Back to resultsEfficacy and Tolerability of a Hybrid Fractional Laser for the Treatment of Acne Scars in Patients With Skin of Color
Primary Purpose
Acne Scars - Mixed Atrophic and Hypertrophic, Hyperpigmentation, Laser-Induced Hyperpigmentation
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sciton Halo
Sponsored by
About this trial
This is an interventional treatment trial for Acne Scars - Mixed Atrophic and Hypertrophic focused on measuring skin of color, fitzpatrick skin type III, fitzpatrick skin type IV, fitzpatrick skin type V, acne scarring, sciton
Eligibility Criteria
Inclusion Criteria:
- Healthy males and females, ≥ 18 years of age at time of informed consent, seeking treatment for acne scarring
- Subject must be Fitzpatrick skin type III-VI
- Subject must voluntarily sign and date an IRB approved informed consent form
- Subjects with diagnosis of acne scarring recorded over the past 6 months
- Able to read, understand and voluntarily provide written informed consent.
- Subject is determined to be healthy, non-smoker
- Subjects able and willing to comply with the treatment protocol and follow-up schedule and requirements.
- Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
Exclusion Criteria:
- Subjects does not have the capacity to consent to the study
- subject underwent any acne scar treatments in the past 6 months prior to enrollment in the study
- Subject has active papulopustular or cystic acne within the past 6 months.
- Any history of keloidal 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.
- History or current use of the following prescription medications:
Immunosuppressive medications/biologics, 6 months prior to and during the study
- Accutane or other systemic retinoids within the past twelve months
- Smoking or vaping in the past 12 months.
- History of photosensitivity and/or connective tissue disease
- History of hyperlipidemia, diabetes mellitus, hepatitis, or bleeding disorders.
- History of major depressive disorders or endocrine disorders including but not limited to; hypothyroidism, Hashimoto's thyroiditis, or hyperthyroidism.
- History of ongoing pregnancy, active breastfeeding, cancer, and epilepsy
Sites / Locations
- 555 Taxter RoadRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Hybrid Fractional laser - SOC
Hybrid Fractional laser- Non- SOC
Arm Description
23 participants with fitzpatrick skin type IV-V will be in this arm. At the first visit, participants will undergo informed consent, education about the procedure, education about proper sun-care, and will be provided sunscreen. Participants will be prescribed a prescription of hydroquinone or a retinol to prevent hyperpigmentation, per standard of care. If participants choose to take this they will wait one month of taking the prescription and then begin treatment sessions. If not, participants can begin treatment sessions right away. Treatment consists of 3 laser sessions with the Sciton Halo hybrid fractional laser. Session amount depends on the degree of improvement. At each session before and after images will be collected. At each session participants will fill out the dermatology quality of life survey as well as a patient satisfaction survey.
23 participants with Fitzpatrick skin type I-III will be in this arm. At the first visit, participants will undergo informed consent, education about the procedure, education about proper sun-care, and will be provided sunscreen. Participants will be prescribed a prescription of hydroquinone or a retinol to prevent hyperpigmentation, per standard of care. If participants choose to take this they will wait one month of taking the prescription and then begin treatment sessions. If not, participants can begin treatment sessions right away. Treatment consists of 3 laser sessions with the Sciton Halo hybrid fractional laser. Session amount depends on the degree of improvement. At each session before and after images will be collected. At each session participants will fill out the dermatology quality of life survey as well as a patient satisfaction survey.
Outcomes
Primary Outcome Measures
Change from baseline acne scar severity
2 Independent unbiased blinded dermatologists will rate before and after treatment images using Global Scale for Acne Scarring. This scale is rated on a scale of 0 to 5. 0 is the least severe, and 5 is the most severe.
Change from baseline acne scar severity
2 Independent unbiased blinded dermatologists will rate before and after treatment images using Global Scale for Acne Scarring. This scale is rated on a scale of 0 to 5. 0 is the least severe, and 5 is the most severe.
