Secondarily Infected Traumatic Skin LesionsPhase 1NCT01876550
A Study to Evaluate the Safety and Bioequivalence of Mupirocin Calcium Cream, 2% and Bactroban® Cream and Compare Both to a Vehicle in Treatment of Secondarily Infected Traumatic Skin Lesions.
A Phase 1 study testing Mupirocin Calcium Cream, 2% and Bactroban® Cream in people with Secondarily Infected Traumatic Skin Lesions, run by Sun Pharmaceutical Industries, Inc..
Trial summary
The primary objective of this study is to determine the comparability of the safety and efficacy of Mupirocin Calcium Cream, 2% and Bactroban® Cream in subjects with secondarily infected traumatic skin lesions. Read more about this study
- Who is it for?
- Ages 18 months and older
- Conditions the study is for
- Secondarily Infected Traumatic Skin Lesions
- What is being tested?
- Mupirocin Calcium Cream, 2% and Bactroban® Cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,902 participants
- Where
- No sites listed yet
- Study dates
- Feb 2013to 6 May 2019
- Phase
- Phase 1
- 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 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Healthy male or nonpregnant females aged 18 months or older with a secondarily infected traumatic skin lesion such as a laceration, sutured wound, or abrasion.
- The laceration or sutured wound should not exceed 10 cm in length with surrounding erythema not more than 2 cm from the edge of the lesion. An abrasion should not exceed 100 cm2 in total area with surrounding erythema not more than 2 cm from the edge of the abrasion.
- Positive baseline culture for S. aureus and/or S. pyogenes from a sample taken from the secondarily infected traumatic skin lesion.
- Positive Gram stain or Wright stain for confirmation of white blood cells in the pus/exudate from the secondarily infected traumatic skin lesion.
- Skin Infection Rating Scale total score for the secondarily infected traumatic skin lesion of at least 8 at baseline.
- Women of childbearing potential, in addition to having a negative urine pregnancy test, must be willing to use an acceptable form of birth control during the study. Subjects entering the study who are on hormonal contraceptives must have been on the method for at least 90 days prior to the study and continue the method for the duration of the study. Subjects who had used hormonal contraception and stopped must have stopped no less than 90 days prior to the study.
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- Subjects 18 years of age or older must provide Institutional Review Board approved written informed consent. Subjects under the age of 18 years must have parent or legal guardian provide Institutional Review Board approved written consent. An assent form for minors must be completed for subjects under the legal age of consent, depending on the age range required by state laws.
- Subjects must be willing and able to understand and comply with the requirements of the study, apply the medication as instructed, return for the required study visits, comply with therapy prohibitions, and be able to complete the study.
- Subjects must be in good health and free from any clinically significant disease, other than secondarily infected traumatic skin lesions, that might interfere with the study evaluations.
Who cannot join
- Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period.
- Any dermatological disorder that may interfere with evaluation of the subject's secondarily infected traumatic skin lesion(s).
- Bacterial skin infection that, because of depth or severity, could not be appropriately treated with a topical antibiotic.
- Secondarily infected bite or puncture wound.
- Systemic signs or symptoms of infection.
- Requirement for surgical intervention for treatment of the infection prior to study entry.
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- A subject must not have received any topical corticosteroid, topical antibiotic, or antifungal agent for at least 48 hours (2 days) prior to baseline.
- A subject must not have received any systemic antibiotic or systemic corticosteroid for at least 7 days prior to baseline.
- Primary or secondary immunodeficiency.
- Diabetes.
- Presence of any other medical condition that might adversely affect the safety of the study participants or confound the study results.
- History of hypersensitivity or allergy to mupirocin and/or any of the study medication ingredients.
- Subjects who consume excessive amounts of alcohol, abuse drugs, or have any condition that would compromise compliance with the protocol.
- Treatment with an investigational drug or device within 30 days prior to study entry.
- Previously enrollment in this study.
About this study
Official title: A Double-Blind, Randomized, Parallel-Group, Vehicle-Controlled, Multicenter Study to Evaluate the Safety and Bioequivalence of a Generic Mupirocin Calcium Cream, 2% and Reference Listed Bactroban® Cream (Mupirocin Calcium Cream, 2%) and Compare Both Active Treatments to a Vehicle Control in the Treatment of Secondarily Infected Traumatic Skin Lesions.
The primary objective of this study is to determine the comparability of the safety and efficacy of Mupirocin Calcium Cream, 2% and Bactroban® Cream in subjects with secondarily infected traumatic skin lesions. It will also be determined whether the efficacy of each of the active treatments is superior to that of the vehicle cream (placebo).
- Being tested
- Mupirocin Calcium Cream, 2%, Bactroban® Cream, Cream vehicle of test product
- Keywords
- Mupirocin Calcium Cream 2%, Bactroban® Cream, Secondarily infected traumatic skin lesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mupirocin Calcium Cream, 2%Drug
Mupirocin Calcium Cream, 2% (Taro Pharmaceuticals Inc.) applied topically 3 times per day for 10 consecutive days.
Bactroban® CreamDrug
Bactroban® Cream (mupirocin calcium cream, 2%) (GlaxoSmithKline) applied topically 3 times per day for 10 consecutive days.
Cream vehicle of test productDrug
Cream vehicle of test product (Taro Pharmaceuticals Inc.) applied topically 3 times per day for 10 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Mupirocin Calcium Cream, 2% | Experimental | Mupirocin Calcium Cream, 2% (Taro Pharmaceuticals Inc.) Receives: Drug: Mupirocin Calcium Cream, 2% |
| Bactroban® Cream | Active comparator | Bactroban® Cream (mupirocin calcium cream, 2%) (GlaxoSmithKline) Receives: Drug: Bactroban® Cream |
| Cream vehicle of test product | Placebo comparator | Cream vehicle of test product (Taro Pharmaceuticals Inc.) Receives: Drug: Cream vehicle of test product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical cure at visit 4
The proportion of subjects in each treatment group with clinical cure, defined as an SIRS score of 0 for all signs and symptoms at Visit 4/Follow-up (7 days after the end of treatment).
