Acanya Gel
CLINICAL PHARMACOLOGY
Mechanisms of Action
Clindamycin
[See Microbiology].
Benzoyl Peroxide
Benzoyl peroxide is an oxidizing agent with bacteriocidal and keratolytic effects.
Pharmacokinetics
An in vivo bioavailability study has not been conducted with ACANYA Gel (clindamycin phosphate 1.2% and benzoyl peroxide 2.5%) . Benzoyl peroxide has been shown to be absorbed by the skin where it is converted to benzoic acid.
Microbiology
Clindamycin binds to the 50S ribosomal subunits of susceptible bacteria and prevents elongation of peptide chains by interfering with peptidyl transfer, thereby suppressing bacterial protein synthesis.
Clindamycin and benzoyl peroxide individually have been shown to have in vitro activity against Propionibacterium acnes, an organism which has been associated with acne vulgaris; however, the clinical significance of this activity against P. acnes is not known and was not examined in clinical trials with ACANYA Gel (clindamycin phosphate 1.2% and benzoyl peroxide 2.5%) .
P. acnes resistance to clindamycin has been documented. Resistance to clindamycin is often associated with resistance to erythromycin.
Clinical Studies
The safety and efficacy of once daily use of ACANYA Gel (clindamycin phosphate 1.2% and benzoyl peroxide 2.5%) were assessed in two 12-week multi-center, randomized, blinded studies in patients 12 years and older with moderate to severe acne vulgaris. The two studies were identical in design and compared ACANYA Gel (clindamycin phosphate 1.2% and benzoyl peroxide 2.5%) to clindamycin in the vehicle gel, benzoyl peroxide in the vehicle gel, and the vehicle gel alone. The co-primary efficacy variables were:
(1) Mean absolute change from baseline at week 12 in
- Inflammatory lesion counts
- Non-inflammatory lesion counts
(2) Percent of subjects who had a two grade improvement from baseline on an Evaluator's Global Severity (EGS) score.
The EGS scoring scale used in all of the clinical trials for ACANYA Gel (clindamycin phosphate 1.2% and benzoyl peroxide 2.5%) is as follows:
| Grade | Description |
| Clear | Normal, clear skin with no evidence of acne vulgaris |
| Almost Clear | Rare non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving and may be hyperpigmented, though not pink-red) |
| Mild | Some non-inflammatory lesions are present, with few inflammatory lesions (papules/pustules only; no nodulocystic lesions) |
| Moderate | 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 |
| Severe | Inflammatory lesions are more apparent, many comedones and papules/pustules, there may or may not be a few nodulocystic lesions |
| Very Severe | Highly inflammatory lesions predominate, variable number of comedones, many papules/pustules and many nodulocystic lesions |
The results of Study 1 at week 12 are presented in the table
below:
| ACANYA Gel | Clindamycin Gel | Benzoyl Peroxide Gel | Vehicle Gel | |
| Study 1 | N = 399 | N = 408 | N = 406 | N = 201 |
| EGSS Clear or Almost Clear | 115 (29%) | 84 (21%) | 76 (19%) | 29 (14%) |
| 2 grade reduction from baseline | 131 (33%) | 100 (25%) | 96 (24%) | 38 (19%) |
| Inflammatory Lesions: | ||||
| Mean absolute change | 14.8 | 12.2 | 13.0 | 9.0 |
| Mean percent (%) reduction | 55.0% | 47.1% | 49.3% | 34.5% |
| Non-Inflammatory Lesions: | ||||
| Mean absolute change | 22.1 | 17.9 | 20.6 | 13.2 |
| Mean percent (%) reduction | 45.3% | 38.0% | 40.2% | 28.6% |
The results of Study 2 at week 12 are presented in the table
below:
| ACANYA Gel | Clindamycin Gel | Benzoyl Peroxide Gel | Vehicle Gel | |
| Study 2 | N = 398 | N = 404 | N = 403 | N = 194 |
| EGSS Clear or Almost Clear | 113 (28%) | 94 (23%) | 94 (23%) | 21 (11%) |
| 2 grade reduction from baseline | 147 (37%) | 114 (28%) | 114 (28%) | 27 (14%) |
| Inflammatory Lesions: | ||||
| Mean absolute change | 13.7 | 11.3 | 11.2 | 5.7 |
| Mean percent (%) reduction | 54.2% | 45.3% | 45.7% | 23.3% |
| Non-Inflammatory Lesions: | ||||
| Mean absolute change | 19.0 | 14.9 | 15.2 | 8.3 |
| Mean percent (%) reduction | 41.2% | 34.3% | 34.5% | 19.2% |
Last reviewed on RxList: 7/20/2010
This monograph has been modified to include the generic and brand name in many instances.
Additional Acanya Gel Information
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