A Phase 1/2 interventional study of Pentamidine Isethionate and Placebo in Hypertrophic Scar, sponsored by Mayo Clinic. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-22.
Sponsored by Mayo Clinic · Phase 1/2, Interventional, and Prevention
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Among 38 studies in Cicatrix, Hypertrophic with a site in United States — 7 open to participants now, 8 under way, 2 of them phase 3. Cicatrix, Hypertrophic · United States.
Among the 38 studies in Cicatrix, Hypertrophic with a site in United States, this one is the 30th largest by enrollment of the 35 interventional ones that give a count, is one of 3 that started in 2018, is one of 2 in phase 1/2, and was the 17th registered.
129 studies on the registry are indexed under Cicatrix, Hypertrophic; 31 are open to participants now.
Browse Cicatrix, Hypertrophic studies →7 of the 38 studies in Cicatrix, Hypertrophic with a site in United States are open now. Recruiting first, the newest first:
Sonal Choudhary · Sites in United States
Ages 18+
Medical University of South Carolina · Sites in United States
Ages 18+
Iran University of Medical Sciences · Sites in United States, Iran, Islamic Republic of
Ages 20–60
Medstar Health Research Institute · Sites in United States
Ages 18+
Melissa Pugliano-Mauro · Sites in United States
Ages 18+ · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 19 Cicatrix, Hypertrophic studies recruiting now, 8 (42%) set no upper age limit and 10 (53%) stop at 75 or younger; 1 takes children under 18; 5 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
38 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 15 · Phase 3 3 · Phase 4 3
First in 2006; this study’s year is marked. 3 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 6 is below the median of 36 across 106 interventional studies indexed under Cicatrix, Hypertrophic.
Median enrollment 22 across the 35 interventional studies, 1,000 across the 3 observational. Of the 22 that completed or were terminated, 11 (50%) have results posted.
This tab as a report to print or save as PDF → With an account.
11 of 38 have an industry lead sponsor. The 10 most frequent:
Mayo Clinic is the lead sponsor of 3,271 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
Mayo Clinic has 1 study filed under Cicatrix, Hypertrophic — fewer than ten, so there is no comparison to draw.
4 of the studies in Cicatrix, Hypertrophic with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05478551Phase 3Henry Ford Health SystemRandomized Controlled Trial Examining the Efficacy of Botulinum Toxin in Biopsy Scar Minimization | 2026-12-30 |
| NCT07336368Phase 3Sonal ChoudharyTopical Cryotherapy and Keloid/Hypertrophic Scars | 2027-06 |
| NCT07213544Medical University of South CarolinaRemimazolam vs Propofol in Laser Burn Cases | 2027-01-01 |
| NCT03561376Melissa Pugliano-MauroZinc Oxide Versus Petrolatum Following Skin Surgery | 2027-09-30 |
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Among the 38 studies in Cicatrix, Hypertrophic with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subject with a hypertrophic scar that meet all of the following criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Approximately 1.8 mL single dose delivered as topical formulation containing 2% topical pentamidine in silicone-containing base.
Also known as: Pentamidine 2% cream
No active ingredient. Approximately 1.8 mL single dose delivered as topical silicone compounding base only.
Also known as: PCCA Pracasil™-Plus (PP)
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 \[due to treatment\].
Time frame: 4 weeks post-operatively
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.
Time frame: 4 weeks post-operatively
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.
Time frame: Baseline (pre-operatively) and at postop week 2 and 4.
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)
Time frame: Baseline (preoperatively) and 4 weeks post-operatively.
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)
Time frame: Baseline (preoperatively) and 4 weeks post-operatively.
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)
Time frame: Baseline (preoperatively) and 4 weeks post-operatively.
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)
Time frame: Baseline (preoperatively) and 4 weeks post-operatively
Change in Scar Absolute Depth
Measurement of scar absolute depth on skin punch biopsy reporting in millimeters (mm)
Time frame: Baseline (preoperatively) and 4 weeks post-operatively
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.
Time frame: Baseline (preoperatively) and at weeks 2 and 4.
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).
Time frame: Baseline (preoperatively) and at weeks 2 and 4.
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).