Change from baseline acne scar severity
2 Independent unbiased blinded dermatologists will rate before and after treatment images using Global Scale for Acne Scarring. This scale is rated on a scale of 0 to 5. 0 is the least severe, and 5 is the most severe.
Baseline Patient Satisfaction
Patient Satisfaction Questionnaire. Questions are on a scale of -3 to 3, with -3 meaning the condition greatly decreased, and 3 meaning the condition greatly increased.
Patient Satisfaction
Patient Satisfaction Questionnaire. Questions are on a scale of -3 to 3, with -3 meaning the condition greatly decreased, and 3 meaning the condition greatly increased.
Patient Satisfaction
Patient Satisfaction Questionnaire. Questions are on a scale of -3 to 3, with -3 meaning the condition greatly decreased, and 3 meaning the condition greatly increased.
Patient Satisfaction
Patient Satisfaction Questionnaire. Questions are on a scale of -3 to 3, with -3 meaning the condition greatly decreased, and 3 meaning the condition greatly increased.
Patient Satisfaction
Patient Satisfaction Questionnaire. Questions are on a scale of -3 to 3, with -3 meaning the condition greatly decreased, and 3 meaning the condition greatly increased.
Dermatology Quality of Life Survey Baseline
Dermatology Life Quality Index. This is a standardized dermatology scale. Questions are subjectively answered by participants with answer choices ranging from "very much, a lot, a little, and not at all."
Dermatology Quality of Life Survey
Dermatology Life Quality Index. This is a standardized dermatology scale. Questions are subjectively answered by participants with answer choices ranging from "very much, a lot, a little, and not at all."
Dermatology Quality of Life Survey
Dermatology Life Quality Index. This is a standardized dermatology scale. Questions are subjectively answered by participants with answer choices ranging from "very much, a lot, a little, and not at all."
Dermatology Quality of Life Survey
Dermatology Life Quality Index. This is a standardized dermatology scale. Questions are subjectively answered by participants with answer choices ranging from "very much, a lot, a little, and not at all."
Dermatology Quality of Life Survey
Dermatology Life Quality Index. This is a standardized dermatology scale. Questions are subjectively answered by participants with answer choices ranging from "very much, a lot, a little, and not at all."
Secondary Outcome Measures
Full Information
NCT ID
NCT05362929
First Posted
April 18, 2022
Last Updated
October 12, 2023
Sponsor
Albert Einstein College of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT05362929
Brief Title
Efficacy and Tolerability of a Hybrid Fractional Laser for the Treatment of Acne Scars in Patients With Skin of Color
Official Title
Efficacy and Tolerability of a Hybrid Fractional Laser for the Treatment of Acne Scars in Patients With Skin of Color
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 11, 2023 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Albert Einstein College of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The investigators aim to investigate the efficacy and tolerability of a hybrid non-ablative/ablative laser for acne scarring in skin of color.
