Ensayos clínicos

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.