Efficacy of 1540 Nanometer Erbium Glass Laser to Improve Benign Dermatofibromas

Not Applicable

Completed

• Conditions: Dermatofibroma of Skin
• Interventions: Device: 1540 nanometer Erbium glass laser

• Registration Number: NCT03392935
• Lead Sponsor: University of Utah

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.

Study Timeline

• Study Start: 2017-11-30
• Study First Submitted: 2018-01-02
• Study First Submitted QC: 2018-01-02
• Study First Posted: 2018-01-08
• Primary Completion: 2021-03-31
• Study Completion: 2021-03-31
• Results First Submitted: 2021-04-30
• Status Verified: 2021-06
• Results First Submitted QC: 2021-06-01
• Results First Posted: 2021-06-23
• Last Update Submitted: 2023-05-04
• Last Update Posted: 2023-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All Subjects	1540 nanometer Erbium glass laser	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.

Primary Outcome Measures

Name	Time	Method
Modified Patient and Observer Scar Assessment Scale Color Component Comparing Change From Baseline to Week 12.	12 weeks	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).

Secondary Outcome Measures

Name	Time	Method
Modified Patient and Observer Scar Assessment Scale Itch Component Comparing Change From Baseline to Week 12.	12 Weeks	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).
Modified Patient and Observer Scar Assessment Scale Texture Component Comparing Change From Baseline to Week 12.	12 Weeks	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).
Modified Patient and Observer Scar Assessment Scale Pain Component Comparing Change From Baseline to Week 12.	12 weeks	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).

Trial Locations

Locations (1)

University of Utah Dermatology; 🇺🇸 Salt Lake City, Utah, United States