Adapalene and Benzoyl Peroxide (Page 3 of 5)

14 CLINICAL STUDIES

The safety and efficacy of adapalene and benzoyl peroxide gel, 0.1%/2.5% applied once daily for the treatment of acne vulgaris were assessed in two 12-week, multicenter, controlled clinical studies of similar design, comparing adapalene and benzoyl peroxide gel, 0.1%/2.5% to the gel vehicle in acne subjects. Treatment response was defined as the percent of subjects who had a two grade improvement and rated ‘Clear’ and ‘Almost Clear’ at Week 12 based on the Investigator’s Global Assessment (IGA) and mean absolute change from baseline at Week 12 in both inflammatory and non-inflammatory lesion counts.

An IGA score of ‘Clear’ corresponded to residual hyperpigmentation and erythema may be present. An IGA score of ‘Almost Clear’ corresponded to a few scattered comedones and a few small papules.

In Study 1, 517 subjects were randomized to adapalene and benzoyl peroxide gel, 0.1%/2.5%, adapalene 0.1% in vehicle gel, benzoyl peroxide 2.5% in vehicle gel, or vehicle gel. The median age of these 517 subjects was 15 years old and 60% were males.

At baseline subjects had between 20 to 50 inflammatory lesions and 30 to 100 non-inflammatory lesions. The majority of subjects had a baseline IGA score of ‘Moderate’ which corresponded to more than half of the face is involved, many comedones, papules and pustules. The efficacy results at week 12 are presented in Table 3.

In Study 2, 1668 subjects were randomized to adapalene and benzoyl peroxide gel, 0.1%/2.5%, adapalene 0.1% in vehicle gel, benzoyl peroxide 2.5% in vehicle gel, or vehicle gel. The median age of subjects was 16 years old and 49% were males. At baseline subjects had between 20 to 50 inflammatory lesions and 30 to 100 non-inflammatory lesions as well as an Investigator Global Assessment score of ‘Moderate’. The efficacy results at week 12 are presented in Table 3.

In Study 3, 285 pediatric subjects 9 to 11 years of age were randomized to adapalene and benzoyl peroxide gel, 0.1%/2.5% or vehicle gel. The median age of subjects was 11 years and 24% were males. At baseline, subjects had a minimum of 20 but not more than 100 total lesions (inflammatory and/or non-inflammatory) with an Investigator Global Assessment score of ‘Moderate’. The efficacy results at week 12 are presented in Table 3.

Table 3: Clinical Efficacy of Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% at Week 12

Study 1

Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% (N=149)

Adapalene 0.1% in Vehicle gel (N=148)

Benzoyl Peroxide 2.5% in Vehicle gel (N=149)

Vehicle gel (N=71)

IGA: Two Grade Improvement and Clear or Almost Clear

32

(21.5%)

18

(12.2%)

18

(12.1%)

4

(5.6%)

Inflammatory Lesions: Mean Absolute (Percent) Change

16.0

(52.4%)

11.4

(39.9%)

10.5

(35.8%)

9.5

(31.8%)

Non-inflammatory Lesions: Mean Absolute (Percent) Change

23.4

(45.9%)

15.2

(29.6%)

13.7

(32.2%)

13.2

(27.8%)

Study 2

Adapalene and Benzoyl Peroxide Gel, 0.1%/2/5% (N=415)

Adapalene 0.1% in Vehicle gel (N=420)

Benzoyl Peroxide 2.5% in Vehicle gel (N=415)

Vehicle gel (N=418)

IGA: Two Grade Improvement and Clear or Almost Clear

125

(30.1%)

83

(19.8%)

92

(22.2%)

47

(11.3%)

Inflammatory Lesions: Mean Absolute (Percent) Change

15.4

(53.4%)

12.3

(41.7%)

13.7

(47.6%)

8.7

(30.2%)

Non-inflammatory Lesions: Mean Absolute (Percent) Change

24.6

(48.1%)

21.0

(40.8%)

19.2

(37.2%)

11.3

(23.2%)

In both Studies 1 and 2 the treatment effect was smaller in subjects with a small number of baseline lesions than in subjects with a large number of baseline lesions.

Study 3

Adapalene and Benzoyl Peroxide Gel,0.1%/2.5%

(N=142)

Vehicle Gel

(N=143)

IGA: Two Grade Improvement and Clear or Almost Clear

67

(47.2%)

22

(15.4%)

Inflammatory Lesions: Mean Absolute (Percent) Change

7.4

(36.0%)

0.7

(-13.2%)*

Non-inflammatory Lesions: Mean Absolute (Percent) Change

20.2

(54.7%)

2.9

(2.3%)

*-That is, a mean percent increase of 13.2%

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