Trial Outcomes & Findings for Efficacy of 1540 Nanometer Erbium Glass Laser to Improve Benign Dermatofibromas (NCT NCT03392935)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

37 participants

Primary outcome timeframe

12 weeks

Results posted on

2023-05-08

Participant Flow

Unit of analysis: lesions

Participant milestones

Participant milestones
Measure	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. 1540 nanometer Erbium glass laser: Subjects will receive laser treatment by dermatologist at week 0 and week 4.
Overall Study STARTED	37 46
Overall Study COMPLETED	35 44
Overall Study NOT COMPLETED	2 2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy of 1540 Nanometer Erbium Glass Laser to Improve Benign Dermatofibromas

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Subjects n=46 Lesions 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. 1540 nanometer Erbium glass laser: Subjects will receive laser treatment by dermatologist at week 0 and week 4.
Age, Categorical <=18 years	0 Participants n=37 Participants
Age, Categorical Between 18 and 65 years	37 Participants n=37 Participants
Age, Categorical >=65 years	0 Participants n=37 Participants
Age, Continuous	43.8 years STANDARD_DEVIATION 10.8 • n=37 Participants
Sex: Female, Male Female	32 Participants n=37 Participants
Sex: Female, Male Male	5 Participants n=37 Participants
Region of Enrollment United States	37 participants n=37 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	All Subjects n=44 lesions 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. 1540 nanometer Erbium glass laser: Subjects will receive laser treatment by dermatologist at week 0 and week 4.
Modified Patient and Observer Scar Assessment Scale Color Component Comparing Change From Baseline to Week 12.	-2.33 score on a scale Standard Deviation 2.33

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	All Subjects n=44 lesion 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. 1540 nanometer Erbium glass laser: Subjects will receive laser treatment by dermatologist at week 0 and week 4.
Modified Patient and Observer Scar Assessment Scale Itch Component Comparing Change From Baseline to Week 12.	-0.25 score on a scale Standard Deviation 1.03

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	All Subjects n=44 lesions 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. 1540 nanometer Erbium glass laser: Subjects will receive laser treatment by dermatologist at week 0 and week 4.
Modified Patient and Observer Scar Assessment Scale Texture Component Comparing Change From Baseline to Week 12.	-2.92 score on a scale Standard Deviation 2.89

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	All Subjects n=44 lesions 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. 1540 nanometer Erbium glass laser: Subjects will receive laser treatment by dermatologist at week 0 and week 4.
Modified Patient and Observer Scar Assessment Scale Pain Component Comparing Change From Baseline to Week 12.	0 score on a scale Standard Deviation 0.42

Adverse Events

All Subjects

Serious events: 0 serious events

Other events: 37 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	All Subjects n=37 participants at risk 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. 1540 nanometer Erbium glass laser: Subjects will receive laser treatment by dermatologist at week 0 and week 4.
Skin and subcutaneous tissue disorders Transient Erythema	100.0% 37/37 • Number of events 87 • Adverse events were collected from baseline to week 12.
Skin and subcutaneous tissue disorders Transient Edema	100.0% 37/37 • Number of events 87 • Adverse events were collected from baseline to week 12.

Additional Information

Dr. Karen Stolman, Assistant Professor, Dermatology

University of Utah Dermatology

Phone: 8015816465

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place