Status:
TERMINATED
Hypertrophic Scar Prevention by Novel Topical Gel Application
Lead Sponsor:
Mayo Clinic
Conditions:
Hypertrophic Scar
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Researchers are trying to find out more about the side effects of topical (applied to the skin) Pentamidine, to determine if it is safe for use in people. They also want to find out if topical use of ...
Detailed Description
This study will investigate Pentamidine isethionate, compounded in a silicone-containing base, as adjuvant therapy to surgical scar excision to prevent adverse scarring and enhance skin rejuvenation.
Eligibility Criteria
Inclusion
- Diagnosis of hypertrophic scar by a Mayo Clinic plastic surgeon or dermatologist.
- Target disease or condition: Hypertrophic scar
- Subject with a hypertrophic scar that meet all of the following criteria:
- Linear scar ≥5 to ≤40 cm in length
- Present for minimum 6 months
- Located anywhere in the body except on the face or front of neck
- Resulting from surgical or traumatic injury, or other scar considered appropriate for surgical excision
- Ability to safely undergo scar excision surgery
- Capacity to provide informed consent
- Ability to comply with protocol
- Subject is judged, by the clinical investigator, to be healthy as evidenced by lack of clinically significant abnormal findings on medical history, physical examination, electrocardiogram, vital signs, and clinical laboratory tests.
Exclusion
- Subjects identified as having a keloid or a scar not appropriate for surgical excision
- Subjects who are positive for hepatitis B surface antigen (HbsAg), hepatitis C antibody and HIV as determined in screening the subject's electronic medical record.
- Concurrent use of corticosteroids (including inhaled steroids), cyclooxygenase-2 (COX-2) inhibitors and/or drugs that are strong inhibitors and inducers of cytochrome P450 (CYP) enzymes
- Are immuno-compromised (HIV infected, cancer and other disease affecting the basal immune response)
- Clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurological, psychiatric, immunological, gastrointestinal, hematological, or metabolic disease that is, in the opinion of the investigator, not stabilized or may otherwise impact the results of the study.
- Subjects with renal and hepatic impairment.
- Known allergy or hypersensitivity to the study drug(s) or one of the ingredients of the formulation.
- Any infection or wound in the area to treat including photosensitive dermatosis or inflammatory acne.
- Existence of any surgical, medical or laboratory condition that, in the judgment of the clinical investigator, might interfere with the safety, distribution, metabolism or excretion of the drug
- Participation in another clinical study in the past 30 days or concurrent participation in another clinical trial.
- Patients with poorly controlled diabetes mellitus (HbA1C ≥ 8%), peripheral neuropathy, or known concomitant vascular problems.
- Pregnant or lactating female patients.
- Prisoners.
- Subjects who smoke cigarettes and/or use other tobacco products.
Key Trial Info
Start Date :
March 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 26 2020
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT03403621
Start Date
March 5 2018
End Date
February 26 2020
Last Update
November 22 2023
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905