Deep Partial Thickness BurnPhase 4rhGM-CSFNCT01785784
Efficacy and Safety Study of rhGM-CSF Gel to Treat Deep 2nd Thickness Burn
A Phase 4 study testing rhGM-CSF Gel in people with Deep Partial Thickness Burn, run by Changchun GeneScience Pharmaceutical Co., Ltd..
Trial summary
This was a multicenter, randomized, phase Ⅳ study, to investigate the extensive efficacy and safety of Recombinant Human Granulocyte/Macrophage Colony-stimulating Factor Hydro-gel for Topical Application (rhGM-CSF Gel) on deep 2nd burn. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Deep Partial Thickness Burn
- What is being tested?
- rhGM-CSF Gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,510 participants
- Where
- No sites listed yet
- Study dates
- Nov 2010to Jul 2012
- Phase
- Phase 4
- 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 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- age is not less than 3 years old, any gender is ok.
- the subject who is diagnosed as deep 2nd thickness burn
- the subject who was not administrated with any other topical durg on wound surface before enrolled in the clinical study.
- the subject who sign the <informed consent>
Who cannot join
- age is less than 3 years old
- the subject who participated in any other clinical trial within 3 months
- the subject who was administrated with any other topical drug on wound surface before enrolled in the clinical study
- the female subject who is in lactation or pregnancy
- the subject who are allergic to rhGM-CSF, or has the allergic history to many drug products or has the allergic disease recently
- the subject who has serious heart disease, unstable angina pectoris break out, cardiac functional insufficiency, myocardial infarction or serious general infection.
Show all 9Show fewer
- the subject who has serious renal inadequacy, creatinine(Cr) is more than 2.5 times of the upper limit
- aspartate aminotransferase or alanine transpeptidase is more than 2.5 times of the upper limit
- the subject who use immunosuppressant
About this study
Official title: Phase IV Clinical Trial of rhGM-CSF Hydro-gel for Topical Application on Deep 2nd Partial Thickness Burn
This was a multicenter, randomized, phase Ⅳ study, to investigate the extensive efficacy and safety of Recombinant Human Granulocyte/Macrophage Colony-stimulating Factor Hydro-gel for Topical Application (rhGM-CSF Gel) on deep 2nd burn.
There are two parts of the phase Ⅳstudy, the first part was a multicenter, randomized, reference controlled study, all the subjects were randomized into two groups, test group (rhGM-CSF Gel) and control group (iodophor gauze), totally 358 deep 2nd burned patients were enrolled in first part of the study, 177 cases were enrolled in test group and 181 cases were enrolled in reference control group. In the test group, after the patients were enrolled in the group, clean the wound surface regularly and wash with normal saline, spread the test drug on the wound surface, bandaging with sterilized vaseline gauze, change the drug product every two or one day according to the effusion. In the reference control group, after the patients were enrolled in the group, clean the wound surface regularly and wash with normal saline, bandaging with iodophor gauze, change the drug product every two or one day according to the effusion. Whole treatment were lasted till the wound surface was healing completely, if it is not recovered in 4 weeks, calculate and record the healing rate. The secondary part of the study was a multicenter, open study, to investigate the safety of rhGM-CSF on deep 2nd burn patients. Totally 2329 patients were enrolled in this part of the study.
- Conditions
- Deep Partial Thickness Burn
- Being tested
- rhGM-CSF Gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhGM-CSF GelDrug
| Study group | Role | What they receive |
|---|---|---|
| burn patients | Experimental | Not described Receives: Drug: rhGM-CSF Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
100% healing time of the wound surface
Measured: 4 weeks
Secondary outcomes (2)
appearance of the wound surface
If the 100% healing date of the wound surface is less than 28 days, record the result until the 100% healing day.
Measured: day 0, day 2, day 4, day 6, day 8, day 10, day 12, day 14, day16, day 18, day 20, day 22, day 24, day 26, day 28
healing rate of the wound surface
If the 100% healing date of the wound surface is less than 28 days, record the result until the 100% healing day.
Measured: Day 8, day 10, day 12, day14, day 16, day 18, day 20, day22, day 24, day26 and day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2013 (estimated)
- Study startNov 2010
- Primary completionApr 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Partial Thickness BurnStudies of the same condition, open and under way.
