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

Folliculitis Clinical Trial

— acne  

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01244256
• Other study ID #: BCGGLE10407
• Status: Suspended
• Phase: Phase 2/Phase 3
• Start date: April 2007
• Est. completion date: September 2007

Study information

• Verified date: November 2022
• Source: Azidus Brasil
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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..

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 80
• Est. completion date: September 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Folliculitis

Intervention

Drug:
• Clotrimazole + Gentamicin + Beclomethasone
Treatment with Clotrimazole + Gentamicin + Beclomethasone
• Clotrimazole + Gentamicin
Treatment with Clotrimazole + Gentamicin

Locations

Country	Name	City	State
Brazil	LAL Clinica	Valinhos	SP

Sponsors (1)

Lead Sponsor	Collaborator
Azidus Brasil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of the treatment in patient with infected dermatoses		21 days of treatment
Secondary	evaluate the safety and tolerability of both formulations in the course of treatmen		21 days of treatment