Efficacy and Comparative of the Association Beclomethasone Clotrimzaol + Gentamicin in Patients With Acne Contaminated (acne)

Azidus

Status and phase

Suspended

Phase 3

Phase 2

Conditions

Folliculitis

Treatments

Drug: Clotrimazole + Gentamicin

Drug: Clotrimazole + Gentamicin + Beclomethasone

Study type

Interventional

Funder types

Industry

Identifiers

NCT01244256

BCGGLE10407

Details and patient eligibility

About

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.

Full 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..

Enrollment

80 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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