drugset / Trial / NCT03376620

Role of Topical Putrescine (Fibrostat) for Prevention of Hypertrophic Scars in Mammoplasty Patients

NCT03376620 ↗

Phase 3 Completed 56 enrolled University of Manitoba
RandomizedParallel-groupDouble-blindPrevention

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. 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.

Timeline

Start
2011-09-02
Primary completion
2013-08-13
Completion
2016-07-15

Drugs

EvaluationDrugModalityDoseRoute
Comparator 1,4 diaminobutane Unknown 0.8 % Topical