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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Zurita Laboratorio Farmaceutico Ltda..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Zurita Laboratorio Farmaceutico Ltda.
ClinicalTrials.gov Identifier:
NCT00877409
First received: April 6, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
  Purpose

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).


Condition Intervention Phase
Acne Vulgaris
Drug: Benzoyl Peroxide 5% and Sulphur 2%
Drug: Vehicle of Acnase
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Zurita Laboratorio Farmaceutico Ltda.:

Primary Outcome Measures:
  • Average clinical development of target lesions of the groups for each experimental time. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical evolution of the acne through the counting of inflammatory and non - inflammatory lesions. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Evaluation of oily skin through the clinical evaluation with four-point scale (absent, mild, moderate, intense) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Observation of occurrence and intensity of clinical parameters erythema, scaling, itching and burning through the clinical evaluation with four-point scale (absent, mild, moderate, severe). [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: April 2009
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Acnase 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.
Other Name: Acnase
Placebo Comparator: Vehicle 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.
Other Names:
  • Control
  • Vehicle
  • Placebo

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.

  Eligibility

Ages Eligible for Study:   12 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age: 12 to 35 years;
  • Oily skin with tendency to acne;
  • Presence of non-inflammatory lesions and inflammatory, acne vulgaris diagnosed as grade I or II, as the following: I) Comedones - only comedones; II) Papulopustular - comedones, papules and pustules; III) Nodulocystic - comedones, papules, pustules, nodules and cysts; IV) Conglobates - severe acne, usually affects other areas of the body, out of preference, giving comedones, papules, pustules, abscesses, confluent nodules, cysts and scars.
  • Agreement in compliance with the procedures of the trial and attend the clinic on certain days and times for medical evaluations and scores of injuries acne;
  • Signing of the Term of Free and Informed Consent and agreement of the lowest in the case of patients between 12 and 17 years.

Exclusion Criteria:

  • Pregnancy (pregnancy test by urinary indication to women voluntary of childbearing age);
  • Nursing;
  • Nodulocystic and Conglobates acne;
  • Conditions associated hormone (tireoid disease, micropolicysts ovaries, adrenal or pituitary disorders);
  • Drug use systemic corticosteroids, anticonvulsants, photo-sensibility and / or new drugs for up to 01 months before the selection;
  • Use of topical therapy, systemic or physical (cleaning of the skin) for the treatment of acne at least 01 months before the selection;
  • History of atopic or allergic skin;
  • History of hypersensitivity to Benzoyl peroxide or sulfur;
  • Skin Conditions active (and / or spread) that may interfere with the outcome of the study;
  • Beginning or end-use of contraceptives; (for females)
  • Sunlight intense exposure until 01 months before the assessment;
  • Aesthetic treatments, skin up to 01 months before the selection;
  • Use of specific oily cosmetic for skin / acne and makeup, facial moisturizing, etc..;
  • Use of the drug Acnase prior to inclusion in the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00877409

Contacts
Contact: Sergio Schalka, MD 55-11-36546362 sergio@medcinonline.com.br

Locations
Brazil
Medcin Instituto da Pele Ltda. Not yet recruiting
Osasco, São Paulo, Brazil, 06023-000
Contact: Sergio Schalka, MD    55-11-36546362    sergio@medcinonline.com.br   
Principal Investigator: Sergio Schalka, MD         
Sponsors and Collaborators
Zurita Laboratorio Farmaceutico Ltda.
Investigators
Principal Investigator: Sérgio Schalka, MD Medcin Instituto da Pele Ltda
  More Information

No publications provided

Responsible Party: Zurita Laboratorio Farmaceutico Ltda.
ClinicalTrials.gov Identifier: NCT00877409     History of Changes
Other Study ID Numbers: EAA461-08/v8, EAA461-08/v8
Study First Received: April 6, 2009
Last Updated: April 6, 2009
Health Authority: Brazil: Ethics Committee
Brazil: National Health Surveillance Agency

Keywords provided by Zurita Laboratorio Farmaceutico Ltda.:
Acnase
Acne Vulgaris
Safety
Efficacy

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Benzoyl Peroxide
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014