Efficacy and Tolerability of a Hybrid Fractional Laser for the Treatment of Acne Scars in Patients With Skin of Color

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The investigators aim to investigate the efficacy and tolerability of a hybrid non-ablative/ablative laser for acne scarring in skin of color.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
United States
New York
555 Taxter Road
RECRUITING
Elmsford
Contact Information
Primary
Anika Jallorina, BS
ajallorina@montefiore.org
618-704-8716
Time Frame
Start Date: 2023-10-11
Estimated Completion Date: 2026-09
Participants
Target number of participants: 46
Treatments
Experimental: Hybrid Fractional laser - SOC
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.
Experimental: Hybrid Fractional laser- Non- SOC
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.
Related Therapeutic Areas
Sponsors
Leads: Albert Einstein College of Medicine

This content was sourced from clinicaltrials.gov