NCT00877409

Safety and Efficacy Study of Acnase Creme in the Treatment of Acne Vulgaris I and II

A Monocentric, Single-Blind, Randomized, Placebo-Controlled Study of the Safety and Efficacy of the Topical Drug Acnase Creme in the Treatment of Acne Vulgaris I and II

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Zurita Laboratorio Farmaceutico Ltda. · Industry
• Sex: All
• Age: 12 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to establish the safety in use of the topical drug Acnase Creme and its effectiveness in treatment of acne grade I (comedones) and II (comedones, papules, pustules).

Detailed description

The acne is a common dermatosis in dermatological practice, affects more than 80% of the population during the second and third decades of life. It is found worldwide, with no evidence of racial or ethnic differences that influence the susceptibility to its development. However there is influence of genetic factors, hormones, the use of certain drugs that may have previous or aggravate the disease. It is an inflammatory disease of the follicle polissebáceo, which consists of large sebaceous glands, multiacinares, rudimentary hair follicle and a channel comprising a acro-infundibulum in its upper portion and an infra-infundibulum in the dermal portion. This is a benign condition, self-limited, but can cause serious psychological problems or disfiguring scars, which can persist for the rest of life. The initial change is a disorder of follicular epithelial differentiation, during which the cornea cells (keratinocytes) which are the follicle polissebáceo are excessively released in the lumen. The result of this event is the appearance of the precursor, microcomedão, from which the lesions of acne are developed (closed comedones, open comedones, papules, pustules and nodules). The dilation of the follicular infundibulum with the material produces a corneal comedão closed. This is the first clinically visible lesions of acne. As hyperkeratosis extends to the upper infundibulum, extended its opening, it formed the comedão open. The pathogenesis of acne is complex and understood only in part. The follicular occlusion with adherent keratinocytes and activation of hormone secretion resulting in the formation of sebaceous microcomedão. Studies suggest that free fatty acids intrafoliculares control inflammation through chemotactic properties on leukocytes, monocytes and neutrophils. The free fatty acids may provide the primary stimulus for the retention hyperkeratosis follicularis. Moreover, tallow provides a favorable substrate for the proliferation of Propiniobacterium acnes (P. acnes). Studies suggest that P. acnes, a microaerophilic bacterium (almost anaerobic), Gram-positive, has a lipase able to hydrolyze triglycerides in sebum into free fatty acids. Therefore, these pathogens play critical role in the generation of inflammatory lesions. The P. acnes produces proteases and neuroaminidases, which may increase the permeability of the follicular epithelium. Also produce a chemotactic factor of low molecular weight that selects the polymorphonuclear leukocytes. In the process of phagocytosis of bacteria are released hydrolases, which break the integrity of the follicular wall. Subsequently, the content intrafolicular - fragments of keratin, fat, hair, and P. acnes - is expelled to the dermis. If surface aggregation of neutrophils, as was a wheal, and with the presence of purulent secretion, a pustule. With the infiltration of inflammation deep and extensive, a nodule or cyst is produced. Clinically, the eruption acnéica is located predominantly in the face (90%) and to a lesser extent, in the back (60%) and chest (15%). As young man, mainly affects the face, while in older, the back.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	Benzoyl Peroxide 5% and Sulphur 2%	The product will be applied topically forming a thin layer, 1 time a day (at night) throughout the area affected by lesions.
DRUG	Vehicle of Acnase	The product will be applied topically forming a thin layer, 1 time a day (at night) throughout the area affected by lesions.

Timeline

• Start date: 2009-04-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2009-04-07
• Last updated: 2009-04-07

Locations

1 site across 1 country: Brazil