Clinical trial NCT01244256: Efficacy and Comparative of the Association Beclomethasone Clotrimzaol + Gentamicin in Patients With Acne Contaminated
Official title: Isolation and Comparative Efficacy of the Combination of beclometasona0, 025% + Gentamicin 0.1% + Clotrimazole 1% Topical Dermatological Cream of GLENMARK PHARMACEUTICALS, in Patients Infected With Acne
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE2
PHASE3
Conditions: Folliculitis
Lead sponsor: Azidus Brasil
Sponsor class: INDUSTRY
First posted: 2010-11-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this trial is to evaluate the comparative efficacy of the combination of Clotrimazole + Gentamicin + Beclomethasone in study subjects with a condition of contaminated dermatosis showing bilateral symmetrical lesions.

Detailed description: The specific objective is to evaluate, by means of analytical propedeutics medical improvement in clinical signs and symptoms related to acne infected, the use of the association: Clotrimazole, Gentamicin and Beclomethasone versus association: Clotrimazole and Gentamicin, which will first be randomized.

The study should be conducted with 20 research subjects aged over 18 years, of both sexes, showing the framework of bilateral lesions infected with acne, at any stage of evolution. The study subjects will receive treatment with both products, so they can use one in each lesion chosen at random, double-blind.

Thus, the proven efficacy and safety and taking all possible adverse events reported, the study sponsor hopes to obtain registration with the Ministry of Health of this new association in the country.

The association made a proposal was developed by the Laboratory Glenmark Pharmaceuticals Ltd..

Eligibility criteria: Inclusion Criteria:

* Subject search of both sexes, regardless of color or social class
* From age to 18, with good mental health
* Carriers of two outbreaks of acne contaminated
* Subjects who agree to return follow-up visits
* Research subjects who agree to participate and sign the Deed of Consent

Exclusion Criteria:

* Subject Research carriers of susceptibility to gentamicin
* Research subjects suffering from sensitivity to clotrimazole
* Research subjects suffering from sensitivity to beclomethasone
* Research subjects who are making use of steroids or steroidal anti-inflammatory and non-steroidal drugs or who made use of topical or oral 15 days ago
* Research subjects who are doing immunosuppressive treatment
* Research subjects with a diagnosis of eosinophilic folliculitis or Pseudo-folliculitis barbae and groin
* Pregnant and lactating

Primary outcomes:
measure: Efficacy of the treatment in patient with infected dermatoses
timeFrame: 21 days of treatment
Secondary outcomes:
measure: evaluate the safety and tolerability of both formulations in the course of treatmen
timeFrame: 21 days of treatment
Other outcomes:
Locations:
city: Valinhos
country: Brazil
facility: LAL Clinica
state: SP
Study officials:
affiliation: Azidus Brasil
name: Alexandre Frederico, médico
role: PRINCIPAL_INVESTIGATOR
References: