Clinical trial NCT03392935: Efficacy of 1540 Nanometer Erbium Glass Laser to Improve Benign Dermatofibromas
Official title: Efficacy of 1540 Nanometer Erbium Glass Laser to Improve Benign Dermatofibromas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dermatofibroma of Skin
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2018-01-08
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

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.

Primary outcomes:
measure: Modified Patient and Observer Scar Assessment Scale Color Component Comparing Change From Baseline to Week 12.
timeFrame: 12 weeks
Secondary outcomes:
measure: Modified Patient and Observer Scar Assessment Scale Itch Component Comparing Change From Baseline to Week 12.
timeFrame: 12 Weeks
measure: Modified Patient and Observer Scar Assessment Scale Texture Component Comparing Change From Baseline to Week 12.
timeFrame: 12 Weeks
measure: Modified Patient and Observer Scar Assessment Scale Pain Component Comparing Change From Baseline to Week 12.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah Dermatology
state: Utah
Study officials:
affiliation: Intermountain Health Care, Inc.
name: Karen Stolman, MD
role: PRINCIPAL_INVESTIGATOR
References: