Efficacy and Tolerability of a Fractional Ablative Erbium Laser for Axillary Scarring for Hidradenitis Suppurativa Patients
Study Details
Study Description
Brief Summary
Single center, randomized, open-label, baseline-controlled study evaluating the use of a Sciton fractionated ablative laser in the treatment of Hidradenitis Suppurativa (HS) scarring.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The investigators seek to observe the efficacy and tolerability in patients without active HS lesions. The study may enroll up to 10 subjects looking for improvement in their HS scarring in the axillary region. 10 subjects will receive treatment with the Sciton Joule erbium-YAG 2940nm laser along with treatment with topical tretinoin, hydroquinone, and hydrocortisone starting 1 month prior to first laser 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, hydroquinone, and hydrocortisone). Subjects will complete a DLQI survey, patient satisfaction survey, and clinical photographs at each treatment visit and at follow-up 1, 2, and 3 months after the last treatment. Two blinded dermatologists will perform clinical assessments comparing change in baseline scarring severity to images taken at the final follow up visit and assess using a modified scale for HS-scarring Severity.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Patients with scarring from HS lesions 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. |
Device: Sciton laser Joule X
Patients will be treated with the ablative laser.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Physician graded assessment [Month 0]
GAIS (Global Aesthetic Improvement Scale)- Using photographic assessments. Scored from -3 greatly worsened in scar severity to 3 greatly improved in scar severity. A score of zero represents no change.
- Physician graded assessment [Month 6]
GAIS (Global Aesthetic Improvement Scale)- using photographic assessments. Scored from -3 greatly worsened in scar severity to 3 greatly improved in scar severity. A score of zero represents no change.
- Modified Scale for HS Scar Severity: (mSHSS) [Month 0]
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) [Month 6]
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
- Physician graded assessment [Month 2]
GAIS (Global Aesthetic Improvement Scale)- Using photographic assessments. Scored from -3 greatly worsened in scar severity to 3 greatly improved in scar severity. A score of zero represents no change.
- Physician graded assessment [Month 3]
GAIS (Global Aesthetic Improvement Scale)- Using photographic assessments. Scored from -3 greatly worsened in scar severity to 3 greatly improved in scar severity. A score of zero represents no change.
- Physician graded assessment [Month 4]
GAIS (Global Aesthetic Improvement Scale)- Using photographic assessments. Scored from -3 greatly worsened in scar severity to 3 greatly improved in scar severity. A score of zero represents no change.
- Physician graded assessment [Month 5]
GAIS (Global Aesthetic Improvement Scale)- Using photographic assessments. Scored from -3 greatly worsened in scar severity to 3 greatly improved in scar severity. A score of zero represents no change.
Secondary Outcome Measures
- Subject Satisfaction [Month 1]
1. Please choose the option that better represents the change in how your skin looks OVERALL in the area treated? 2. Please choose the option that better represents the change in your scar texture in the area treated? 3. Please choose the option that better represents the change in your scarring in the area treated? 4. Please choose the option that better represents the change in your skin pigmentation in the area treated. • -3 = Greatly decreased • -2 = Moderately decreased • -1 = Slightly decreased • 0 = No change • 1 = Slightly increased • 2 = Moderately increased • 3 = Greatly increased 5. Beyond texture, pigmentation and overall HS-related scarring changes, did you notice any other changes in the area that was treated? 6. How would you characterize your satisfaction with the treatment? 7. Would you recommend the treatment to your friends and family members (check one)?
- Subject Satisfaction [month 2]
1. Please choose the option that better represents the change in how your skin looks OVERALL in the area treated? 2. Please choose the option that better represents the change in your scar texture in the area treated? 3. Please choose the option that better represents the change in your scarring in the area treated? 4. Please choose the option that better represents the change in your skin pigmentation in the area treated. • -3 = Greatly decreased • -2 = Moderately decreased • -1 = Slightly decreased • 0 = No change • 1 = Slightly increased • 2 = Moderately increased • 3 = Greatly increased 5. Beyond texture, pigmentation and overall HS-related scarring changes, did you notice any other changes in the area that was treated? 6. How would you characterize your satisfaction with the treatment? 7. Would you recommend the treatment to your friends and family members (check one)?
