Status:
COMPLETED
A Randomized Comparative Study Evaluating the Tolerability and Efficacy of Two Topical Therapies for the Treatment of Keloids and Hypertrophic Scars
Lead Sponsor:
University of Miami
Conditions:
Keloid
Hypertrophic Scar
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Keloids are thought to result from derailments in the typical wound healing process following cutaneous injury. Current treatment options for keloids include intralesional corticosteroids, silicone ge...
Detailed Description
This study will last up to 16 weeks, with a total of 5 visits to the clinic (Baseline visit, Week 4, 8, 12, and 16 ), excluding the Screening Visit. Screening Visit/Baseline Visit: Patients will rea...
Eligibility Criteria
Inclusion
- Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
- Male or female, at least 18 years old in good general health, that have a hypertrophic and keloid scar. The length of the scar should be between 1-4 cm. Individuals who are willing and able to follow the requirements for study participation
- The investigator believes that the scar could benefit from the study medication.
Exclusion
- Subjects who meet any of the following criteria should be excluded from the study:
- Individuals with target scar that is not amenable to the randomized treatment
- Individuals who are planning pregnancy, or pregnant as determined by urine pregnancy test during the duration of the study, or breast-feeding an infant
- Individuals with uncontrolled diabetes or autoimmune disorders
- Individuals who have received scar treatment within one month of the first day of study treatment
- Individuals who plan to receive scar treatment(s) other than study treatment during the trial
- Individuals with a known sensitivity to any ingredients in the test products
- Individuals with any skin conditions or taking any medications that may interfere with the study medication.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00754247
Start Date
March 1 2006
End Date
February 1 2008
Last Update
July 10 2019
Active Locations (1)
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1
University of Miami Skin Research Group Office
Miami, Florida, United States, 33136