Dermatofibroma of SkinNCT03392935
Efficacy of 1540 Nanometer Erbium Glass Laser to Improve Benign Dermatofibromas
A study testing 1540 nanometer Erbium glass laser in people with Dermatofibroma of Skin, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dermatofibroma of Skin
- What is being tested?
- 1540 nanometer Erbium glass laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2017to 31 Mar 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Dermatology
Salt Lake City, Utah, 84132
About this study
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.
Read the 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.
- Conditions
- Dermatofibroma of Skin
- Being tested
- 1540 nanometer Erbium glass laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1540 nanometer Erbium glass laserDevice
Subjects will receive laser treatment by dermatologist at week 0 and week 4.
| Study group | Role | What they receive |
|---|---|---|
| All Subjects | Experimental | 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. Receives: Device: 1540 nanometer Erbium glass laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Patient and Observer Scar Assessment Scale Color Component Comparing Change From Baseline to Week 12.
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).
Measured: 12 weeks
Secondary outcomes (3)
Modified Patient and Observer Scar Assessment Scale Itch Component Comparing Change From Baseline to Week 12.
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).
Measured: 12 Weeks
Modified Patient and Observer Scar Assessment Scale Texture Component Comparing Change From Baseline to Week 12.
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).
Measured: 12 Weeks
Modified Patient and Observer Scar Assessment Scale Pain Component Comparing Change From Baseline to Week 12.
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).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2018
- Study start30 Nov 2017
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dermatofibroma of SkinStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karen Stolman, MD, Principal investigator, Intermountain Health Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03392935
- Sponsor's protocol ID
- IRB_101842
- Status last verified
- Jun 2021
- First submitted
- 2 Jan 2018
- Last updated
- 8 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of 1540 Nanometer Erbium Glass Laser to Improve Benign Dermatofibromas
- ClinicalTrials.gov ID
- NCT03392935
- Acronym / sponsor ID
- IRB_101842
- Conditions
- Dermatofibroma of Skin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 30 Nov 2017 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 8 Jan 2018 (actual)
- Results
- Posted 23 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| All Subjects | Experimental | Device: 1540 nanometer Erbium glass laserAll 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1540 nanometer Erbium glass laserSubjects will receive laser treatment by dermatologist at week 0 and week 4. | Device | All Subjects |
Primary outcome
Modified Patient and Observer Scar Assessment Scale Color Component Comparing Change From Baseline to Week 12.
Time frame: 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).
3 secondary outcomes
Modified Patient and Observer Scar Assessment Scale Itch Component Comparing Change From Baseline to Week 12.
Time frame: 12 Weeks
Modified Patient and Observer Scar Assessment Scale Texture Component Comparing Change From Baseline to Week 12.
Time frame: 12 Weeks
Modified Patient and Observer Scar Assessment Scale Pain Component Comparing Change From Baseline to Week 12.
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Stolman, MD principal investigator
Intermountain Health Care, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1540 nanometer Erbium glass laser in people with Dermatofibroma of Skin, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Patient and Observer Scar Assessment Scale Color Component Comparing Change From Baseline to Week 12. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2023.