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This study is to find a more effective treatment for itchy, painful or unsightly dermatofibromas, that will improve symptoms of itch and/or pain and/or improve the appearance of dermatofibromas. This is an open-label study where subjects will receive a laser treatment at week 0, and week 4, and then 2 additional follow-up visits. Photographs will be taken at each visit and rated by blinded reviewers after the study to determine efficacy.
The main objective of this study is to find a more effective treatment for itchy, painful or unsightly dermatofibromas, that will improve symptoms of itch and/or pain and/or improve the appearance of dermatofibromas. A secondary objective of this study is to better understand the 1540 nanometer Erbium glass laser and its impact on the skin.
This is an open-label study where subjects will receive a laser treatment at week 0, and week 4, and then have 2 additional follow-up visits (no laser treatment at these visits). Photographs will be taken at each visit and photographs from pre-treatment and follow-up 1 (week 8) will rated by blinded reviewers after the study to determine efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Subjects | Experimental | All subjects will be treated with the laser at week 0 and week 4. Only assessors will be blinded and rate the dermatofibromas in photographs, they will not know which photos were taken pre-treatment vs. post-treatment to determine efficacy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1540 nanometer Erbium glass laser | Device | Subjects will receive laser treatment by dermatologist at week 0 and week 4. |
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| Measure | Description | Time Frame |
|---|---|---|
| Modified Patient and Observer Scar Assessment Scale Color Component Comparing Change From Baseline to Week 12. | Patient reported assessment scale of pain, itch, color, and texture. Each element (pain, itch, color, and texture) is graded on a 1-10 scale. The lowest score is '1', which corresponds to the situation of normal skin/no symptoms (i.e. not different in color, not different in texture, no itching, no pain). Score 10 equals the largest difference from normal skin (i.e. severely painful, severely itchy, vert different color, very different texture). | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Patient and Observer Scar Assessment Scale Itch Component Comparing Change From Baseline to Week 12. | Patient reported assessment scale of pain, itch, color, and texture. Each element (pain, itch, color, and texture) is graded on a 1-10 scale. The lowest score is '1', which corresponds to the situation of normal skin/no symptoms (i.e. not different in color, not different in texture, no itching, no pain). Score 10 equals the largest difference from normal skin (i.e. severely painful, severely itchy, vert different color, very different texture). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen Stolman, MD | Intermountain Health Care, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah Dermatology | Salt Lake City | Utah | 84132 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Subjects | All subjects will be treated with the laser at week 0 and week 4. Only assessors will be blinded and rate the dermatofibromas in photographs, they will not know which photos were taken pre-treatment vs. post-treatment to determine efficacy. 1540 nanometer Erbium glass laser: Subjects will receive laser treatment by dermatologist at week 0 and week 4. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | All subjects will be treated with the laser at week 0 and week 4. Only assessors will be blinded and rate the dermatofibromas in photographs, they will not know which photos were taken pre-treatment vs. post-treatment to determine efficacy. 1540 nanometer Erbium glass laser: Subjects will receive laser treatment by dermatologist at week 0 and week 4. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Modified Patient and Observer Scar Assessment Scale Color Component Comparing Change From Baseline to Week 12. | Patient reported assessment scale of pain, itch, color, and texture. Each element (pain, itch, color, and texture) is graded on a 1-10 scale. The lowest score is '1', which corresponds to the situation of normal skin/no symptoms (i.e. not different in color, not different in texture, no itching, no pain). Score 10 equals the largest difference from normal skin (i.e. severely painful, severely itchy, vert different color, very different texture). | Posted | Mean | Standard Deviation | score on a scale | 12 weeks | lesions | lesions |
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Adverse events were collected from baseline to week 12.
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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 | All Subjects | All subjects will be treated with the laser at week 0 and week 4. Only assessors will be blinded and rate the dermatofibromas in photographs, they will not know which photos were taken pre-treatment vs. post-treatment to determine efficacy. 1540 nanometer Erbium glass laser: Subjects will receive laser treatment by dermatologist at week 0 and week 4. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Transient Erythema | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Transient expected redness at the site of laser applicaiton, resolving within 3 days of treatment without sequela. . |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Karen Stolman, Assistant Professor, Dermatology | University of Utah Dermatology | 8015816465 | ks@checkmateproductions.com |
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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 | May 17, 2018 | May 24, 2021 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 22, 2018 | Apr 28, 2021 | ICF_001.pdf |
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All subjects will have their dermatofibromas treated with the laser at week 0, and week 4. Blinded outcome assessors will rate photos (pre-treatment and follow-up visit 1) to determine efficacy.
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Outcome assessors are masked and will not know which photos are pre-treatment or follow-up visit 1, however, they do know that all subjects received treatment at some point. They will rate the dermatofibromas to determine efficacy. However, there is only one arm of this study. All patients are receiving the same treatment. Outcomes assessors are the only masked roles.
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| 12 Weeks |
| Modified Patient and Observer Scar Assessment Scale Texture Component Comparing Change From Baseline to Week 12. | Patient reported assessment scale of pain, itch, color, and texture. Each element (pain, itch, color, and texture) is graded on a 1-10 scale. The lowest score is '1', which corresponds to the situation of normal skin/no symptoms (i.e. not different in color, not different in texture, no itching, no pain). Score 10 equals the largest difference from normal skin (i.e. severely painful, severely itchy, vert different color, very different texture). | 12 Weeks |
| Modified Patient and Observer Scar Assessment Scale Pain Component Comparing Change From Baseline to Week 12. | Patient reported assessment scale of pain, itch, color, and texture. Each element (pain, itch, color, and texture) is graded on a 1-10 scale. The lowest score is '1', which corresponds to the situation of normal skin/no symptoms (i.e. not different in color, not different in texture, no itching, no pain). Score 10 equals the largest difference from normal skin (i.e. severely painful, severely itchy, vert different color, very different texture). | 12 weeks |
| Lesions |
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| Participants |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years | Participants |
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| Sex: Female, Male | Count of Participants | Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
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| Region of Enrollment | Number | participants | Participants |
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| Secondary | Modified Patient and Observer Scar Assessment Scale Itch Component Comparing Change From Baseline to Week 12. | Patient reported assessment scale of pain, itch, color, and texture. Each element (pain, itch, color, and texture) is graded on a 1-10 scale. The lowest score is '1', which corresponds to the situation of normal skin/no symptoms (i.e. not different in color, not different in texture, no itching, no pain). Score 10 equals the largest difference from normal skin (i.e. severely painful, severely itchy, vert different color, very different texture). | Posted | Mean | Standard Deviation | score on a scale | 12 Weeks | lesion | lesion |
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| Secondary | Modified Patient and Observer Scar Assessment Scale Texture Component Comparing Change From Baseline to Week 12. | Patient reported assessment scale of pain, itch, color, and texture. Each element (pain, itch, color, and texture) is graded on a 1-10 scale. The lowest score is '1', which corresponds to the situation of normal skin/no symptoms (i.e. not different in color, not different in texture, no itching, no pain). Score 10 equals the largest difference from normal skin (i.e. severely painful, severely itchy, vert different color, very different texture). | Posted | Mean | Standard Deviation | score on a scale | 12 Weeks | lesions | lesions |
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| Secondary | Modified Patient and Observer Scar Assessment Scale Pain Component Comparing Change From Baseline to Week 12. | Patient reported assessment scale of pain, itch, color, and texture. Each element (pain, itch, color, and texture) is graded on a 1-10 scale. The lowest score is '1', which corresponds to the situation of normal skin/no symptoms (i.e. not different in color, not different in texture, no itching, no pain). Score 10 equals the largest difference from normal skin (i.e. severely painful, severely itchy, vert different color, very different texture). | Posted | Mean | Standard Deviation | score on a scale | 12 weeks | lesions | lesions |
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| 37 |
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| 37 |
| 37 |
| 37 |
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| Transient Edema | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Transient expected swelling at site of laser application, resolving within 3 days of treatment without sequela. |
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