Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID05362929

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

Led by Albert Einstein College of Medicine ยท Updated on 2025-05-22

46

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a hybrid fractional laser to treat acne scars, especially in patients with darker skin tones (Fitzpatrick IV and V). Acne scarring, often caused by skin damage during healing, can negatively affect quality of life and mental health. Current treatments struggle with effectiveness and safety in skin of color, prompting this study to focus on a hybrid laser combining ablative and non-ablative components. The study involves two groups based on skin type: one with Fitzpatrick IV-V and another with Fitzpatrick I-III. Each participant receives up to three sessions of the Sciton Halo hybrid fractional laser, which uses two wavelengths to target different skin layers. Before treatment, participants receive education on the procedure and sun care, and may be prescribed hydroquinone or retinol to reduce the risk of hyperpigmentation. Treatment sessions include before and after photos, and participants complete surveys on quality of life and satisfaction. Participants will be involved for about eight months, with assessments at multiple points including baseline, 3, 5, and 8 months. These assessments measure changes in acne scar severity, patient satisfaction, and dermatology quality of life using standardized surveys. The study monitors tolerability and outcomes throughout, ensuring participants follow the treatment and follow-up schedule. The research aims to improve understanding of hybrid laser treatment effects in skin of color.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy males and females 18 years of age or older
  • Seeking treatment for acne scarring
  • Diagnosis of acne scarring recorded within the past 6 months
  • Able to read, understand, and voluntarily provide written informed consent
  • Healthy non-smoker
  • Able and willing to comply with treatment protocol and follow-up schedule
  • Agrees not to undergo other procedures in the treatment areas during follow-up period
Not Eligible

You will not qualify if you...

  • Unable to provide informed consent
  • Acne scar treatments within 6 months prior to enrollment
  • Active papulopustular or cystic acne within past 6 months
  • History of keloidal scarring
  • Surgical procedures in the treatment area within past 12 months or major surgery in past 6 months
  • History of immunosuppression, immune deficiency, or systemic chemotherapy in past 12 months
  • Use of immunosuppressive medications or biologics within 6 months prior to and during study
  • Use of Accutane or systemic retinoids in past 12 months
  • Smoking or vaping in past 12 months
  • History of photosensitivity or connective tissue disease
  • History of hyperlipidemia, diabetes, hepatitis, or bleeding disorders
  • History of major depressive or endocrine disorders including hypothyroidism, Hashimoto's thyroiditis, or hyperthyroidism
  • Current pregnancy, active breastfeeding, cancer, or epilepsy

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Run-in Period

Duration - 1 month

Participants prescribed hydroquinone or retinol wait one month before beginning treatment.

1 visit (in-person) for prescription and education

Treatment

Duration - Variable, depending on degree of improvement

Participants receive up to 3 sessions of hybrid fractional laser treatment with Sciton Halo. Before and after images are taken and surveys on quality of life and satisfaction are completed at each session.

3 treatment visits (in-person)

Follow-up

Duration - Up to 8 months after baseline

Participants complete surveys on acne scar severity, quality of life, and satisfaction through approximately 8 months after baseline.

Visits at months 3, 5, and 8 for assessments

Trial Site Locations

Total: 1 location

1

555 Taxter Road

Elmsford, New York, United States, 10523

Actively Recruiting

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Research Team

A

Anika Jallorina, BS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

2

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