FolliculitisPhase 2/3acneNCT01244256
Efficacy and Comparative of the Association Beclomethasone Clotrimzaol + Gentamicin in Patients With Acne Contaminated
A Phase 2/3 study testing Clotrimazole + Gentamicin + Beclomethasone and Clotrimazole + Gentamicin in people with Folliculitis, run by Azidus Brasil at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Folliculitis
- What is being tested?
- Clotrimazole + Gentamicin + Beclomethasone and Clotrimazole + Gentamicin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2007to Sep 2007
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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..
- Conditions
- Folliculitis
- Being tested
- Clotrimazole + Gentamicin + Beclomethasone, Clotrimazole + Gentamicin
- Medical subject headings
- Folliculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clotrimazole + Gentamicin + BeclomethasoneDrug
Treatment with Clotrimazole + Gentamicin + Beclomethasone
Clotrimazole + GentamicinDrug
Treatment with Clotrimazole + Gentamicin
| Study group | Role | What they receive |
|---|---|---|
| Treatment with Clotrimazole + Gentamicin + Beclomethasone | Experimental | Not described Receives: Drug: Clotrimazole + Gentamicin + Beclomethasone |
| Treatment with Clotrimazole + Gentamicin | Active comparator | Not described Receives: Drug: Clotrimazole + Gentamicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of the treatment in patient with infected dermatoses
Measured: 21 days of treatment
Secondary outcomes (1)
evaluate the safety and tolerability of both formulations in the course of treatmen
Measured: 21 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2010 (estimated)
- Study startApr 2007
- Primary completionAug 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FolliculitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azidus Brasil
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Azidus Brasil, Azidus Brasil
- Investigators
- Alexandre Frederico, médico, Principal investigator, Azidus Brasil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01244256
- Sponsor's protocol ID
- BCGGLE10407
- Acronym
- acne
- Status last verified
- Nov 2022
- First submitted
- 22 Oct 2010
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01244256
- Acronym / sponsor ID
- acne / BCGGLE10407
- Conditions
- Folliculitis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Suspended
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Azidus BrasilIndustry (pharma, biotech, devices)
- Study start
- Apr 2007 (actual)
- Primary completion
- Aug 2007 (actual)
- Study completion
- Sep 2007
- First posted
- 19 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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..
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment with Clotrimazole + Gentamicin + Beclomethasone | Experimental | Drug: Clotrimazole + Gentamicin + Beclomethasone |
| Treatment with Clotrimazole + Gentamicin | Active comparator | Drug: Clotrimazole + Gentamicin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clotrimazole + Gentamicin + BeclomethasoneTreatment with Clotrimazole + Gentamicin + Beclomethasone | Drug | Treatment with Clotrimazole + Gentamicin + Beclomethasone |
| Clotrimazole + GentamicinTreatment with Clotrimazole + Gentamicin | Drug | Treatment with Clotrimazole + Gentamicin |
Primary outcome
Efficacy of the treatment in patient with infected dermatoses
Time frame: 21 days of treatment
1 secondary outcome
evaluate the safety and tolerability of both formulations in the course of treatmen
Time frame: 21 days of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandre Frederico, médico principal investigator
Azidus Brasil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Clotrimazole + Gentamicin + Beclomethasone and Clotrimazole + Gentamicin in people with Folliculitis, run by Azidus Brasil at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of the treatment in patient with infected dermatoses (time frame: 21 days of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022.