Back to resultsEfficacy and Tolerability of a Fractional Ablative Erbium Laser for Axillary Scarring for Hidradenitis Suppurativa Patients
Primary Purpose
Hidradenitis Suppurativa, Scarring
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Er: YAG laser
Sponsored by
About this trial
This is an interventional treatment trial for Hidradenitis Suppurativa
Eligibility Criteria
Inclusion Criteria:
- Healthy males and females, ≥ 18 years of age at time of informed consent with no upper age limit, seeking treatment for HS scarring in the axillary region.
- Subjects must voluntarily sign and date an IRB approved informed consent form.
- Subjects with diagnosis of HS (Hidradenitis Suppurativa) scarring recorded over the past 6 months.
- Subject has an HS PGA (Hidradenitis Suppurativa Physician's Global Assessment) Scale of 0 or 1
- Able to read, understand and voluntarily provide written informed consent.
- Subjects are determined to be healthy, non-smokers.
- Subjects able and willing to comply with the treatment protocol and follow-up schedule and requirements.
- Understand and accept the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
Exclusion Criteria:
- Subject does not have the capacity to consent to the study.
- Subject underwent any medical-grade scar treatments (ie, lasers, excision procedures, topical prescriptions for scars) in the past 6 months prior to enrollment in the study.
- Any history of keloid scarring.
- Any previous surgical procedure in the treatment area in the past 12 months, or major surgery in the last 6 months.
- History of immunosuppression/immune deficiency disorders (including AIDS and HIV infection), and/or any history of systemic chemotherapy for prior 12 months.
- Subject has no health contraindications to receiving local lidocaine and epinephrine injections, including but not limited to any form of heart disease or arrhythmia, untreated or uncontrolled severe hypertension, uncontrolled hyperthyroidism, uncontrolled diabetes, pheochromocytoma, Cocaine use.
- History or current use of the following prescription medications:Accutane or other systemic retinoids within the past twelve months, Tricyclic antidepressant, monoamine oxidase inhibitors, B-blocker
- Smoking or vaping in the past 12 months.
- History of an allergy or an adverse reaction to hydroquinone or tretinoin.
- History of photosensitivity and/or connective tissue disease.
- History of uncontrolled diabetes, hypertension and depression.
- History of ongoing pregnancy, active breastfeeding, cancer, and epilepsy.
Sites / Locations
- Montefiore Einstein Advanced CareRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Laser Treatment
Arm Description
The parameters of the laser will be set according to optimal operation protocol and in accordance with guidelines set forth by Sciton. Each laser treatment will take approximately 10 to 15 minutes per subject to target HS scarring.
Outcomes
Primary Outcome Measures
Modified Scale for HS Scar Severity (mSHSS)
HS Scar Severity will be assessed in participants using mSHSS as follows:
Clear - 0 - No visible scars from HS Almost Clear -1 - Hardly visible from 2.5 m away Mild - 2-Easily recognizable; less than half the affected area Moderate - 3 - More than half the affected area involved Severe - 4 - Entire area involved Very Severe - 5 - Entire area with prominent atrophic or hypertrophic scars
Modified Scale for HS Scar Severity (mSHSS)
HS Scar Severity will be assessed in participants using mSHSS as follows:
Clear - 0 - No visible scars from HS Almost Clear -1 - Hardly visible from 2.5 m away Mild - 2-Easily recognizable; less than half the affected area Moderate - 3 - More than half the affected area involved Severe - 4 - Entire area involved Very Severe - 5 - Entire area with prominent atrophic or hypertrophic scars
Secondary Outcome Measures
Subject Satisfaction Survey
Following treatment participants will be asked to complete a survey in the clinic while referring to their image in a mirror and comparing post-treatment photos versus baseline photos. Scoring will be assessed as follows (-3 = Greatly decreased, -2 = Moderately decreased, -1 = Slightly decreased, 0 = No change, 1 = Slightly increased, 2 = Moderately increased, 3 = Greatly increased) with a lower overall score denoting improvement in appearance.
Subject Satisfaction Survey
Following treatment participants will be asked to complete a survey in the clinic while referring to their image in a mirror and comparing post-treatment photos versus baseline photos. Scoring will be assessed as follows (-3 = Greatly decreased, -2 = Moderately decreased, -1 = Slightly decreased, 0 = No change, 1 = Slightly increased, 2 = Moderately increased, 3 = Greatly increased) with a lower overall score denoting improvement in appearance.
Subject Satisfaction Survey
Following treatment participants will be asked to complete a survey in the clinic while referring to their image in a mirror and comparing post-treatment photos versus baseline photos. Scoring will be assessed as follows (-3 = Greatly decreased, -2 = Moderately decreased, -1 = Slightly decreased, 0 = No change, 1 = Slightly increased, 2 = Moderately increased, 3 = Greatly increased) with a lower overall score denoting improvement in appearance.
Subject Satisfaction Survey
Participants will be asked to complete a survey in the clinic while referring to their image in a mirror and comparing post-treatment photos versus baseline photos. Scoring will be assessed as follows (-3 = Greatly decreased, -2 = Moderately decreased, -1 = Slightly decreased, 0 = No change, 1 = Slightly increased, 2 = Moderately increased, 3 = Greatly increased) with a lower overall score denoting improvement in appearance.
Subject Satisfaction Survey
Participants will be asked to complete a survey in the clinic while referring to their image in a mirror and comparing post-treatment photos versus baseline photos. Scoring will be assessed as follows (-3 = Greatly decreased, -2 = Moderately decreased, -1 = Slightly decreased, 0 = No change, 1 = Slightly increased, 2 = Moderately increased, 3 = Greatly increased) with a lower overall score denoting improvement in appearance.
Subject Satisfaction Survey
Participants will be asked to complete a survey in the clinic while referring to their image in a mirror and comparing post-treatment photos versus baseline photos. Scoring will be assessed as follows (-3 = Greatly decreased, -2 = Moderately decreased, -1 = Slightly decreased, 0 = No change, 1 = Slightly increased, 2 = Moderately increased, 3 = Greatly increased) with a lower overall score denoting improvement in appearance.
Physician graded assessment of scar severity
Scar severity will be assessed in participants by way of GAIS (Global Aesthetic Improvement Scale) using photographic assessments. Scoring will range from -3 (greatly worsened scar severity) to 3 (greatly improved scar severity). A score of zero represents no change in scar severity.
Physician graded assessment of hyperpigmentation
Hyperpigmentation will be assessed in participants by way of GAIS (Global Aesthetic Improvement Scale) using photographic assessments. Scoring will range from -3 (greatly worsened hyperpigmentation) to 3 (greatly improved hyperpigmentation). A score of zero represents no change in hyperpigmentation.
Physician graded assessment of scar severity
Scar severity will be assessed in participants by way of GAIS (Global Aesthetic Improvement Scale) using photographic assessments. Scoring will range from -3 (greatly worsened scar severity) to 3 (greatly improved scar severity). A score of zero represents no change in scar severity.
Physician graded assessment of hyperpigmentation
Hyperpigmentation will be assessed in participants by way of GAIS (Global Aesthetic Improvement Scale) using photographic assessments. Scoring will range from -3 (greatly worsened hyperpigmentation) to 3 (greatly improved hyperpigmentation). A score of zero represents no change in hyperpigmentation.
Physician graded assessment of scar severity
Scar severity will be assessed in participants by way of GAIS (Global Aesthetic Improvement Scale) using photographic assessments. Scoring will range from -3 (greatly worsened scar severity) to 3 (greatly improved scar severity). A score of zero represents no change in scar severity.
Physician graded assessment of hyperpigmentation
Hyperpigmentation will be assessed in participants by way of GAIS (Global Aesthetic Improvement Scale) using photographic assessments. Scoring will range from -3 (greatly worsened hyperpigmentation) to 3 (greatly improved hyperpigmentation). A score of zero represents no change in hyperpigmentation.
Physician graded assessment of scar severity
Scar severity will be assessed in participants by way of GAIS (Global Aesthetic Improvement Scale) using photographic assessments. Scoring will range from -3 (greatly worsened scar severity) to 3 (greatly improved scar severity). A score of zero represents no change in scar severity.
Physician graded assessment of hyperpigmentation
Hyperpigmentation will be assessed in participants by way of GAIS (Global Aesthetic Improvement Scale) using photographic assessments. Scoring will range from -3 (greatly worsened hyperpigmentation) to 3 (greatly improved hyperpigmentation). A score of zero represents no change in hyperpigmentation.
Physician graded assessment of scar severity
Scar severity will be assessed in participants by way of GAIS (Global Aesthetic Improvement Scale) using photographic assessments. Scoring will range from -3 (greatly worsened scar severity) to 3 (greatly improved scar severity). A score of zero represents no change in scar severity.
Physician graded assessment of hyperpigmentation
Hyperpigmentation will be assessed in participants by way of GAIS (Global Aesthetic Improvement Scale) using photographic assessments. Scoring will range from -3 (greatly worsened hyperpigmentation) to 3 (greatly improved hyperpigmentation). A score of zero represents no change in hyperpigmentation.
Physician graded assessment of hyperpigmentation
Hyperpigmentation will be assessed in participants by way of GAIS (Global Aesthetic Improvement Scale) using photographic assessments. Scoring will range from -3 (greatly worsened hyperpigmentation) to 3 (greatly improved hyperpigmentation). A score of zero represents no change in hyperpigmentation.
Physician graded assessment of scar severity
Scar severity will be assessed in participants by way of GAIS (Global Aesthetic Improvement Scale) using photographic assessments. Scoring will range from -3 (greatly worsened scar severity) to 3 (greatly improved scar severity). A score of zero represents no change in scar severity.
Full Information
NCT ID
NCT05470322
First Posted
July 20, 2022
Last Updated
October 10, 2023
Sponsor
Montefiore Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05470322
Brief Title
Efficacy and Tolerability of a Fractional Ablative Erbium Laser for Axillary Scarring for Hidradenitis Suppurativa Patients
Official Title
Efficacy and Tolerability of a Fractional Ablative Erbium Laser for Axillary Scarring for Hidradenitis Suppurativa Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Montefiore Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Single center, open-label, baseline-controlled study evaluating the use of a Sciton fractionated ablative laser in the treatment of Hidradenitis Suppurativa (HS) scarring.
Detailed Description
Single center, open-label, baseline-controlled study evaluating the use of a Sciton fractionated ablative laser in the treatment of Hidradenitis Suppurativa (HS) scarring. The device is FDA approved for the treatment of scarring in all skin types. The study team seeks to observe the efficacy and tolerability in patients without active HS lesions. The study may enroll up to 19 subjects looking for improvement in their HS scarring in the axillary region. The subjects will receive treatment with the Sciton Joule Er:YAG 2940nm laser along with treatment with topical tretinoin, hydroquinone, and hydrocortisone starting 1 month prior to first laser treatment as per standard of care for scar treatment. Each patient will receive 3 treatments spaced approximately one month apart. The patients will be surveyed about their quality of life due to HS scarring, as well as their perspectives on their axillary scarring before and after their assigned treatments. All patients included in the study will have no contraindications to either laser or the use of standard treatment protocol (tretinoin and hydroquinone). Subjects in the laser group will complete a DLQI (Dermatology Life Quality Index) survey, patient satisfaction survey, and clinical photographs at each treatment visit and at follow-up 1, 2, and 3 months after the last treatment. Subjects in the topical treatment group will be evaluated at the initial visit, month 3 and month 6.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hidradenitis Suppurativa, Scarring
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
No masking will be performed.
Allocation
N/A
Enrollment
19 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Laser Treatment
Arm Type
Experimental
Arm Description
The parameters of the laser will be set according to optimal operation protocol and in accordance with guidelines set forth by Sciton. Each laser treatment will take approximately 10 to 15 minutes per subject to target HS scarring.
Intervention Type
Device
Intervention Name(s)
Er: YAG laser
Other Intervention Name(s)
laser, fractional ablative laser
Intervention Description
Patients will be treated with laser for their HS scarring.
Primary Outcome Measure Information:
Title
Modified Scale for HS Scar Severity (mSHSS)
Description
HS Scar Severity will be assessed in participants using mSHSS as follows:
Clear - 0 - No visible scars from HS Almost Clear -1 - Hardly visible from 2.5 m away Mild - 2-Easily recognizable; less than half the affected area Moderate - 3 - More than half the affected area involved Severe - 4 - Entire area involved Very Severe - 5 - Entire area with prominent atrophic or hypertrophic scars
Time Frame
Month 0
Title
Modified Scale for HS Scar Severity (mSHSS)
Description
HS Scar Severity will be assessed in participants using mSHSS as follows:
Clear - 0 - No visible scars from HS Almost Clear -1 - Hardly visible from 2.5 m away Mild - 2-Easily recognizable; less than half the affected area Moderate - 3 - More than half the affected area involved Severe - 4 - Entire area involved Very Severe - 5 - Entire area with prominent atrophic or hypertrophic scars
Time Frame
Month 6
Secondary Outcome Measure Information:
Title
Subject Satisfaction Survey
Description
Following treatment participants will be asked to complete a survey in the clinic while referring to their image in a mirror and comparing post-treatment photos versus baseline photos. Scoring will be assessed as follows (-3 = Greatly decreased, -2 = Moderately decreased, -1 = Slightly decreased, 0 = No change, 1 = Slightly increased, 2 = Moderately increased, 3 = Greatly increased) with a lower overall score denoting improvement in appearance.