Detailed Description
Acne is chronic inflammatory condition involving the pilosebaceous unit. One of the most common complications of acne is scarring, which occurs as a result of dermal damage during the healing process of active acne. Studies have shown that acne scarring can have a negative impact on an individual's quality of life and has been described as a risk factor for multiple psychiatric conditions including depression, anxiety, suicide, and poor self-esteem. Unfortunately, treatment of acne scarring, particularly those of the atrophic subtype, prove difficult to treat. A 2016 Cochrane review failed to provide sufficient evidence to support the first-line use of any intervention. Laser technology has been emerging as an effective, non-invasive treatment of acne scarring. Ablative lasers work by delivering energy to the dermal layer of the skin, resulting in thermal injury and stimulation of dermal cells to produce collagen, thus resolving the scar. More recently, fractional lasers, which create multiple tiny columns of thermal injury, have been introduced with the benefit of reduced downtime and adverse effects compared to ablative lasers. The fractional CO2 laser is widely used for the treatment of acne scarring, however its use is limited in patients of Fitzpatrick IV and V skin due to risk of hyperpigmentation among other adverse events. The erbium-YAG fractional laser serves as an alternative, and has shown to produce less thermal injury and thus be more well-tolerated with lower risk of adverse effects in patients. The hybrid fractional laser combines a 2940 nm wavelength with a 1470 wavelength and has an ablative component targeting the epidermis and a nonablative component targeting the dermis at the same spot. The investigators seek to investigate the Sciton Halo, hybrid fractional laser for its efficacy in treating acne scarring and tolerability in patients with a specific emphasis on those with Fitzpatrick IV and V skin.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Scars - Mixed Atrophic and Hypertrophic, Hyperpigmentation, Laser-Induced Hyperpigmentation
Keywords
skin of color, fitzpatrick skin type III, fitzpatrick skin type IV, fitzpatrick skin type V, acne scarring, sciton
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a single-institution, baseline-controlled, prospective comparative study
Masking
None (Open Label)
Masking Description
Images of deidentified participants before and after treatment will be presented by two independent, non biased, blinded, board certified dermatologists for rating of improvement and outcome scores.
Allocation
Non-Randomized
Enrollment
46 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hybrid Fractional laser - SOC
Arm Type
Experimental
Arm Description
23 participants with fitzpatrick skin type IV-V will be in this arm. At the first visit, participants will undergo informed consent, education about the procedure, education about proper sun-care, and will be provided sunscreen. Participants will be prescribed a prescription of hydroquinone or a retinol to prevent hyperpigmentation, per standard of care. If participants choose to take this they will wait one month of taking the prescription and then begin treatment sessions. If not, participants can begin treatment sessions right away. Treatment consists of 3 laser sessions with the Sciton Halo hybrid fractional laser. Session amount depends on the degree of improvement. At each session before and after images will be collected. At each session participants will fill out the dermatology quality of life survey as well as a patient satisfaction survey.
Arm Title
Hybrid Fractional laser- Non- SOC
Arm Type
Experimental
Arm Description
23 participants with Fitzpatrick skin type I-III will be in this arm. At the first visit, participants will undergo informed consent, education about the procedure, education about proper sun-care, and will be provided sunscreen. Participants will be prescribed a prescription of hydroquinone or a retinol to prevent hyperpigmentation, per standard of care. If participants choose to take this they will wait one month of taking the prescription and then begin treatment sessions. If not, participants can begin treatment sessions right away. Treatment consists of 3 laser sessions with the Sciton Halo hybrid fractional laser. Session amount depends on the degree of improvement. At each session before and after images will be collected. At each session participants will fill out the dermatology quality of life survey as well as a patient satisfaction survey.
Intervention Type
Device
Intervention Name(s)
Sciton Halo
Other Intervention Name(s)
Sciton hybrid fractional laser, hybrid fractional laser, Serial number: 88086862
Intervention Description
Laser treatment
Primary Outcome Measure Information:
Title
Change from baseline acne scar severity
Description
2 Independent unbiased blinded dermatologists will rate before and after treatment images using Global Scale for Acne Scarring. This scale is rated on a scale of 0 to 5. 0 is the least severe, and 5 is the most severe.
Time Frame
month 3
Title
Change from baseline acne scar severity
Description
2 Independent unbiased blinded dermatologists will rate before and after treatment images using Global Scale for Acne Scarring. This scale is rated on a scale of 0 to 5. 0 is the least severe, and 5 is the most severe.
Time Frame
month 5
Title
Change from baseline acne scar severity
Description
2 Independent unbiased blinded dermatologists will rate before and after treatment images using Global Scale for Acne Scarring. This scale is rated on a scale of 0 to 5. 0 is the least severe, and 5 is the most severe.
Time Frame
month 8
Title
Baseline Patient Satisfaction
Description
Patient Satisfaction Questionnaire. Questions are on a scale of -3 to 3, with -3 meaning the condition greatly decreased, and 3 meaning the condition greatly increased.
