N/A
N=37
Efficacy of 1540 Nanometer Erbium Glass Laser to Improve Benign Dermatofibromas
Dermatofibroma of Skin
Bottom Line
View on ClinicalTrials.gov: NCT03392935 ↗Enrolled (actual)
37
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcome: Primary: Modified Patient and Observer Scar Assessment Scale Color Component Comparing Change From Baseline to Week 12. — -2.33 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 1540 nanometer Erbium glass laser (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Utah
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Modified Patient and Observer Scar Assessment Scale Color Component Comparing Change From Baseline to Week 12. |
-2.33 | — |
| SECONDARY Modified Patient and Observer Scar Assessment Scale Itch Component Comparing Change From Baseline to Week 12. |
-0.25 | — |
| SECONDARY Modified Patient and Observer Scar Assessment Scale Texture Component Comparing Change From Baseline to Week 12. |
-2.92 | — |
| SECONDARY Modified Patient and Observer Scar Assessment Scale Pain Component Comparing Change From Baseline to Week 12. |
— | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- female or male, age 18-65, have at least one dermatofibroma of the skin, on the trunk or extremities, diagnosed by dermatologist, dermatofibroma is either itchy, painful or unattractive to the patient.
Exclusion Criteria
- previous treatment to the dermatofibroma(s), pregnant or nursing women, diabetic, smoker, psoriasis, lupus or other autoimmune diseases, patient with a clear history of keloids or poor wound healing. This study will exclude dermatofibroma lesions on the face and genitals.
Data sourced from ClinicalTrials.gov (NCT03392935). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.