Epiduo Gel

Epiduo Gel

CLINICAL PHARMACOLOGY

Mechanism of Action

Adapalene

Adapalene binds to specific retinoic acid nuclear receptors but does not bind to cytosolic receptor protein. Biochemical and pharmacological profile studies have demonstrated that adapalene is a modulator of cellular differentiation, keratinization and inflammatory processes. However, the significance of these findings with regard to the mechanism of action of adapalene for the treatment of acne is unknown.

Benzoyl peroxide

Benzoyl peroxide is an oxidizing agent with bactericidal and keratolytic effects.

Pharmacodynamics

Pharmacodynamics of EPIDUO gel is unknown.

Pharmacokinetics

A pharmacokinetic study was conducted in 10 adult subjects with acne vulgaris who were treated once daily for 30 days with 2 grams/day of EPIDUO gel applied to 1000 cm² of acne involved skin, (face, chest, and upper back). Two subjects (20%) had quantifiable adapalene plasma concentrations above the limit of quantification (LOQ = 0.1ng/mL). The highest adapalene Cmax and AUC0-24h was 0.21 ng/mL and 1.99 ng•h/mL, respectively. Excretion of adapalene appears to be primarily by the biliary route. Pharmacokinetics of EPIDUO gel in pediatric subjects have not been evaluated. Benzoyl peroxide is absorbed by the skin where it is converted to benzoic acid and eliminated in the urine.

Clinical Studies

The safety and efficacy of EPIDUO gel applied once daily for the treatment of acne vulgaris were assessed in two 12week, multicenter, controlled clinical studies of similar design, comparing EPIDUO gel 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 EPIDUO gel, 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 EPIDUO gel, 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 EPIDUO gel 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 EPIDUO Gel at Week 12

  Study 1
EPIDUO gel
(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
  EPIDUO gel
(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
EPIDUO Gel
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%

Last reviewed on RxList: 2/26/2013
This monograph has been modified to include the generic and brand name in many instances.

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