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No patients were able to consented/enrolled into the study during the period of time the study was approved by the IRB. Study officially withdrawn with the IRB on 11/24/2025.
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Single center, open-label, baseline-controlled study evaluating the use of a Sciton fractionated ablative laser in the treatment of Hidradenitis Suppurativa (HS) scarring.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laser Treatment | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Er: YAG laser | Device | Patients will be treated with laser for their HS scarring. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Month 0 |
| 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 | Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kseniya Kobets, MD | Albert Einstein College of Medicine Montefiore Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Einstein Advanced Care | Elmsford | New York | 10523 | United States |
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| ID | Term |
|---|---|
| D017497 | Hidradenitis Suppurativa |
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D017192 | Skin Diseases, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D053844 | Lasers, Solid-State |
| D007834 | Lasers |
| ID | Term |
|---|---|
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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No masking will be performed.
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| Month 1 |
| 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. | Month 2 |
| 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. | Month 3 |
| 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. | Month 4 |
| 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. | Month 5 |
| 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. | Month 6 |
| 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. | Month 0 |
| 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. | Month 0 |
| 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. | Month 2 |
| 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. | Month 2 |
| 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. | Month 3 |
| 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. | Month 3 |
| 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. | Month 4 |
| 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. | Month 4 |
| 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. | Month 5 |
| 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. | Month 5 |
| 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. | Month 6 |
| 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. | Month 6 |
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D016575 | Hidradenitis |
| D013543 | Sweat Gland Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |