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FDA Perspective on Global Evaluation of Facial Acne

FDA Perspective on Global Evaluation of Facial Acne. Brenda Carr, M.D. Medical Officer Division of Dermatologic and Dental Drug Products FDA. Outline. Challenges to scale design Benefits of a common scale Attributes of a scale Examples of scales. Challenges to Scale Design.

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FDA Perspective on Global Evaluation of Facial Acne

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  1. FDA Perspective on Global Evaluation of Facial Acne Brenda Carr, M.D. Medical Officer Division of Dermatologic and Dental Drug Products FDA

  2. Outline • Challenges to scale design • Benefits of a common scale • Attributes of a scale • Examples of scales

  3. Challenges to Scale Design • pleomorphic nature of acne • variability in lesions • variability in natural course • what to assess

  4. Benefits of a Standard Scale • Objective basis for treatment assessment • Assessment of disease status in clinical trials • Interpretation of trial results

  5. Attributes of a Scale • A limited number of levels • Levels which are sufficiently described • Levels which indicate the “clear” (no acne) and “almost clear” state • Static measures to reflect a point in time • A high degree of correlation with lesion counts

  6. Examples ofScales

  7. Example #1 (Leed’s) • Grade 0 (no acne) to Grade 10 (most severe acne) • Grades 0 to 2: subdivided by 0.25 increments; 9 grades • Grades 2 to 10: subdivided by 0.50 increments; 17 grades

  8. Example #2 (Cook’s) Grade 0: Need not be perfect; 3 small comedones and/or small papules if they are scattered Grade 2: Very few pustules or perhaps 3 dozen papules and/or comedones; no big or prominent lesions; lesions are hardly visible form 2.5 m away Grade 4: Between 2 and 6; red lesions and inflammation to a significant degree; worthy of treatment Grade 6: Loaded with comedones; no inflammation; or inflammatory lesions; must have numerous pustules; lesions are easily recognized at 2.5 m; some pustules may be quite large, 1 to 2 cm Grade 8: Conglobata, sinus, or cystic type acne; or a highly inflammatory acne covering most of the face; yellow pustules extend to neck and chin

  9. Example #3 0 = worse 1 = no change 2 = slight improvement 3 = moderate improvement 4 = excellent improvement

  10. Example #4 0 (None)= occasional comedones, but no evidence of acne requiring treatment 1 (Minimal) = non-inflammatory lesions predominate, several comedones and small papules/pustules, no inflamed nodulo-cystic lesions 2 (Mild) = non-inflammatory lesions predominate, multiple inflammatory lesions several to many comedones and small papules/pustules, perhaps 1 small evolving or involuting nodulo-cystic lesion 3 (Moderate) = inflammatory lesions are more apparent, many small papules/pustules, perhaps a few inflamed nodulo-cystic lesions 4 (Severe) = highly inflammatory lesions predominate, variable number of comedones several to many papules/pustules, several to many inflamed nodulo-cystic lesions

  11. Example #5 0 (Normal)= clear skin with no evidence of acne vulgaris 1 (Almost clear) = a few to several (up to 15) non-inflammatory lesions (comedones) are present; a few (up to 7) inflammatory (papules/pustules) may be present 2 (Minimal to Mild) = several to many (>15) non-inflammatory lesions (comedones) are present; a few to several (>7) papules/pustules are present; no nodulo-cystic lesions 3 (Moderate) = many (>20) non-inflammatory and inflammatory (>20) lesions are present, there may or may not be 1 small nodulo-cystic lesion 4 (Severe) = High degree of inflammatory disease; papules/pustules are a predominant feature, variable number of comedones may be present; there may or may not be a few nodulo-cystic lesions

  12. Example #6 0 = Normal, clear skin with no evidence of acne vulgaris 1 = Skin is almost clear: rare non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving and may be hyperpigmented, though not pink-red) 2 = Some non-inflammatory lesions are present, with few inflammatory lesions (papules/pustules only; no nodulo-cystic lesions) 3 = Non-inflammatory lesions predominate, with multiple inflammatory lesions evident: several to many comedones and papules/pustules, and there may or may not be one small nodulo-cystic lesion 4 = Inflammatory lesions are more apparent: many comedones and papules/pustules, there may or may not be a few nodulo-cystic lesions 5 = Highly inflammatory lesions predominate: variable number of comedones, many papules/pustules nodulo-cystic lesions

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