Comparison of clindamycin/benzoyl peroxide, tretinoin plus clindamycin, and the combination of clindamycin/benzoyl peroxide and tretinoin plus clindamycin in the treatment of acne vulgaris: a randomized, blinded study

Journal of Drugs in Dermatology, Sept-Oct, 2005 by Steven Bowman, Michael Gold, Adnan Nasir, George Vamvakias

Table 1. Investigator's Global Evaluation Score.

Score  Description

0      Clear; no inflammatory lesions
0.5    Sparse comedones, with very few or no inflammatory lesions
       present
1.0    Comedones, with some small inflammatory lesions present; minimal
       erythema
1.5    Comedones, with an increasing number of inflammatory lesions
       compared to grade 1
2.0    Comedones, with a moderate number of small inflammatory lesions
       extending over a wide area of the face; increasing erythema
2.5    Comedones, with an increasing number of inflammatory lesions vs.
       grade 2.0, with some larger inflamed lesions
3.0    Numerous comedones, papules, and pustules with larger inflamed
       lesions extending over much of the face; erythema may be
       pronounced
3.5    Comedones, with profuse papulopustular lesions with numerous
       large inflammatory lesions; some deep pustular lesions may be
       present
4.0    Patient has severe or cystic (nodular) acne and is excluded from
       the study

Table 2. Demographic and Baseline Characteristics (ITT population,
N = 132).

                         Clin/BP                    Tret   Clin
Parameter                (n = 43)                   (n = 45)

Age (years)
  Mean (SD)              18.6 (5.4)                 18.8 (4.6)
  Range                  12-33                      12-30
Gender, n (%)
  Male                   19 (44)                    18 (40)
  Female                 24 (56)                    27 (60)
Race, n (%)
  White                  33 (77)                    35 (78)
  African American        8 (19)                     8 (18)
  Native American         1 (2)                      1 (2)
  Other                   1 (2)                      1 (2)
Facial comedones*
  Mean (SD)              59.3 (59.7)                74.8 (67.0)[dagger]
  Range                  20-341                     21-299
Pustules*
  Mean (SD)               4.7 (7.7)[double dagger]   5.9 (5.7)
  Range                   0-43                       0-24
Papules*
  Mean (SD)              26.2 (9.8)                 29.1 (7.5)
  Range                  13-52                      19-54
Investigator's Global
Acne Severity Score*
  Mean (SD)               2.1 (0.5)                  2.2 (0.5)
  Range                   1.5-3                      1.5-3

                          Clin/BP   Tret   Clin
Parameter                 (n = 44)

Age (years)
  Mean (SD)               19.3 (5.7)
  Range                   12-31
Gender, n (%)
  Male                    15 (34)
  Female                  29 (66)
Race, n (%)
  White                   32 (73)
  African American        12 (27)
  Native American          0
  Other                    0
Facial comedones*
  Mean (SD)               60.8 (55.8)
  Range                   20-264
Pustules*
  Mean (SD)                5.6 (5.1)
  Range                    0-18
Papules*
  Mean (SD)               25.9 (8.4)
  Range                   14-47
Investigator's Global
Acne Severity Score*
  Mean (SD)                2.1 (0.5)
  Range                    1.5-3

Clin/BP, clindamycin 1%/benzoyl peroxide 5% gel; SD, standard deviation;
Tret   Clin, tretinoin 0.025% gel plus clindamycin 1% gel.
*Clin/BP, n = 40; Tret   Clin, n = 43; Clin/BP   Tret   Clin, n = 42.
[dagger]P < .05 for Tret   Clin vs. Clin/BP and Clin/BP   Tret   Clin.
[double dagger]P < .05 for Clin/BP vs. Tret   Clin and Clin/BP   Tret  
Clin.

Table 3. Adverse Events Occurring in >5% of Patients in Any Treatment
Group (ITT population, N = 132).

                               Clin/BP   Tret   Clin
Adverse event, n (%)           (n = 43)  (n = 45)

Application Site Irritation    5 (11.6)  8 (17.8)
Application Site Dryness       3 (7.0)   7 (15.6)
Application Site Desquamation  3 (7.0)   5 (11.1)
Application Site Erythema      2 (4.7)   4 (8.9)
Sinusitis                      6 (14.0)  1 (2.2)
Application Site Pruritus      4 (9.3)   0
Nasopharyngitis                3 (7.0)   2 (4.4)

                               Clin/BP   Tret   Clin  Total
Adverse event, n (%)           (n = 44)               (N = 132)

Application Site Irritation    13 (30.0)              26 (19.7)
Application Site Dryness       12 (27.3)              22 (16.7)
Application Site Desquamation   6 (13.6)              14 (10.6)
Application Site Erythema       7 (15.9)              13 (9.9)
Sinusitis                       1 (2.3)                8 (6.1)
Application Site Pruritus       3 (6.8)                7 (5.3)
Nasopharyngitis                 1 (2.3)                6 (4.6)

Clin/BP, clindamycin 1%/benzoyl peroxide 5% gel; Tret   Clin, tretinoin
0.025% gel plus clindamycin 1% gel.