Time Frame
month 0 (patient consultation visit )
Title
Patient Satisfaction
Description
Patient Satisfaction Questionnaire. Questions are on a scale of -3 to 3, with -3 meaning the condition greatly decreased, and 3 meaning the condition greatly increased.
Time Frame
throughout study completion, an average of 8 months
Title
Patient Satisfaction
Description
Patient Satisfaction Questionnaire. Questions are on a scale of -3 to 3, with -3 meaning the condition greatly decreased, and 3 meaning the condition greatly increased.
Time Frame
month 3
Title
Patient Satisfaction
Description
Patient Satisfaction Questionnaire. Questions are on a scale of -3 to 3, with -3 meaning the condition greatly decreased, and 3 meaning the condition greatly increased.
Time Frame
month 5
Title
Patient Satisfaction
Description
Patient Satisfaction Questionnaire. Questions are on a scale of -3 to 3, with -3 meaning the condition greatly decreased, and 3 meaning the condition greatly increased.
Time Frame
month 8
Title
Dermatology Quality of Life Survey Baseline
Description
Dermatology Life Quality Index. This is a standardized dermatology scale. Questions are subjectively answered by participants with answer choices ranging from "very much, a lot, a little, and not at all."
Time Frame
month 0 (patient consultation visit)
Title
Dermatology Quality of Life Survey
Description
Dermatology Life Quality Index. This is a standardized dermatology scale. Questions are subjectively answered by participants with answer choices ranging from "very much, a lot, a little, and not at all."
Time Frame
throughout study completion, an average of 8 months
Title
Dermatology Quality of Life Survey
Description
Dermatology Life Quality Index. This is a standardized dermatology scale. Questions are subjectively answered by participants with answer choices ranging from "very much, a lot, a little, and not at all."
Time Frame
month 3
Title
Dermatology Quality of Life Survey
Description
Dermatology Life Quality Index. This is a standardized dermatology scale. Questions are subjectively answered by participants with answer choices ranging from "very much, a lot, a little, and not at all."
Time Frame
month 5
Title
Dermatology Quality of Life Survey
Description
Dermatology Life Quality Index. This is a standardized dermatology scale. Questions are subjectively answered by participants with answer choices ranging from "very much, a lot, a little, and not at all."
Time Frame
month 8
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, seeking treatment for acne scarring
Subject must voluntarily sign and date an IRB approved informed consent form
Subjects with diagnosis of acne scarring recorded over the past 6 months
Able to read, understand and voluntarily provide written informed consent.
Subject is determined to be healthy, non-smoker
Subjects able and willing to comply with the treatment protocol and follow-up schedule and requirements.
Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
Exclusion Criteria:
Subjects does not have the capacity to consent to the study
subject underwent any acne scar treatments in the past 6 months prior to enrollment in the study
Subject has active papulopustular or cystic acne within the past 6 months.
Any history of keloidal 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.
History or current use of the following prescription medications:
Immunosuppressive medications/biologics, 6 months prior to and during the study
Accutane or other systemic retinoids within the past twelve months
Smoking or vaping in the past 12 months.
History of photosensitivity and/or connective tissue disease
History of hyperlipidemia, diabetes mellitus, hepatitis, or bleeding disorders.
History of major depressive disorders or endocrine disorders including but not limited to; hypothyroidism, Hashimoto's thyroiditis, or hyperthyroidism.
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
Eden Axler, BS
Phone
4048490867
Email
edenaxler@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kseniya Kobets, MD
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
555 Taxter Road
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
Phone
518-596-4306
Email
hailey.konisky@einsteinmed.edu
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No individual participant data will not be available to researchers not part of the original research team. All patient data will be de-identified.
Learn more about this trial
Efficacy and Tolerability of a Hybrid Fractional Laser for the Treatment of Acne Scars in Patients With Skin of Color
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