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Trial record 21 of 64 for:    Soft Tissue | "Dermatofibroma"

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
Sponsor:
Information provided by (Responsible Party):
Karen Stolman, 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.

Condition or disease Intervention/treatment Phase
Dermatofibroma of Skin Device: 1540 nanometer Erbium glass laser Not Applicable

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 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.
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear
Drug Information available for: Erbium

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
Contact: Karen Stolman, MD 8015816465 karen.stolman@hsc.utah.edu
Contact: Adrianne Evans 8012130375 adrianne.evans@hsc.utah.edu

Locations
United States, Utah
University of Utah Dermatology Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Karen Stolman, MD    801-581-6465    karen.stolman@hsc.utah.edu   
Principal Investigator: Karen Stolman, MD         
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Adrianne Evans, MD University of Utah Dermatology

Responsible Party: Karen Stolman, Principal Investigator, University of Utah
ClinicalTrials.gov Identifier: NCT03392935     History of Changes
Other Study ID Numbers: IRB_101842
First Posted: January 8, 2018    Key Record Dates
Last Update Posted: January 8, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Histiocytoma, Benign Fibrous
Histiocytoma
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Methamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors