Hypertrophic Scar Prevention by Novel Topical Gel Application

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Males and females 18 years of age or older.
  • 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 ≥ 3 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 systemic corticosteroids (excludes inhaled or topical steroids), COX-2 inhibitors and/or drugs that are strong inhibitors and inducers of 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.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Alexander Meves, M.D., M.B.A.

Closed for enrollment

More information

Publications

Publications are currently not available

Additional contact information

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