- Subject Satisfaction [month 3]
1. Please choose the option that better represents the change in how your skin looks OVERALL in the area treated? 2. Please choose the option that better represents the change in your scar texture in the area treated? 3. Please choose the option that better represents the change in your scarring in the area treated? 4. Please choose the option that better represents the change in your skin pigmentation in the area treated. • -3 = Greatly decreased • -2 = Moderately decreased • -1 = Slightly decreased • 0 = No change • 1 = Slightly increased • 2 = Moderately increased • 3 = Greatly increased 5. Beyond texture, pigmentation and overall HS-related scarring changes, did you notice any other changes in the area that was treated? 6. How would you characterize your satisfaction with the treatment? 7. Would you recommend the treatment to your friends and family members (check one)?
- Subject Satisfaction [month 4]
1. Please choose the option that better represents the change in how your skin looks OVERALL in the area treated? 2. Please choose the option that better represents the change in your scar texture in the area treated? 3. Please choose the option that better represents the change in your scarring in the area treated? 4. Please choose the option that better represents the change in your skin pigmentation in the area treated. • -3 = Greatly decreased • -2 = Moderately decreased • -1 = Slightly decreased • 0 = No change • 1 = Slightly increased • 2 = Moderately increased • 3 = Greatly increased 5. Beyond texture, pigmentation and overall HS-related scarring changes, did you notice any other changes in the area that was treated? 6. How would you characterize your satisfaction with the treatment? 7. Would you recommend the treatment to your friends and family members (check one)?
- Subject Satisfaction [month 5]
1. Please choose the option that better represents the change in how your skin looks OVERALL in the area treated? 2. Please choose the option that better represents the change in your scar texture in the area treated? 3. Please choose the option that better represents the change in your scarring in the area treated? 4. Please choose the option that better represents the change in your skin pigmentation in the area treated. • -3 = Greatly decreased • -2 = Moderately decreased • -1 = Slightly decreased • 0 = No change • 1 = Slightly increased • 2 = Moderately increased • 3 = Greatly increased 5. Beyond texture, pigmentation and overall HS-related scarring changes, did you notice any other changes in the area that was treated? 6. How would you characterize your satisfaction with the treatment? 7. Would you recommend the treatment to your friends and family members (check one)?
- Subject Satisfaction [month 6]
1. Please choose the option that better represents the change in how your skin looks OVERALL in the area treated? 2. Please choose the option that better represents the change in your scar texture in the area treated? 3. Please choose the option that better represents the change in your scarring in the area treated? 4. Please choose the option that better represents the change in your skin pigmentation in the area treated. • -3 = Greatly decreased • -2 = Moderately decreased • -1 = Slightly decreased • 0 = No change • 1 = Slightly increased • 2 = Moderately increased • 3 = Greatly increased 5. Beyond texture, pigmentation and overall HS-related scarring changes, did you notice any other changes in the area that was treated? 6. How would you characterize your satisfaction with the treatment? 7. Would you recommend the treatment to your friends and family members (check one)?
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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Subjects must voluntarily sign and date an IRB approved informed consent form.
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Subjects with diagnosis of HS scarring recorded over the past 6 months.
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Subject has an HS PGA Scale of 0 or 1
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Able to read, understand and voluntarily provide written informed consent.
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Subjects are determined to be healthy, non-smokers.
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Subjects able and willing to comply with the treatment protocol and follow-up schedule and requirements.
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Understand and accept the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
Exclusion Criteria:
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Subject does not have the capacity to consent to the study.
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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.
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Any history of keloid scarring.
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Any previous surgical procedure in the treatment area in the past 12 months, or major surgery in the last 6 months.
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History of immunosuppression/immune deficiency disorders (including AIDS and HIV infection), and/or any history of systemic chemotherapy for prior 12 months.
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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.
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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
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Smoking or vaping in the past 12 months.
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History of an allergy or an adverse reaction to hydroquinone or tretinoin.
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History of photosensitivity and/or connective tissue disease.
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History of uncontrolled diabetes, hypertension and depression.
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History of ongoing pregnancy, active breastfeeding, cancer, and epilepsy.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Montefiore Medical Center
Investigators
- Principal Investigator: Kseniya Kobets, MD, Albert Einstein College of Medicine/ Montefiore Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022-14262