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Funding changes.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pentamidine Isethionate | Drug | Approximately 1.8 mL single dose delivered as topical formulation containing 2% topical pentamidine in silicone-containing base. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Alexander Meves, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Topical Pentamidine Isethionate | 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). Pentamidine Isethionate: Approximately 1.8 mL single dose delivered as topical formulation containing 2% topical pentamidine in silicone-containing base. |
| FG001 | Placebo Control | 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. Placebo: No active ingredient. Approximately 1.8 mL single dose delivered as topical silicone compounding base only. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | All study participants received two treatments: topical pentamidine isethionate and placebo. Participants were randomly assigned to apply topical pentamidine isethionate to either the proximal or distal end of their incision and placebo on the other end of their incision every 48 hours for 4 weeks following surgical scar excision (14-16 treatments). Pentamidine Isethionate: Approximately 1.8 mL single dose delivered as topical formulation containing 2% topical pentamidine in silicone-containing base. Placebo: No active ingredient. Approximately 1.8 mL single dose delivered as topical silicone compounding base only. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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]. | Posted | Count of Participants | Participants | 4 weeks post-operatively |
|
Adverse events were collected from baseline to end of study participation for a total of approximately 3 months on all participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Topical Pentamidine Isethionate | 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). Pentamidine Isethionate: Approximately 1.8 mL single dose delivered as topical formulation containing 2% topical pentamidine in silicone-containing base. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin Itching | Skin and subcutaneous tissue disorders | Systematic Assessment |
Terminated study due to funding changes.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alexander Meves | Mayo Clinic | 507-284-3668 | Meves.Alexander@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 25, 2019 | Oct 10, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D017439 | Cicatrix, Hypertrophic |
| ID | Term |
|---|---|
| D002921 | Cicatrix |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D010419 | Pentamidine |
| ID | Term |
|---|---|
| D001550 | Benzamidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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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.
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Randomization will done by the Research Pharmacy
|
| Placebo | Drug | No active ingredient. Approximately 1.8 mL single dose delivered as topical silicone compounding base only. |
|
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| 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. | 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) | 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) | 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) | 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) | 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) | 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. | 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). | 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). | Baseline (preoperatively), 2 weeks, and 4 weeks |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| OG001 |
| Placebo Control |
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. Placebo: No active ingredient. Approximately 1.8 mL single dose delivered as topical silicone compounding base only. |
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 4 weeks post-operatively |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | cm^3 | Baseline (pre-operatively) and at postop week 2 and 4. |
|
|
|
| Secondary | 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) | Posted | Median | Full Range | units on a scale | Baseline (preoperatively) and 4 weeks post-operatively. |
|
|
|
| Secondary | 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) | Posted | Median | Full Range | units on a scale | Baseline (preoperatively) and 4 weeks post-operatively. |
|
|
|
| Secondary | 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) | Posted | Median | Full Range | units on a scale | Baseline (preoperatively) and 4 weeks post-operatively. |
|
|
|
| Secondary | 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) | Posted | Median | Full Range | units on a scale | Baseline (preoperatively) and 4 weeks post-operatively |
|
|
|
| Secondary | Change in Scar Absolute Depth | Measurement of scar absolute depth on skin punch biopsy reporting in millimeters (mm) | Posted | Mean | Standard Deviation | millimeters | Baseline (preoperatively) and 4 weeks post-operatively |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline (preoperatively) and at weeks 2 and 4. |
|
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | score on a scale | Baseline (preoperatively) and at weeks 2 and 4. |
|
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | score on a scale | Baseline (preoperatively), 2 weeks, and 4 weeks |
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|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 4 |
| 6 |
| EG001 | Placebo Control | 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. Placebo: No active ingredient. Approximately 1.8 mL single dose delivered as topical silicone compounding base only. | 0 | 6 | 0 | 6 | 5 | 6 |
| Skin flaking | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Pustules | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Localized pain | General disorders | Systematic Assessment |
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| Bruising | General disorders | Systematic Assessment |
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| Wound dehiscence | Surgical and medical procedures | Systematic Assessment |
|
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| 4 weeks |
|
| Superiority |
| Baseline versus 2 weeks | t-test, 2 sided | 0.51 | Superiority |
| Baseline versus 4 weeks | t-test, 2 sided | 0.58 | Superiority |
| 4 weeks |
|
| Superiority |
| Baseline versus 2 weeks | t-test, 2 sided | 0.02 | Superiority |
| Baseline versus 4 weeks | t-test, 2 sided | 0.007 | Superiority |
| 4 weeks |
|
| Superiority |
| Baseline versus 2 weeks | t-test, 2 sided | 0.33 | Superiority |
| Baseline versus 4 weeks | t-test, 2 sided | 0.5 | Superiority |