Time Frame
Month 1
Title
Subject Satisfaction Survey
Description
Following treatment participants will be asked to complete a survey in the clinic while referring to their image in a mirror and comparing post-treatment photos versus baseline photos. Scoring will be assessed as follows (-3 = Greatly decreased, -2 = Moderately decreased, -1 = Slightly decreased, 0 = No change, 1 = Slightly increased, 2 = Moderately increased, 3 = Greatly increased) with a lower overall score denoting improvement in appearance.
Time Frame
Month 2
Title
Subject Satisfaction Survey
Description
Following treatment participants will be asked to complete a survey in the clinic while referring to their image in a mirror and comparing post-treatment photos versus baseline photos. Scoring will be assessed as follows (-3 = Greatly decreased, -2 = Moderately decreased, -1 = Slightly decreased, 0 = No change, 1 = Slightly increased, 2 = Moderately increased, 3 = Greatly increased) with a lower overall score denoting improvement in appearance.
Time Frame
Month 3
Title
Subject Satisfaction Survey
Description
Participants will be asked to complete a survey in the clinic while referring to their image in a mirror and comparing post-treatment photos versus baseline photos. Scoring will be assessed as follows (-3 = Greatly decreased, -2 = Moderately decreased, -1 = Slightly decreased, 0 = No change, 1 = Slightly increased, 2 = Moderately increased, 3 = Greatly increased) with a lower overall score denoting improvement in appearance.
Time Frame
Month 4
Title
Subject Satisfaction Survey
Description
Participants will be asked to complete a survey in the clinic while referring to their image in a mirror and comparing post-treatment photos versus baseline photos. Scoring will be assessed as follows (-3 = Greatly decreased, -2 = Moderately decreased, -1 = Slightly decreased, 0 = No change, 1 = Slightly increased, 2 = Moderately increased, 3 = Greatly increased) with a lower overall score denoting improvement in appearance.
Time Frame
Month 5
Title
Subject Satisfaction Survey
Description
Participants will be asked to complete a survey in the clinic while referring to their image in a mirror and comparing post-treatment photos versus baseline photos. Scoring will be assessed as follows (-3 = Greatly decreased, -2 = Moderately decreased, -1 = Slightly decreased, 0 = No change, 1 = Slightly increased, 2 = Moderately increased, 3 = Greatly increased) with a lower overall score denoting improvement in appearance.
Time Frame
Month 6
Title
Physician graded assessment of scar severity
Description
Scar severity will be assessed in participants by way of GAIS (Global Aesthetic Improvement Scale) using photographic assessments. Scoring will range from -3 (greatly worsened scar severity) to 3 (greatly improved scar severity). A score of zero represents no change in scar severity.
Time Frame
Month 0
Title
Physician graded assessment of hyperpigmentation
Description
Hyperpigmentation will be assessed in participants by way of GAIS (Global Aesthetic Improvement Scale) using photographic assessments. Scoring will range from -3 (greatly worsened hyperpigmentation) to 3 (greatly improved hyperpigmentation). A score of zero represents no change in hyperpigmentation.
Time Frame
Month 0
Title
Physician graded assessment of scar severity
Description
Scar severity will be assessed in participants by way of GAIS (Global Aesthetic Improvement Scale) using photographic assessments. Scoring will range from -3 (greatly worsened scar severity) to 3 (greatly improved scar severity). A score of zero represents no change in scar severity.
Time Frame
Month 2
Title
Physician graded assessment of hyperpigmentation
Description
Hyperpigmentation will be assessed in participants by way of GAIS (Global Aesthetic Improvement Scale) using photographic assessments. Scoring will range from -3 (greatly worsened hyperpigmentation) to 3 (greatly improved hyperpigmentation). A score of zero represents no change in hyperpigmentation.
Time Frame
Month 2
Title
Physician graded assessment of scar severity
Description
Scar severity will be assessed in participants by way of GAIS (Global Aesthetic Improvement Scale) using photographic assessments. Scoring will range from -3 (greatly worsened scar severity) to 3 (greatly improved scar severity). A score of zero represents no change in scar severity.
Time Frame
Month 3
Title
Physician graded assessment of hyperpigmentation
Description
Hyperpigmentation will be assessed in participants by way of GAIS (Global Aesthetic Improvement Scale) using photographic assessments. Scoring will range from -3 (greatly worsened hyperpigmentation) to 3 (greatly improved hyperpigmentation). A score of zero represents no change in hyperpigmentation.
