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

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

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.

Study Overview

• Status: Suspended
• Conditions: Folliculitis
• Intervention / Treatment: Drug: Clotrimazole + Gentamicin + Beclomethasone; Drug: Clotrimazole + Gentamicin

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..

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Valinhos, SP, Brazil, 13276245
      • LAL Clínica

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment with Clotrimazole + Gentamicin + Beclomethasone	Drug: Clotrimazole + Gentamicin + Beclomethasone; Treatment with Clotrimazole + Gentamicin + Beclomethasone
Active Comparator: Treatment with Clotrimazole + Gentamicin	Drug: Clotrimazole + Gentamicin; Treatment with Clotrimazole + Gentamicin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Efficacy of the treatment in patient with infected dermatoses	21 days of treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
evaluate the safety and tolerability of both formulations in the course of treatmen	21 days of treatment

Collaborators and Investigators

• Sponsor: Azidus Brasil
• Investigators: Principal Investigator: Alexandre Frederico, médico, Azidus Brasil

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2007
• Primary Completion (Actual): August 1, 2007
• Study Completion: September 1, 2007

Study Registration Dates

• First Submitted: October 22, 2010
• First Submitted That Met QC Criteria: November 18, 2010
• First Posted (Estimate): November 19, 2010

Study Record Updates

• Last Update Posted (Actual): November 3, 2022
• Last Update Submitted That Met QC Criteria: November 1, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Hair Diseases; Folliculitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Anti-Asthmatic Agents; Respiratory System Agents; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Gentamicins; Clotrimazole; Miconazole; Beclomethasone
• Other Study ID Numbers: BCGGLE10407