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Hypertrophic ScarPhase 1/2NCT03403621

Hypertrophic Scar Prevention by Novel Topical Gel Application

A Phase 1/2 study testing Pentamidine Isethionate in people with Hypertrophic Scar, run by Mayo Clinic at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypertrophic Scar
What is being tested?
Pentamidine Isethionate
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
6 participants
Where
1 siteUnited States
Study dates
5 Mar 2018to 26 Feb 2020
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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.
Show all 14Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Pentamidine Isethionate, Placebo
Medical subject headings
Cicatrix, Hypertrophic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pentamidine IsethionateDrug

    Also called Pentamidine 2% cream

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

  • PlaceboDrug

    Also called PCCA Pracasil™-Plus (PP)

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

Study groups in NCT03403621
Study groupRoleWhat they receive
Topical Pentamidine IsethionateExperimentalSubjects 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).
Receives: Drug: Pentamidine Isethionate
Placebo ControlPlacebo comparatorSubjects 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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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].

    Measured: 4 weeks post-operatively

Secondary outcomes (10)

  1. Adverse Events

    Number of participants to experience adverse events as defined as skin infection, skin irritation and wound dehiscence. Skin irritation is scored by local skin reaction (LSR) grading scale. Wound infection is defined by skin that is red, swollen, hot and painful ("calor, dolor, rubor, tumor") [by clinical exam] with or without discharge. Wound dehiscence is defined as a measurable breaking open of the surgical incision along the suture.

    Measured: 4 weeks post-operatively

  2. Change in Scar Volume

    Ultrasound will be used to quantify hypertrophic scar dimensions (length, width and height) and volume size using cm^3 as the unit of measure.

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

  3. Change in Scar Fibrosis

    Semi-quantitative assessment of scar fibrosis on skin punch biopsy using a scale of none(1) - mild(2) - moderate(3) - severe(4)

    Measured: Baseline (preoperatively) and 4 weeks post-operatively.

  4. Change in Scar Sclerosis

    Semi-quantitative assessment of scar sclerosis on skin punch biopsy using a scale of none(1) - mild(2) - moderate(3) - severe(4)

    Measured: Baseline (preoperatively) and 4 weeks post-operatively.

  5. Change in Scar Angioplasia

    Semi-quantitative assessment of scar angioplasia on skin punch biopsy using a scale of none(1) - mild(2) - moderate(3) - severe(4)

    Measured: Baseline (preoperatively) and 4 weeks post-operatively.

  6. Change in Scar Relative Depth

    Semi-quantitative assessment of scar relative depth on skin punch biopsy using a scale of Epidermis(1) - Mid-Reticular Dermis (2) - Deep Dermis(3) - Fat(4)

    Measured: Baseline (preoperatively) and 4 weeks post-operatively

  7. Change in Scar Absolute Depth

    Measurement of scar absolute depth on skin punch biopsy reporting in millimeters (mm)

    Measured: Baseline (preoperatively) and 4 weeks post-operatively

  8. Vancouver Scar Scale (VSS)

    The VSS assesses 4 variables: vascularity, height/thickness, pliability, and pigmentation. Scale ranges are as follows. Pigmentation (0=normal, 1=hypopigmentation, 2=hyperpigmentation). Height (0=flat, 1=less than 2 mm, 2=2 to 5 mm, 3=greater than 5 mm). Vascularity (0=normal, 1=pink, 2=red, 3=purple). Pliability (0=normal, 1=supple, 2=yielding, 3=firm, 4=banding,5=contracture). Total score can range from 0 to 13, with 0=normal skin, and 13=severe scarring.

    Measured: Baseline (preoperatively) and at weeks 2 and 4.

  9. Patient Scar Assessment Scale (PSAS)

    The patient scar scale assesses pain, itching, color, stiffness, thickness, and irregularity. The scale rates each variable on a scale from 1 (normal skin) to 10 (worst scar imaginable), with a total possible score ranging from 1 (normal) to 120 (worst scar imaginable).

    Measured: Baseline (preoperatively) and at weeks 2 and 4.

  10. Observer Scar Assessment Scale (OSAS)

    The observer scar assessment scale assesses vascularity, pigmentation, thickness, relief, pliability, and surface area. The scale rates each variable on a scale from 1 (normal skin) to 10 (worst scar imaginable), with a total possible score ranging from 1 (normal) to 120 (worst scar imaginable).

    Measured: Baseline (preoperatively), 2 weeks, and 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2018
  2. Study start5 Mar 2018
  3. Primary completion26 Feb 2020
  4. Study completion26 Feb 2020

Why it stopped: Funding changes.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03403621
Sponsor's protocol ID
17-005230
Status last verified
Nov 2023
First submitted
14 Dec 2017
Last updated
22 Nov 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Pentamidine Isethionate in people with Hypertrophic Scar, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serious Adverse Events (time frame: 4 weeks post-operatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03403621.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023; AzTrials last refreshed its copy on 2 Nov 2026.

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