Hypertrophic Scar Prevention by Novel Topical Gel Application

NCT03403621 | Terminated Phase 1 Results DMC FDA Drug

• 1 other identifier: 17-005230
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertrophic Scar

Outcome Measures

Primary Outcomes (1)

• Serious Adverse Events

  Number of participants to experience serious adverse events as defined as death \[due to treatment\] or life threatening adverse experience \[due to treatment\], hospitalization \[due to treatment\], persistent or significant disability or incapacity \[due to treatment\], birth defect/anomalies \[due to treatment\] and tissue necrosis \[due to treatment\].

  4 weeks post-operatively

Secondary Outcomes (10)

• Adverse Events

  4 weeks post-operatively

• Change in Scar Volume

  Baseline (pre-operatively) and at postop week 2 and 4.

• Change in Scar Fibrosis

  Baseline (preoperatively) and 4 weeks post-operatively.

• Change in Scar Sclerosis

  Baseline (preoperatively) and 4 weeks post-operatively.

• Change in Scar Angioplasia

  Baseline (preoperatively) and 4 weeks post-operatively.

Study Arms (2)

Topical Pentamidine Isethionate

EXPERIMENTAL

Subjects were randomly assigned to apply topical pentamidine isethionate to either the proximal or distal end of their incision every 48 hours for 4 weeks following surgical scar excision (14-16 treatments).

Drug: Pentamidine Isethionate

Placebo Control

PLACEBO COMPARATOR

Subjects were randomly assigned to apply topical placebo to either the proximal or distal end of their incision every 48 hours for 4 weeks following surgical scar excision (14-16 treatments). The subject served as their own control.

Drug: Placebo

Interventions

Pentamidine Isethionate DRUG

Approximately 1.8 mL single dose delivered as topical formulation containing 2% topical pentamidine in silicone-containing base.

Also known as: Pentamidine 2% cream

Topical Pentamidine Isethionate

Placebo DRUG

No active ingredient. Approximately 1.8 mL single dose delivered as topical silicone compounding base only.

Also known as: PCCA Pracasil™-Plus (PP)

Placebo Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Cicatrix, Hypertrophic

Interventions

Pentamidine

Condition Hierarchy (Ancestors)

Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzamidines; Amidines; Organic Chemicals

Limitations and Caveats

Terminated study due to funding changes.

Results Point of Contact

• Title: Dr. Alexander Meves
• Organization: Mayo Clinic

Meves.Alexander@mayo.edu

507-284-3668

Study Officials

• Alexander Meves, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Randomization will done by the Research Pharmacy
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: December 14, 2017
• First Posted: January 18, 2018
• Study Start: March 5, 2018
• Primary Completion: February 26, 2020
• Study Completion: February 26, 2020
• Last Updated: November 22, 2023
• Results First Posted: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)