Clinical trial NCT03403621: Hypertrophic Scar Prevention by Novel Topical Gel Application
Official title: Double Blind, Single-Center, Randomized, Within Subject Placebo, Phase I Study Evaluating the Effects of Novel Topical Gel in Prevention of Hypertrophic Scar Formation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Hypertrophic Scar
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-01-18
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All participants will receive two treatments: drug and vehicle. Drug will be applied to one of two treatment sites. Vehicle will be applied to the other site. Treatment sites are distal and proximal end of the incision. Drug will be randomized to treatment site "distal" or "proximal" and masking will be as indicated. A 1-2 cm border zone will remain untreated in the middle of the scar.
Primary purpose: PREVENTION

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 Pentamidine can help treat hypertrophic scars.

Pentamidine is a medicine that is currently used to treat certain kinds of infection. It is most often given by intravenous (into a vein) or inhalation (through a breathing device). This medication is approved by the U.S. Food and Drug Administration (FDA) for use in these forms.

Everyone in this study will receive topical Pentamidine (TP) in a silicone based gel (PCCA Pracasil Plus). Topical treatment of Pentamidine is still experimental and has not been formally tested for safety or effectiveness in a randomized control trial within the United States. The FDA has allowed the use of topical Pentamidine in this research study.

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 Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Serious Adverse Events
timeFrame: 4 weeks post-operatively
Secondary outcomes:
measure: Adverse Events
timeFrame: 4 weeks post-operatively
measure: Change in Scar Volume
timeFrame: Baseline (pre-operatively) and at postop week 2 and 4.
measure: Change in Scar Fibrosis
timeFrame: Baseline (preoperatively) and 4 weeks post-operatively.
measure: Change in Scar Sclerosis
timeFrame: Baseline (preoperatively) and 4 weeks post-operatively.
measure: Change in Scar Angioplasia
timeFrame: Baseline (preoperatively) and 4 weeks post-operatively.
measure: Change in Scar Relative Depth
timeFrame: Baseline (preoperatively) and 4 weeks post-operatively
measure: Change in Scar Absolute Depth
timeFrame: Baseline (preoperatively) and 4 weeks post-operatively
measure: Vancouver Scar Scale (VSS)
timeFrame: Baseline (preoperatively) and at weeks 2 and 4.
measure: Patient Scar Assessment Scale (PSAS)
timeFrame: Baseline (preoperatively) and at weeks 2 and 4.
measure: Observer Scar Assessment Scale (OSAS)
timeFrame: Baseline (preoperatively), 2 weeks, and 4 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Alexander Meves, MD
role: PRINCIPAL_INVESTIGATOR
References: