An interventional study of 1540 nanometer Erbium glass laser in Dermatofibroma of Skin, sponsored by University of Utah. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-05-08.
Sponsored by University of Utah · Not applicable, Interventional, and Treatment
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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.
4 studies on the registry are indexed under Histiocytoma, Benign Fibrous; 1 is open to participants now.
Browse Histiocytoma, Benign Fibrous studies →University of Utah is the lead sponsor of 996 studies on the registry; 176 are open to participants now.
Of its 114 completed or terminated interventional studies of FDA-regulated products, 69 (61%) have results posted.
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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.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: 1540 nanometer Erbium glass laser
Subjects will receive laser treatment by dermatologist at week 0 and week 4.
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).
Time frame: 12 weeks
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).
Time frame: 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).
Time frame: 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).
Time frame: 12 weeks
| Milestone | All Subjects |
|---|---|
| Started | 37 |
| Completed | 35 |
| Not completed | 2 |
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).
| score on a scale | All Subjects |
|---|---|
| Modified Patient and Observer Scar Assessment Scale Color Component Comparing Change From Baseline to Week 12. | -2.33 ± 2.33 |
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).
| score on a scale | All Subjects |
|---|---|
| Modified Patient and Observer Scar Assessment Scale Itch Component Comparing Change From Baseline to Week 12. | -0.25 ± 1.03 |
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).
| score on a scale | All Subjects |
|---|---|
| Modified Patient and Observer Scar Assessment Scale Texture Component Comparing Change From Baseline to Week 12. | -2.92 ± 2.89 |
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).
| score on a scale | All Subjects |
|---|---|
| Modified Patient and Observer Scar Assessment Scale Pain Component Comparing Change From Baseline to Week 12. | 0 ± 0.42 |
Collected over Adverse events were collected from baseline to week 12.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Subjects | 0/37 (0%) | 0/37 (0%) | 37/37 (100%) |
| Event | All Subjects |
|---|---|
| Transient ErythemaSkin and subcutaneous tissue disorders | 37/37 |
| Transient EdemaSkin and subcutaneous tissue disorders | 37/37 |
| Age, Categorical(Participants) | All Subjects |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 37 |
| >=65 years | 0 |
| Age, Continuous(years) | All Subjects |
|---|---|
| Mean | 43.8 ± 10.8 |
| Sex: Female, Male(Participants) | All Subjects |
|---|---|
| Female | 32 |
| Male | 5 |
| Race and Ethnicity Not Collected(Participants) | All Subjects |
|---|
| Region of Enrollment(participants) | All Subjects |
|---|---|
| United States | 37 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Nov 2017 to primary completion in Mar 2021, 40 months.
Results were first posted in Jun 2021, 2 months after primary completion.
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