- More trials run by Changchun GeneScience Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,510 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Jiao Tong University School of Medicine, Beijing Children's Hospital, Third Military Medical University
- Responsible party
- Sponsor
- Investigators
- Liao Zh Jiang, Doctor, Principal investigator, Affiliated Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01785784
- Sponsor's protocol ID
- GenSci-002-CT
- Acronym
- rhGM-CSF
- Status last verified
- Feb 2013
- First submitted
- 28 Jan 2013
- Last updated
- 7 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Clinical Trial of rhGM-CSF Hydro-gel for Topical Application on Deep 2nd Partial Thickness Burn
- ClinicalTrials.gov ID
- NCT01785784
- Acronym / sponsor ID
- rhGM-CSF / GenSci-002-CT
- Conditions
- Deep Partial Thickness Burn
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,510 participants (actual)
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Jiao Tong University School of Medicine, Beijing Children's Hospital, Third Military Medical University
- Study start
- Nov 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 7 Feb 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.
This was a multicenter, randomized, phase Ⅳ study, to investigate the extensive efficacy and safety of Recombinant Human Granulocyte/Macrophage Colony-stimulating Factor Hydro-gel for Topical Application (rhGM-CSF Gel) on deep 2nd burn.
There are two parts of the phase Ⅳstudy, the first part was a multicenter, randomized, reference controlled study, all the subjects were randomized into two groups, test group (rhGM-CSF Gel) and control group (iodophor gauze), totally 358 deep 2nd burned patients were enrolled in first part of the study, 177 cases were enrolled in test group and 181 cases were enrolled in reference control group. In the test group, after the patients were enrolled in the group, clean the wound surface regularly and wash with normal saline, spread the test drug on the wound surface, bandaging with sterilized vaseline gauze, change the drug product every two or one day according to the effusion. In the reference control group, after the patients were enrolled in the group, clean the wound surface regularly and wash with normal saline, bandaging with iodophor gauze, change the drug product every two or one day according to the effusion. Whole treatment were lasted till the wound surface was healing completely, if it is not recovered in 4 weeks, calculate and record the healing rate. The secondary part of the study was a multicenter, open study, to investigate the safety of rhGM-CSF on deep 2nd burn patients. Totally 2329 patients were enrolled in this part of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| burn patients | Experimental | Drug: rhGM-CSF Gel |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- age is not less than 3 years old, any gender is ok.
- the subject who is diagnosed as deep 2nd thickness burn
- the subject who was not administrated with any other topical durg on wound surface before enrolled in the clinical study.
- the subject who sign the <informed consent>
Key exclusion criteria (9 listed)
- age is less than 3 years old
- the subject who participated in any other clinical trial within 3 months
- the subject who was administrated with any other topical drug on wound surface before enrolled in the clinical study
- the female subject who is in lactation or pregnancy
- the subject who are allergic to rhGM-CSF, or has the allergic history to many drug products or has the allergic disease recently
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 |
|---|---|---|
| rhGM-CSF Gel | Drug | burn patients |
Primary outcome
100% healing time of the wound surface
Time frame: 4 weeks
2 secondary outcomes
appearance of the wound surface
Time frame: day 0, day 2, day 4, day 6, day 8, day 10, day 12, day 14, day16, day 18, day 20, day 22, day 24, day 26, day 28
healing rate of the wound surface
Time frame: Day 8, day 10, day 12, day14, day 16, day 18, day 20, day22, day 24, day26 and day 28
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 7 Feb 2013.
Related trials for Deep Partial Thickness Burn
RecruitingPhase 3
Phase III Study With an Autologous Dermo-epidermal Skin Substitute for the Treatment of Burns in Adults and Adolescents
Burns
Active, not recruitingPhase 2
Study With an Autologous Dermo-epidermal Skin Substitute for the Treatment of Burns in Children
Burns
Enrolling by invitationPhase 4
Evaluating Whether Intact Fish Skin Graft Can Decrease the Need for Autograft in the Treatment of Deep Partial-Thickness Burns
Partial-thickness Burn Wounds
RecruitingPhase 2
Phase II Clinical Trial of KJ101in the Treatment of Deep II Degree Burns
Burn, Burn Wounds - Partial Thickness (2nd Degree)
RecruitingPhase 3
Safety and Efficacy of realSKIN® to Provide Complete Wound Closure of Burn Wounds as an Alternative to Autografting
Burns Degree Third, Burn (Disorder)
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.
Liao Zh Jiang, Doctor principal investigator
Affiliated Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing rhGM-CSF Gel in people with Deep Partial Thickness Burn, run by Changchun GeneScience Pharmaceutical Co., Ltd..
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 4 inclusion and 9 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 7 Feb 2013. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
100% healing time of the wound surface (time frame: 4 weeks). 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 7 Feb 2013.