# Presentation: 261111

## FDA Perspective on Global Evaluation of Facial Acne

- Brenda Carr, M.D.
- Medical Officer
- Division of Dermatologic  and Dental Drug Products
- FDA

## Challenges to scale design 

Benefits of a common scale

Attributes of a scale 

Examples of scales

- Benefits of a common scale
- Attributes of a scale
- Examples of scales

- Outline

## Challenges to Scale Design

- pleomorphic nature of acne
- variability in lesions
- variability in natural course
- what to assess

## Benefits of a Standard Scale

- Objective basis for treatment assessment
- Assessment of disease status in clinical trials
- Interpretation of trial results

## 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

## Examples of  Scales

## 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

## 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

## Example #3

**0 =** worse
**1 =** no change
**2 =** slight improvement
**3 =** moderate improvement
**4 =** excellent improvement

## 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

## 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

## 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