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Laser Therapy

Hybrid Fractional Laser for Acne Scars

N/A

Recruiting

Led By Kseniya Kobets, MD

Research Sponsored by Albert Einstein College of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Healthy males and females, ≥ 18 years of age at time of informed consent, seeking treatment for acne scarring

Subjects with diagnosis of acne scarring recorded over the past 6 months

Must not have

Subjects does not have the capacity to consent to the study

History of immunosuppression/immune deficiency disorders (including AIDS and HIV infection), and/or any history of systemic chemotherapy for prior 12 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 8

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at how well a laser treatment works to reduce acne scars on skin of color.

Who is the study for?

This trial is for adults over 18 with a history of acne scarring who are seeking treatment. Participants must be healthy, non-smokers, and able to follow the study's procedures. They cannot have had any facial surgery in the past year or acne scar treatments in the last six months, nor should they have certain health conditions like major depression, endocrine disorders, or a tendency to form keloid scars.

What is being tested?

The Sciton Halo laser is being tested for its effectiveness on treating acne scars specifically in people with skin of color. The study will assess how well it works and how tolerable it is for participants.

What are the potential side effects?

Potential side effects may include temporary redness, swelling at the treatment site, changes in skin pigmentation such as lightening or darkening of treated areas (hyperpigmentation), and possibly some discomfort during the procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am over 18 and want treatment for my acne scars.

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I have been diagnosed with acne scarring in the last 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am unable to give consent for the study on my own.

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I have not had chemotherapy in the last 12 months and do not have an immune deficiency.

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I am not pregnant, breastfeeding, and do not have cancer or epilepsy.

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I have a history of being unusually sensitive to sunlight or have a connective tissue disease.

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I have had severe acne in the last 6 months.

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I haven't taken immunosuppressants or retinoids in the past 6-12 months.

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I haven't had surgery in the treatment area in the past year or any major surgery in the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 8

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 8

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 8 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Baseline Patient Satisfaction

Cicatrization

Dermatology Quality of Life Survey

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Hybrid Fractional laser- Non- SOCExperimental Treatment1 Intervention

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.

Group II: Hybrid Fractional laser - SOCExperimental Treatment1 Intervention

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.

0 / 9Eligibility criteria met