Tazarotene cream versus adapalene cream in the treatment of facial acne vulgaris: a multicenter, double-blind, randomized, parallel-group study

Journal of Drugs in Dermatology, March-April, 2005 by A. Shalita, B. Miller, A. Menter, W. Abramovits, K. Loven, L. Kakita

Table 1. Grading Scales for Outcome Measures. (All evaluations were
investigator assessments except for overall acne severity which was
evaluated by patients.)

       Overall Global Response     Overall Disease         Overall Acne
Grade  to Treatment                Severity*               Severity

0      Completely cleared          None (clear; no         None
       (no signs of symptoms of    inflammatory lesions)
       disease)
1      Almost cleared (~90%        Sparse comedos, with    Minimal/trace
       improvement; very           very few or no
       significant clearance with  inflammatory lesions
       only traces of the disease  present
       remaining)
2      Marked improvement          Mild comedos, with      Mild
       (~75% improvement;          some small
       significant improvement     inflammatory lesions
       with some disease           present; minimal
       remaining)                  erythema
3      Moderate improvement        Comedos with an         Moderate
       (~50% improvement;          increasing number of
       intermediate between mild   inflammatory lesions
       and marked improvement)     compared to grade 2
4      Mild improvement (~25%      Moderate comedos, a     Severe
       improvement; some           moderate number of
       improvement but             small inflammatory
       significant disease         lesions extending over
       remains)                    a wide area of the
                                   face; erythema is
                                   increasing
5      No change                   Comedos, an increasing  Very Severe
                                   number of inflammatory
                                   lesions compared to
                                   grade 4, with some
                                   larger inflamed
                                   lesions
6      Exacerbation                Severe, numerous        --
       (worsening)                 comedos, papules, and
                                   pustules with larger
                                   inflamed lesions
                                   extending over much
                                   of the face; erythema
                                   may be pronounced

       Peeling, Erythema,
       Dryness, and Perception
Grade  of Oiliness              Burning

0      None (normal)            None (normal, no discomfort)
1      Trace                    Trace (an awareness but no discomfort
       (mild and localized)     and no intervention required)
2      Mild                     Mild (noticeable discomfort causing
       (mild and diffuse)       intermittent awareness)
3      Moderate                 Moderate (noticeable discomfort causing
       (moderate and diffuse)   continuous awareness)
4      Marked                   Marked (definite discomfort causing
       (moderate and dense)     continuous awareness that interferes
                                occasionally with normal daily
                                activities)
5      Severe                   Severe (definite, continuous discomfort
       (prominent and dense)    that interferes with normal daily
                                activities)
6      --                       --

* Photographic reprints representative of grades 1, 3, and 3 were
provided as a guide.

Table 2. Patient Characteristics at Baseline.

                             Tazarotene        Adapalene
                             (N=86)            (N=87)

Mean age [  or -] SD, y      21 [  or -] 7.2   19 [  or -] 7.1
Males, no. (%)               36 (42)           35 (40)
Caucasians, no. (%)          58 (67)           64 (74)
Skin type, no. (%)
  Oily                       16 (19)           12 (15)
  Normal/oily                31 (36)           38 (46)
  Normal                      7 (8)            12 (15)
  Normal/dry                 10 (12)            3 (4)
  Dry                         2 (2)             0 (0)
  Mixed oily/dry             20 (23            18 (22)
Papule   pustule count,
  mean [  or -] SD           16 [  or -] 7.3   18 [  or -] 9.7
Open   closed comedo count,
  mean [  or -] SD           43 [  or -] 24.5  45 [  or -] 23.5
Overall disease severity
  (investigator rating),
  no. (%)
  None                        0 (0)             0 (0)
  Sparse comedos              0 (0)             0 (0)
  Mild                        0 (0)             0 (0)
  Mild-to-moderate           49 (57)           40 (46)
  Moderate                   25 (29)           36 (41)
  Moderate-to-severe         12 (14)           11 (13)
  Severe                      0 (0)             0 (0)
Overall acne severity
  (patient ratings),
  no. (%)
  None                        0 (0)             0 (0)
  Trace                       2 (2)             1 (1)
  Mild                       26 (30)           29 (35)
  Moderate                   47 (55)           40 (49)
  Severe                     11 (13)           10 (12)
  Very Severe                 0 (0)             2 (2)

                             P Value for Between-Group
                             Difference

Mean age [  or -] SD, y      .256
Males, no. (%)               .898
Caucasians, no. (%)          .474
Skin type, no. (%)           .497
  Oily
  Normal/oily
  Normal
  Normal/dry
  Dry
  Mixed oily/dry
Papule   pustule count,
  mean [  or -] SD           .041
Open   closed comedo count,
  mean [  or -] SD           .500
Overall disease severity
  (investigator rating),
  no. (%)                    .370
  None
  Sparse comedos
  Mild
  Mild-to-moderate
  Moderate
  Moderate-to-severe
  Severe
Overall acne severity
  (patient ratings),
  no. (%)                    .904
  None
  Trace
  Mild
  Moderate
  Severe
  Very Severe

Figure 1

                                              Patients (%)
                                Tazarotene 0.1%        Adapalene 0.1%
                                cream                  cream

P [less than or equal to] .01
[greater than or equal to] 50%
  global improvement            77%                    55%

P [less than or equal to] .01
[greater than or equal to] 75%
  global improvement            55%                    34%

Note: Table made from bar graph.

Figure 3

                                           Patients (%)
P [less than or equal to] .01  Tazarotene 0.1%        Adapalene 0.1%
between groups overall         cream                  cream

None                                  4%                     1%
Trace                                28%                    15%
Mild                                 45%                    45%
Moderate                             18%                    30%
Severe                                5%                     9%
Very severe                           0%                     0%

Note: Table made from bar graph.