Time frame: Baseline (preoperatively), 2 weeks, and 4 weeks
| Milestone | Topical Pentamidine Isethionate | Placebo Control |
|---|---|---|
| Started | 6 | 6 |
| Completed | 4 | 4 |
| Not completed | 2 | 2 |
| Withdrew: Withdrawal by subject | 2 | 2 |
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 \[due to treatment\].
| Participants | Topical Pentamidine Isethionate | Placebo Control |
|---|---|---|
| Serious Adverse Events | 0 | 0 |
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.
| Participants | Topical Pentamidine Isethionate | Placebo Control |
|---|---|---|
| Adverse Events | 4 | 5 |
Ultrasound will be used to quantify hypertrophic scar dimensions (length, width and height) and volume size using cm\^3 as the unit of measure.
| cm^3 | Topical Pentamidine Isethionate | Placebo Control |
|---|---|---|
| Baseline, 2 weeks post-operative | -0.72 ± 0.50 | -0.68 ± 0.52 |
| Baseline, 4 weeks post-operative | -0.65 ± 0.77 | -0.76 ± 0.52 |
Semi-quantitative assessment of scar fibrosis on skin punch biopsy using a scale of none(1) - mild(2) - moderate(3) - severe(4)
| units on a scale | Topical Pentamidine Isethionate | Placebo Control |
|---|---|---|
| Change in Scar Fibrosis | 1 (1 to 2) | 2 (1 to 2) |
Semi-quantitative assessment of scar sclerosis on skin punch biopsy using a scale of none(1) - mild(2) - moderate(3) - severe(4)
| units on a scale | Topical Pentamidine Isethionate | Placebo Control |
|---|---|---|
| Change in Scar Sclerosis | 0 (0 to 2) | 0 (0 to 0) |
Semi-quantitative assessment of scar angioplasia on skin punch biopsy using a scale of none(1) - mild(2) - moderate(3) - severe(4)
| units on a scale | Topical Pentamidine Isethionate | Placebo Control |
|---|---|---|
| Change in Scar Angioplasia | 0 (-1 to 1) | 0 (-1 to 1) |
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)
| units on a scale | Topical Pentamidine Isethionate | Placebo Control |
|---|---|---|
| Change in Scar Relative Depth | 0 (-1 to 1) | 0 (-1 to 2) |
Measurement of scar absolute depth on skin punch biopsy reporting in millimeters (mm)
| millimeters | Topical Pentamidine Isethionate | Placebo Control |
|---|---|---|
| Change in Scar Absolute Depth | -0.17 ± 2.26 | 1.34 ± 2.09 |
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.
| score on a scale | Topical Pentamidine Isethionate | Placebo Control |
|---|---|---|
| Baseline | 5.5 ± 3.7 | 4.8 ± 3.6 |
| 2 weeks | 4.0 ± 2.2 | 3.5 ± 3.2 |
| 4 weeks | 4.8 ± 2.3 | 5.8 ± 2.2 |
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).
| score on a scale | Topical Pentamidine Isethionate | Placebo Control |
|---|---|---|
| Baseline | 39 ± 8.3 | 43.2 ± 9.1 |
| 2 weeks | 27.7 ± 6.6 | 28.7 ± 8.9 |
| 4 weeks | 25.5 ± 14.8 | 27.0 ± 11.9 |
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).
| score on a scale | Topical Pentamidine Isethionate | Placebo Control |
|---|---|---|
| Baseline | 32.3 ± 12.8 | 31.2 ± 13.7 |
| 2 weeks | 23.5 ± 10.1 | 23.3 ± 13.0 |
| 4 weeks | 23.2 ± 8.6 | 26.3 ± 9.9 |
Collected over Adverse events were collected from baseline to end of study participation for a total of approximately 3 months on all participants.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Topical Pentamidine Isethionate | 0/6 (0%) | 0/6 (0%) | 4/6 (66.7%) |
| Placebo Control | 0/6 (0%) | 0/6 (0%) | 5/6 (83.3%) |
| Event | Topical Pentamidine Isethionate | Placebo Control |
|---|---|---|
| Skin ItchingSkin and subcutaneous tissue disorders | 2/6 | 4/6 |
| Skin flakingSkin and subcutaneous tissue disorders | 2/6 | 2/6 |
| PustulesSkin and subcutaneous tissue disorders | 1/6 | 2/6 |
| DermatitisSkin and subcutaneous tissue disorders | 1/6 | 1/6 |
| Localized painGeneral disorders | 0/6 | 1/6 |
| BruisingGeneral disorders | 1/6 | 0/6 |
| Wound dehiscenceSurgical and medical procedures | 1/6 | 0/6 |
| Age, Continuous(years) | All Study Participants |
|---|---|
| Mean | 35 ± 15.94 |
| Sex: Female, Male(Participants) | All Study Participants |
|---|---|
| Female | 5 |
| Male | 1 |
| Ethnicity (NIH/OMB)(Participants) | All Study Participants |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 6 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | All Study Participants |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 6 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | All Study Participants |
|---|---|
| United States | 6 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Mar 2018 to primary completion in Feb 2020, 23 months.
Results were first posted in Nov 2023, 3 years 8 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Pentamidine