Hypertrophic Scar Clinical Trial
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT03935594 -
Use of Autologous Platelet-Rich Plasma to Treat Hypertrophic Burn Scars
|
Phase 2 | |
Recruiting |
NCT03561376 -
Zinc Oxide Versus Petrolatum Following Skin Surgery
|
Early Phase 1 | |
Recruiting |
NCT06033430 -
Effectiveness of Dry Needling in Linear Scar Tissue
|
N/A | |
Recruiting |
NCT03631368 -
Treatment of Hypertrophic Scars With Intradermal Botox
|
Phase 2 | |
Completed |
NCT03630198 -
Pain Outcomes Following Intralesional Corticosteroid Injections
|
Phase 4 | |
Recruiting |
NCT02168634 -
The Use of Botulinum Toxin in the Treatment of Itching From Hypertrophic Scar -- A Randomised Controlled Trial
|
N/A | |
Completed |
NCT02030275 -
A Study to Evaluate the Effectiveness and Safety of RXI 109 on the Outcome of Scar Revision Surgery in Healthy Adults
|
Phase 2 | |
Recruiting |
NCT04506255 -
Silicone Taping for the Improvement of Abdominal Donor Site Scars
|
N/A | |
Not yet recruiting |
NCT04593706 -
Comparison of the Efficacy of Different Steroids in the Treatment of Abnormal Scars (Keloids, Hypertrophic Scars)
|
N/A | |
Completed |
NCT04643223 -
Effect of Elastic Bandage With Tension on the Inflammatory Response of Hypertrophic Scars
|
N/A | |
Completed |
NCT03986346 -
The Vascularity Changes of Scars With Laser Therapy
|
N/A | |
Completed |
NCT04619589 -
Characterization of Dyschromic Hypertrophic Scar
|
||
Completed |
NCT05412745 -
Class I Medical Device on Post-surgical Scars
|
N/A | |
Completed |
NCT06347081 -
Effect of Nd-YAG Laser on Hypertrophic Scar
|
N/A | |
Terminated |
NCT03403621 -
Hypertrophic Scar Prevention by Novel Topical Gel Application
|
Phase 1/Phase 2 | |
Completed |
NCT00754247 -
A Randomized Comparative Study Evaluating the Tolerability and Efficacy of Two Topical Therapies for the Treatment of Keloids and Hypertrophic Scars
|
Phase 4 | |
Recruiting |
NCT03692273 -
Randomized Control Trial of CO2 Laser to Treat Hypertrophic Burn Scar
|
N/A | |
Completed |
NCT03795116 -
Light Emitting Diode-Red Light (LED-RL) Phototherapy for Skin Scarring Prevention
|
Phase 2 | |
Not yet recruiting |
NCT03850119 -
Nanofat on Wound Healing and Scar Formation
|
N/A | |
Recruiting |
NCT04364217 -
Pain and Itch Reduction in Burn Scars Treated With Fractional CO2 Laser
|
N/A |