Measured: 7 days after end of treatment
Secondary outcomes (3)
Clinical cure at visit 3
The proportion of subjects with clinical cure at Visit 3/End of Treatment.
Measured: Day 10 (visit 3)
Bacteriological cure at visit 3
The proportion of subjects with bacteriological cure, defined as elimination of S.aureus and S. pyogenes or response was such that no culture material was available and therefore evidence of pathogen eradication, at Visit 3/End of Treatment.
Measured: Day 10 (visit 3)
Bacteriological cure at visit 4
Proportion of subjects with bacteriological cure at Visit 4/Follow-up.
Measured: 7 days after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2013 (estimated)
- Study startFeb 2013
- Primary completionFeb 2014
- Study completion6 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondarily Infected Traumatic Skin LesionsStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,902 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Symbio CRO, Study chair, http://symbioresearch.comCatawba Research, LLC, Study chair, https://catawbaresearch.com/
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01876550
- Sponsor's protocol ID
- MUPC 1106/1305
- Status last verified
- May 2019
- First submitted
- 10 Jun 2013
- Last updated
- 9 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Parallel-Group, Vehicle-Controlled, Multicenter Study to Evaluate the Safety and Bioequivalence of a Generic Mupirocin Calcium Cream, 2% and Reference Listed Bactroban® Cream (Mupirocin Calcium Cream, 2%) and Compare Both Active Treatments to a Vehicle Control in the Treatment of Secondarily Infected Traumatic Skin Lesions.
- ClinicalTrials.gov ID
- NCT01876550
- Acronym / sponsor ID
- MUPC 1106/1305
- Keywords
- Mupirocin Calcium Cream 2%, Bactroban® Cream, Secondarily infected traumatic skin lesions
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,902 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- 6 May 2019 (actual)
- First posted
- 12 Jun 2013 (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 primary objective of this study is to determine the comparability of the safety and efficacy of Mupirocin Calcium Cream, 2% and Bactroban® Cream in subjects with secondarily infected traumatic skin lesions. It will also be determined whether the efficacy of each of the active treatments is superior to that of the vehicle cream (placebo).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mupirocin Calcium Cream, 2% | Experimental | Drug: Mupirocin Calcium Cream, 2%Mupirocin Calcium Cream, 2% (Taro Pharmaceuticals Inc.) |
| Bactroban® Cream | Active comparator | Drug: Bactroban® CreamBactroban® Cream (mupirocin calcium cream, 2%) (GlaxoSmithKline) |
| Cream vehicle of test product | Placebo comparator | Drug: Cream vehicle of test productCream vehicle of test product (Taro Pharmaceuticals Inc.) |
Who may qualify
- Ages
- 18 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Healthy male or nonpregnant females aged 18 months or older with a secondarily infected traumatic skin lesion such as a laceration, sutured wound, or abrasion.
- The laceration or sutured wound should not exceed 10 cm in length with surrounding erythema not more than 2 cm from the edge of the lesion. An abrasion should not exceed 100 cm2 in total area with surrounding erythema not more than 2 cm from the edge of the abrasion.
- Positive baseline culture for S. aureus and/or S. pyogenes from a sample taken from the secondarily infected traumatic skin lesion.
- Positive Gram stain or Wright stain for confirmation of white blood cells in the pus/exudate from the secondarily infected traumatic skin lesion.
- Skin Infection Rating Scale total score for the secondarily infected traumatic skin lesion of at least 8 at baseline.
Key exclusion criteria (15 listed)
- Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period.
- Any dermatological disorder that may interfere with evaluation of the subject's secondarily infected traumatic skin lesion(s).
- Bacterial skin infection that, because of depth or severity, could not be appropriately treated with a topical antibiotic.
- Secondarily infected bite or puncture wound.
- Systemic signs or symptoms of infection.
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 |
|---|---|---|
| Mupirocin Calcium Cream, 2%Mupirocin Calcium Cream, 2% (Taro Pharmaceuticals Inc.) applied topically 3 times per day for 10 consecutive days. | Drug | Mupirocin Calcium Cream, 2% |
| Bactroban® CreamBactroban® Cream (mupirocin calcium cream, 2%) (GlaxoSmithKline) applied topically 3 times per day for 10 consecutive days. | Drug | Bactroban® Cream |
| Cream vehicle of test productCream vehicle of test product (Taro Pharmaceuticals Inc.) applied topically 3 times per day for 10 consecutive days. | Drug | Cream vehicle of test product |
Primary outcome
Clinical cure at visit 4
Time frame: 7 days after end of treatment
The proportion of subjects in each treatment group with clinical cure, defined as an SIRS score of 0 for all signs and symptoms at Visit 4/Follow-up (7 days after the end of treatment).
3 secondary outcomes
Clinical cure at visit 3
Time frame: Day 10 (visit 3)
Bacteriological cure at visit 3
Time frame: Day 10 (visit 3)
Bacteriological cure at visit 4
Time frame: 7 days after end of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2019.
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.
Symbio CRO study chair
http://symbioresearch.com
Catawba Research, LLC study chair
https://catawbaresearch.com/
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mupirocin Calcium Cream, 2% and Bactroban® Cream in people with Secondarily Infected Traumatic Skin Lesions, run by Sun Pharmaceutical Industries, Inc..
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 9 inclusion and 15 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: finished, as of the sponsor's last update on 9 May 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical cure at visit 4 (time frame: 7 days after end 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 9 May 2019.