Efficacy of 1540 Nanometer Erbium Glass Laser to Improve Benign Dermatofibromas
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|ClinicalTrials.gov Identifier: NCT03392935|
Recruitment Status : Recruiting
First Posted : January 8, 2018
Last Update Posted : January 8, 2018
|Condition or disease||Intervention/treatment||Phase|
|Dermatofibroma of Skin||Device: 1540 nanometer Erbium glass laser||Not Applicable|
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 rated by blinded reviewers after the study to determine efficacy.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|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 to determine efficacy.|
|Masking:||None (Open Label)|
|Masking Description:||Outcome assessors are masked and will not know which photos are pre-treatment or post treatment, 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.|
|Official Title:||Efficacy of 1540 Nanometer Erbium Glass Laser to Improve Benign Dermatofibromas|
|Actual Study Start Date :||November 30, 2017|
|Estimated Primary Completion Date :||November 2018|
|Estimated Study Completion Date :||November 2019|
Experimental: 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.
Device: 1540 nanometer Erbium glass laser
Subjects will receive laser treatment by dermatologist at week 0 and week 4.
- Efficacy of 1540 nanometer Erbium glass laser on Dermatofibromas [ Time Frame: Blinded assessors will review after all 20 subjects have completed the study (approximately 18 months after first patient enrollment) ]Efficacy will be measured by blinded dermatologist assessors by rating collor and texture of dermatofibromas. They will be blinded to which photos are pre-treatment vs. post-treatment
- Patient satisfaction with treatment for dermatofibromas by 1540 nanometer Erbium glass laser [ Time Frame: Subjects will answer questionnaires at each visit from start of study to completion. Outcome measures will be reviewed when all subjects have completed the study (approximately 18 months after first patient enrollment) ]Patient satisfaction will be measured by patient ratings in questionnaire by subjects rating their pain, itch, color, and texture of their dermatofibromas pre-treatment vs. post-treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03392935
|Contact: Karen Stolman, MDfirstname.lastname@example.org|
|Contact: Adrianne Evansemail@example.com|
|United States, Utah|
|University of Utah Dermatology||Recruiting|
|Salt Lake City, Utah, United States, 84132|
|Contact: Karen Stolman, MD 801-581-6465 firstname.lastname@example.org|
|Principal Investigator: Karen Stolman, MD|
|Principal Investigator:||Adrianne Evans, MD||University of Utah Dermatology|