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Nonablative Laser

Laser Therapy for Male Pattern Baldness and Scarring Alopecia

N/A

Recruiting

Led By Kseniya Kobets, MD

Research Sponsored by Montefiore Medical Center

Eligibility Criteria Checklist

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

Must have

Subjects with diagnosis of biopsy proven androgenetic alopecia or scarring alopecia with hair loss recorded over the past 6 months

Be older than 18 years old

Must not have

History or current use of immunosuppressive medications/biologics, 6 months prior to and during the study

Any previous surgical procedure in the treatment area in the past 12 months, or major surgery in the last 6 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 15

Awards & highlights

No Placebo-Only Group

Summary

This trialtested a laser to treat two types of hair loss: androgenetic & scarring alopecia.

Who is the study for?

This trial is for healthy adults over 18 with a confirmed diagnosis of androgenetic alopecia or scarring alopecia, who have experienced hair loss in the last 6 months. Participants must not smoke, should agree to maintain their current hair care routine without changes, and cannot have used certain hair loss treatments recently.

What is being tested?

The study tests a non-ablative 1470 nm laser (Sciton HALO) on individuals with specific types of hair loss. It's an open-label pilot study where all participants receive the same treatment to see if it improves their condition.

What are the potential side effects?

While specific side effects are not listed here, similar laser treatments may cause skin irritation, redness, swelling at the treatment site, and potential changes in skin pigmentation.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with a type of hair loss due to genetics or 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 haven't taken immunosuppressive drugs in the last 6 months.

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

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I have a history of high cholesterol, diabetes, hepatitis, or bleeding disorders.

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I have a type of hair loss condition affecting my scalp.

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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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 15

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 15

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 15 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Hair counts

Hair density

Live and Photographic assessment of hair loss

Secondary study objectives

Subject Satisfaction

Subject Satisfation

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: Scarring AlopeciaExperimental Treatment1 Intervention

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 scarring alopecia.

Group II: Androgenetic AlopeciaExperimental Treatment1 Intervention

0 / 7Eligibility criteria met