RECRUITING

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

Conditions

Acne Scars - Mixed Atrophic and Hypertrophic Hyperpigmentation Laser-Induced Hyperpigmentation skin of color fitzpatrick skin type III fitzpatrick skin type IV fitzpatrick skin type V acne scarring sciton

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2023-10-11

Study Completion:2025-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05362929

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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: * 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

Inclusion Criteria

Exclusion 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.

* 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:
* 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

Contacts and Locations

Study Contact

Janet Choi, BS

CONTACT

(917)680-9907

janet.choi@einsteinmed.edu

Principal Investigator

Kseniya Kobets, MD

PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Study Locations (Sites)

555 Taxter Road

Elmsford, New York, 10523

United States

Collaborators and Investigators

Sponsor: Albert Einstein College of Medicine

Kseniya Kobets, MD, PRINCIPAL_INVESTIGATOR, Montefiore Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-11

Study Completion Date2025-09

Study Record Updates

Study Start Date2023-10-11

Study Completion Date2025-09

Terms related to this study

Keywords Provided by Researchers

skin of color
fitzpatrick skin type III
fitzpatrick skin type IV
fitzpatrick skin type V
acne scarring
sciton

Additional Relevant MeSH Terms

Acne Scars - Mixed Atrophic and Hypertrophic
Hyperpigmentation
Laser-Induced Hyperpigmentation