Hypertrophic Scar Clinical Trial
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
Verified date | November 2023 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 6 |
Est. completion date | February 26, 2020 |
Est. primary completion date | February 26, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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: - 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. 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 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. |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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]. | 4 weeks post-operatively | |
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. | 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. | 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) | 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) | 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) | 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) | 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) | 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. | 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). | 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). | Baseline (preoperatively), 2 weeks, and 4 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03376620 -
Role of Topical Putrescine (Fibrostat) for Prevention of Hypertrophic Scars in Mammoplasty Patients
|
Phase 3 | |
Terminated |
NCT03935594 -
Use of Autologous Platelet-Rich Plasma to Treat Hypertrophic Burn Scars
|
Phase 2 | |
Recruiting |
NCT03561376 -
Zinc Oxide Versus Petrolatum Following Skin Surgery
|
Early Phase 1 | |
Recruiting |
NCT06033430 -
Effectiveness of Dry Needling in Linear Scar Tissue
|
N/A | |
Recruiting |
NCT03631368 -
Treatment of Hypertrophic Scars With Intradermal Botox
|
Phase 2 | |
Completed |
NCT03630198 -
Pain Outcomes Following Intralesional Corticosteroid Injections
|
Phase 4 | |
Recruiting |
NCT02168634 -
The Use of Botulinum Toxin in the Treatment of Itching From Hypertrophic Scar -- A Randomised Controlled Trial
|
N/A | |
Completed |
NCT02030275 -
A Study to Evaluate the Effectiveness and Safety of RXI 109 on the Outcome of Scar Revision Surgery in Healthy Adults
|
Phase 2 | |
Recruiting |
NCT04506255 -
Silicone Taping for the Improvement of Abdominal Donor Site Scars
|
N/A | |
Not yet recruiting |
NCT04593706 -
Comparison of the Efficacy of Different Steroids in the Treatment of Abnormal Scars (Keloids, Hypertrophic Scars)
|
N/A | |
Completed |
NCT04643223 -
Effect of Elastic Bandage With Tension on the Inflammatory Response of Hypertrophic Scars
|
N/A | |
Completed |
NCT03986346 -
The Vascularity Changes of Scars With Laser Therapy
|
N/A | |
Completed |
NCT04619589 -
Characterization of Dyschromic Hypertrophic Scar
|
||
Completed |
NCT05412745 -
Class I Medical Device on Post-surgical Scars
|
N/A | |
Completed |
NCT06347081 -
Effect of Nd-YAG Laser on Hypertrophic Scar
|
N/A | |
Completed |
NCT00754247 -
A Randomized Comparative Study Evaluating the Tolerability and Efficacy of Two Topical Therapies for the Treatment of Keloids and Hypertrophic Scars
|
Phase 4 | |
Recruiting |
NCT03692273 -
Randomized Control Trial of CO2 Laser to Treat Hypertrophic Burn Scar
|
N/A | |
Completed |
NCT03795116 -
Light Emitting Diode-Red Light (LED-RL) Phototherapy for Skin Scarring Prevention
|
Phase 2 | |
Not yet recruiting |
NCT03850119 -
Nanofat on Wound Healing and Scar Formation
|
N/A | |
Recruiting |
NCT04364217 -
Pain and Itch Reduction in Burn Scars Treated With Fractional CO2 Laser
|
N/A |