Hypertrophic ScarPhase 3NCT03376620
Role of Topical Putrescine (Fibrostat) for Prevention of Hypertrophic Scars in Mammoplasty Patients
A Phase 3 study testing 1,4-Diaminobutane and 10% Urea cream in people with Hypertrophic Scar, run by University of Manitoba.
Trial summary
Linked to previous Clinical Trial E92:069 in which biochemical effect of 1,4 diaminobutane was studied in human scar harvested at revision surgery after a 12 week application. Analytical data was collected in this phase of the work completed in 1999. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertrophic Scar
- What is being tested?
- 1,4-Diaminobutane and 10% Urea cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- 2 Sep 2011to 15 Jul 2016
- Phase
- Phase 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 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- -
About this study
Official title: Role of Topical Putrescine (Fibrostat) in 10%Urea (TFU) for Prevention of Hypertrophic Scars in Mammoplasty Patients
Linked to previous Clinical Trial E92:069 in which biochemical effect of 1,4 diaminobutane was studied in human scar harvested at revision surgery after a 12 week application. Analytical data was collected in this phase of the work completed in 1999. This was then followed by clinical correlation in a scar prevention model with topical application of 1,4 diaminobutane for 12 weeks and measuring duredness , as well photographic and POSAS score data for quality of scar formation.
Read the detailed description
In this study, patients were "randomized" into one of 2 study groups described below. They agreed to being treated on the right side or the left with active agent, while the other side was to receive inactive cream. The active molecule is called Fibrostat or 1,4 diaminobutane and is a naturally occurring inhibitor of scar formation. The inactive jar contains the vehicle alone without Fibrostat.
The patients received both cream types to be applied to the appropriate side assigned by the randomization process, one numbered jar each per breast in the order and amount as explained in detail by the patient educator. The cream was applied daily and in the same order, one jar for the right and the other jar for the left consistently. The randomization was performed at the factory with an assigned number recorded on each jar and the jar contents listed and recorded with its assigned number. Each jar of active cream is randomly assigned with another jar of inactive cream to form a pair which were both given to the patient. The cream in both jars looks and smells the same. Neither the patient nor the study doctor knew which breast as receiving the active agent. In an emergency, this information was to be made available.
Participation in the study was for 12 weeks. the patients were seen for photos and scar testing using a painless surface testing device called a Rex® durometer at 1, 3, 6, and 12 weeks post op.
The researcher could decide to take patients off this study if a patient were to develop a rash during the run-in period of 1 week from the cream on either side.
The patients could stop participating at any time. However, this was usually accompanied by a valid reason such as lack of transportation to regular follow up appointments. No serious effects were seen and the only patients to stop participation in the study except 1 which was lost to follow-up could be accounted for. The results were revealed to patients at the completion of the 12 week trial.
- Conditions
- Hypertrophic Scar
- Being tested
- 1,4-Diaminobutane, 10% Urea cream
- Keywords
- Prevention of hypertrophic scar
- Medical subject headings
- Cicatrix, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1,4-DiaminobutaneDrug
Also called Fibrostat
Daily application to surgical breast scars of 1,4 diaminobutane on the active side
10% Urea creamDrug
Daily application to surgical breast scars of 10% Urea cream on the sham side
| Study group | Role | What they receive |
|---|---|---|
| 10% Urea cream | Sham comparator | Opposite breast scars treated OD at hs simultaneously using sham 10% Urea cream Receives: Drug: 10% Urea cream |
| Active cream with 1,4 diaminobutane | Active comparator | Other breast scar treated daily with active cream with 1,4 diaminobutane topically OD at hs Receives: Drug: 1,4-Diaminobutane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duredness of scar at post treatment time frame for active versus control breast
Surface deformational force in grams of scar tissue in each of the treated breasts
Measured: 12 weeks
Secondary outcomes (1)
Patient Observer Objective Scar Assessment Scale ratings
Validated scale of scar outcome based on seven parameters graded on a scale of 1-10 ranked lowest to highest in severity. Patient was the "observer" in this study making subjective parameters listed such as pain and itch a direct patient correlate rather than one recorded by a second-person observation.
Measured: at least one year post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2017
- Study start2 Sep 2011
- Primary completion13 Aug 2013
- Study completion15 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypertrophic ScarStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-Blind Randomized Controlled Trial; Patient as their own control
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03376620
- Sponsor's protocol ID
- B2008:134
- Status last verified
- Nov 2017
- First submitted
- 13 Dec 2017
- Last updated
- 20 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dolynchuk KN, Tredget EE. A Preliminary Report of the Biochemical and Clinical Effects of 1,4-Diaminobutane on Prevention of Human Hypertrophic Scars. Plast Reconstr Surg. 2020 Jan;145(1):76e-84e. doi: 10.1097/PRS.0000000000006413.