Time Frame
Month 3
Title
Physician graded assessment of scar severity
Description
Scar severity will be assessed in participants by way of GAIS (Global Aesthetic Improvement Scale) using photographic assessments. Scoring will range from -3 (greatly worsened scar severity) to 3 (greatly improved scar severity). A score of zero represents no change in scar severity.
Time Frame
Month 4
Title
Physician graded assessment of hyperpigmentation
Description
Hyperpigmentation will be assessed in participants by way of GAIS (Global Aesthetic Improvement Scale) using photographic assessments. Scoring will range from -3 (greatly worsened hyperpigmentation) to 3 (greatly improved hyperpigmentation). A score of zero represents no change in hyperpigmentation.
Time Frame
Month 4
Title
Physician graded assessment of scar severity
Description
Scar severity will be assessed in participants by way of GAIS (Global Aesthetic Improvement Scale) using photographic assessments. Scoring will range from -3 (greatly worsened scar severity) to 3 (greatly improved scar severity). A score of zero represents no change in scar severity.
Time Frame
Month 5
Title
Physician graded assessment of hyperpigmentation
Description
Hyperpigmentation will be assessed in participants by way of GAIS (Global Aesthetic Improvement Scale) using photographic assessments. Scoring will range from -3 (greatly worsened hyperpigmentation) to 3 (greatly improved hyperpigmentation). A score of zero represents no change in hyperpigmentation.
Time Frame
Month 5
Title
Physician graded assessment of hyperpigmentation
Description
Hyperpigmentation will be assessed in participants by way of GAIS (Global Aesthetic Improvement Scale) using photographic assessments. Scoring will range from -3 (greatly worsened hyperpigmentation) to 3 (greatly improved hyperpigmentation). A score of zero represents no change in hyperpigmentation.
Time Frame
Month 6
Title
Physician graded assessment of scar severity
Description
Scar severity will be assessed in participants by way of GAIS (Global Aesthetic Improvement Scale) using photographic assessments. Scoring will range from -3 (greatly worsened scar severity) to 3 (greatly improved scar severity). A score of zero represents no change in scar severity.
Time Frame
Month 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy males and females, ≥ 18 years of age at time of informed consent with no upper age limit, seeking treatment for HS scarring in the axillary region.
Subjects must voluntarily sign and date an IRB approved informed consent form.
Subjects with diagnosis of HS (Hidradenitis Suppurativa) scarring recorded over the past 6 months.
Subject has an HS PGA (Hidradenitis Suppurativa Physician's Global Assessment) Scale of 0 or 1
Able to read, understand and voluntarily provide written informed consent.
Subjects are determined to be healthy, non-smokers.
Subjects able and willing to comply with the treatment protocol and follow-up schedule and requirements.
Understand and accept the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
Exclusion Criteria:
Subject does not have the capacity to consent to the study.
Subject underwent any medical-grade scar treatments (ie, lasers, excision procedures, topical prescriptions for scars) in the past 6 months prior to enrollment in the study.
Any history of keloid scarring.
Any previous surgical procedure in the treatment area in the past 12 months, or major surgery in the last 6 months.
History of immunosuppression/immune deficiency disorders (including AIDS and HIV infection), and/or any history of systemic chemotherapy for prior 12 months.
Subject has no health contraindications to receiving local lidocaine and epinephrine injections, including but not limited to any form of heart disease or arrhythmia, untreated or uncontrolled severe hypertension, uncontrolled hyperthyroidism, uncontrolled diabetes, pheochromocytoma, Cocaine use.
History or current use of the following prescription medications:Accutane or other systemic retinoids within the past twelve months, Tricyclic antidepressant, monoamine oxidase inhibitors, B-blocker
Smoking or vaping in the past 12 months.
History of an allergy or an adverse reaction to hydroquinone or tretinoin.
History of photosensitivity and/or connective tissue disease.
History of uncontrolled diabetes, hypertension and depression.
History of ongoing pregnancy, active breastfeeding, cancer, and epilepsy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hailey Konisky, BS
Phone
518-596-4306
Email
hailey.konisky@einsteinmed.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Zahi Islam
Email
zislam@montefoire.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kseniya Kobets, MD
Organizational Affiliation
Albert Einstein College of Medicine Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Einstein Advanced Care
City
Elmsford
State/Province
New York
ZIP/Postal Code
10523
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hailey Konisky, BS
Email
hailey.konisky@einsteinmed.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy and Tolerability of a Fractional Ablative Erbium Laser for Axillary Scarring for Hidradenitis Suppurativa Patients
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