalp surface area in each area* • Can be used for clinical trials of both systemic and topical medications for alopecia areata • Easy to use, fast, and excellent reproducibility among investigators *Olsen EA, Hordinsky MK, Price VH, Roberts JL, Shapiro J, Canfield D et al.: Alopecia areata investigational assessment guidelines – Part II. J Am Acad Dermatol, 51: 440-447, 2004. .
  9. 9. SALT Score Utilizing SALT I Visual Aid With the SALT I, the percent scalp hair loss in each quadrant is determined by visually moving the remaining terminal hair together to what appears to be normal density and then determining what % of the bald scalp remains. Example*: Top (left side view) = 95% X 0.18 = 17.1% 2nd (right side view) = 90 % X 0.18 = 16.2% 3rd (top view of scalp) = 95% X 0.4 = 38% Bottom (back of scalp)=55% X 0.24 = 13.2% SALT score = 84.5% *Olsen EA. Investigative guidelines for alopecia areata. Dermatol Ther. 24(3):311-9, 2011.
  10. 10. SALT Score: Sequential Analysis Date Top: 40% Back: 24% Left Side:18% Rt. Side: 18% Total % of Hair Loss
  11. 11. Severity Alopecia Tool (SALT) Score Problems with determining the SALT score • For a given rater – Combines extent of hair loss and hair density into a single grade done simultaneously – Dependent on assuming normal density for a given patient – Visually superimposing the scalp quadrant defined by the figure onto a patient’ scalp when determining % hair loss for that quadrant – Requires consideration of potential overlap of scalp quadrants when assessing each quadrant • Between raters: Differences in each of the above become magnified
  12. 12. SALT Score Utilizing SALT I Visual Aid • Limitations of SALT score: – Reproducibility is related to same investigator doing all assessments – Does not allow tracking individual lesions or small changes in density – Does not allow separating out whether SALT score at follow-up visits involves new untreated bald areas or just areas of hair loss present since baseline. – Does not allow determination of percentage scalp involved with any hair loss, only bald scalp
  13. 13. Hair Density in Hair Disorders • Assessment of density in designated regions of the scalp was first reported in 2003 • Using pre and post treatment photographs and a figure with designations of the sections of the scalp relevant to MPHL ie F, M and V, hair density was assigned to each region. The density scale developed was based on dots representing a target area hair count with each specific density a sequential 50% decrease in follicular number from the prior one. The end result was reported as FxMxVx Olsen EA, Canfield D, Canfield W, Budris K: A novel method for assessing regional scalp hair density in male pattern hair loss. Hair Science and Technology, 251 – 254, 2003.
  14. 14. Alopecia Density and Extent (ALODEX) Score • ALODEX score is an alternate method of assessing hair loss • Utilizes: – New SALT II visual aid which breaks scalp up into 1% scalp surface areas – Assigns density rating in each area currently based on a 10 point scale of hair loss from 0= no hair loss to 10 = complete baldness (AT or AU) • ALODEX score = summation of all density ratings in each 1% scalp area *Olsen EA and Canfield D. SALT II: A New Take on the Severity of Alopecia Tool (SALT) for Determining Scalp Hair Loss. Accepted for Publication JAAD September 2016 SALT II Visual Aid*
  15. 15. Alopecia Density and Extent (ALODEX) Score • By assessing hair density in each of the 1% scalp areas, the use of this visual aid allows the following to be tracked: – The amount of absolute hair loss (ALODEX score) – Specific areas of baldness (all 1% areas are numbered) – Small changes in density that may otherwise go undetected with SALT score – Percentage of scalp surface involved with any hair loss and thus needing to be treated topically – New areas of hair loss present since baseline of any given treatment – Lesional scoring by identifying target areas
  16. 16. Select the segments you would like to grade Assign the applicable percent hair loss score The percent hair loss will be then be applied to the selected segments Electronic Capture of the ALODEX Score
  17. 17. Top View Score: 27%
  18. 18. Left Lateral View Score: 14%
  19. 19. Right Lateral View Score: 12%
  20. 20. Back View Score: 14%
  21. 21. Example of Grading for ALODEX Score Area x density in each scalp quadrant as follows: Top of scalp = 27% Back of scalp = 14% L side of scalp = 14% R side of scalp= 12% ALODEX score = 67%
  22. 22. ALODEX score Limitations of the ALODEX score • Shape of areas of hair loss may not match the 1% areas on the figure • More time consuming than SALT score to perform for patients with multiple areas of hair loss • Current density scale currently is a relative scale determined by the grader. A new density scale is being developed that should improve the reliability of this part of the scoring
  23. 23. Lesional Density Score (LAD) • Useful for target lesions being treated locally ( Ex. IL steroids) • Cannot be representative of AA in a single patient • The area of hair loss is calculated by the product of the longest bi-perpendicular measurements X the density score • If multiple areas of hair loss are being tracked together, then the LAD score is the sum of the individual LAD scores
  24. 24. Global Scoring • Should both patients and physicians be asked for their assessment of % hair regrowth at study end? Can patient overall assessment of percent change be compared with change in SALT score determined by investigator? • Consider a simple measure of degree of hair growth or hair loss based on magnitude of change from -3,-2, -1 (hair loss) to 0 (no change) to+1,+2 and +3 (regrowth)? Are patient’s and physician’s results likely to be concordant? • What quantifiable measure will be concordant with changes on a QoL assessment?
  25. 25. Conclusions • Clinical trials of alopecia areata provide different challenges than those of other hair disorders • Rather than exclude patients who have poor prognostic characteristics, it may be more reasonable to just insure appropriate stratification between treatment groups. • Lesional scoring (LAD) is useful primarily for intralesional treatments as no one area can be representative of the whole head • The SALT score is a relatively quick, reliable assessment measure of overall hair loss but does not identify new areas of hair loss or track response in areas of hair loss if less than full regrowth • The ALODEX score is more time consuming to perform but provides documentation of new lesions and incremental increases in hair density
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    Mar. 14, 2021
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    Mar. 13, 2021
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    Sep. 14, 2020
  • TomokoMaedaChubachi

    Sep. 14, 2020

Overview of assessment methods for alopecia areata including the SALT and ALODEX scoring systems, response criteria and potential global score.

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