PubMed 31881614
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Topical Putrescine (Fibrostat) in 10%Urea (TFU) for Prevention of Hypertrophic Scars in Mammoplasty Patients
- ClinicalTrials.gov ID
- NCT03376620
- Acronym / sponsor ID
- B2008:134
- Conditions
- Hypertrophic Scar
- Keywords
- Prevention of hypertrophic scar
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 2 Sep 2011 (actual)
- Primary completion
- 13 Aug 2013 (actual)
- Study completion
- 15 Jul 2016 (actual)
- First posted
- 18 Dec 2017 (actual)
- 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.
Linked to previous Clinical Trial E92:069 in which biochemical effect of 1,4 diaminobutane was studied in human scar harvested at revision surgery after a 12 week application. Analytical data was collected in this phase of the work completed in 1999. This was then followed by clinical correlation in a scar prevention model with topical application of 1,4 diaminobutane for 12 weeks and measuring duredness , as well photographic and POSAS score data for quality of scar formation.
Detailed description
In this study, patients were "randomized" into one of 2 study groups described below. They agreed to being treated on the right side or the left with active agent, while the other side was to receive inactive cream. The active molecule is called Fibrostat or 1,4 diaminobutane and is a naturally occurring inhibitor of scar formation. The inactive jar contains the vehicle alone without Fibrostat.
The patients received both cream types to be applied to the appropriate side assigned by the randomization process, one numbered jar each per breast in the order and amount as explained in detail by the patient educator. The cream was applied daily and in the same order, one jar for the right and the other jar for the left consistently. The randomization was performed at the factory with an assigned number recorded on each jar and the jar contents listed and recorded with its assigned number. Each jar of active cream is randomly assigned with another jar of inactive cream to form a pair which were both given to the patient. The cream in both jars looks and smells the same. Neither the patient nor the study doctor knew which breast as receiving the active agent. In an emergency, this information was to be made available.
Participation in the study was for 12 weeks. the patients were seen for photos and scar testing using a painless surface testing device called a Rex® durometer at 1, 3, 6, and 12 weeks post op.
The researcher could decide to take patients off this study if a patient were to develop a rash during the run-in period of 1 week from the cream on either side.
The patients could stop participating at any time. However, this was usually accompanied by a valid reason such as lack of transportation to regular follow up appointments. No serious effects were seen and the only patients to stop participation in the study except 1 which was lost to follow-up could be accounted for. The results were revealed to patients at the completion of the 12 week trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Double-Blind Randomized Controlled Trial; Patient as their own control
| Arm | Type | Receives |
|---|---|---|
| 10% Urea cream | Sham comparator | Drug: 10% Urea creamOpposite breast scars treated OD at hs simultaneously using sham 10% Urea cream |
| Active cream with 1,4 diaminobutane | Active comparator | Drug: 1,4-DiaminobutaneOther breast scar treated daily with active cream with 1,4 diaminobutane topically OD at hs |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| 1,4-DiaminobutaneAlso: FibrostatDaily application to surgical breast scars of 1,4 diaminobutane on the active side | Drug | Active cream with 1,4 diaminobutane |
| 10% Urea creamDaily application to surgical breast scars of 10% Urea cream on the sham side | Drug | 10% Urea cream |
Primary outcome
Duredness of scar at post treatment time frame for active versus control breast
Time frame: 12 weeks
Surface deformational force in grams of scar tissue in each of the treated breasts
1 secondary outcome
Patient Observer Objective Scar Assessment Scale ratings
Time frame: at least one year post operatively
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 20 Dec 2017.
- Derived from this study: PubMed 31881614Dolynchuk KN, Tredget EE. A Preliminary Report of the Biochemical and Clinical Effects of 1,4-Diaminobutane on Prevention of Human Hypertrophic Scars. Plast Reconstr Surg. 2020 Jan;145(1):76e-84e. doi: 10.1097/PRS.0000000000006413.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 1,4-Diaminobutane and 10% Urea cream in people with Hypertrophic Scar, run by University of Manitoba.
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 0 inclusion and 1 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 20 Dec 2017. 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 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?
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?
Duredness of scar at post treatment time frame for active versus control breast (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03376620, which also lists 1 linked publication.
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 20 Dec 2017.