RECRUITING

A Comparative Clinical Study to Assess Pain Score and Wound Healing Following Fractional Ablation With a DFG Laser and CO2 Laser

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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

This research study aims assess whether the Difference Frequency Generation (DFG) laser could be a better alternative to the CO2 laser in terms of reduced side effects and patient downtime.

Official Title

A Comparative Clinical Study to Assess Pain Score and Wound Healing Following Fractional Ablation With a Difference Frequency Generation (DFG) Laser and Carbon Dioxide (CO2) Laser

Quick Facts

Study Start:2024-10-16

Study Completion:2025-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06295471

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
* Subjects must be able and willing to provide written informed consent and comply with the requirements of the study protocol; * Subjects must be in good general health, based on answers provided during the screening visit; * Subjects must be able to read and understand English. * Subjects must be above the age of 18. * Subjects must have no history of skin conditions that affect the integrity of the skin barrier.	* Are pregnant or lactating; * Have a history of drug or alcohol abuse or have reported habitual alcohol intake greater than 2 standard drinks per day \[e.g., 2 beers, 2 glasses of wine, or 2 mixed drinks\]; * Are smoking or have a history of smoking; * Presence of eczema, psoriasis, skin wounds or ulcers, or any other skin disease on the thighs; * Have birth marks, tattoos, scars, or any other disfiguration of the skin in the skin area of interest; * Presence of sunburn or tan in the treatment area; * Use of any topical application of retinoids in the area of interest or systemic retinoids in the past 6 months; * Use of any prescription topical medication, such as corticosteroids or hydroquinone on the skin area of interest in the past 6 months; * History of blood-clotting abnormality; * History of keloid formation or hypertrophic scarring; * History of allergic reaction to local anesthesia, aluminum chloride, and/or glycerol; * Investigator, interfere with study evaluations or pose a risk to subject safety during the study; * Exhibits any clinical conditions or takes any medication which in the opinion of the investigator may interfere with the study or pose a risk to subject safety during the study; * Is not able to follow study protocol.

Inclusion Criteria

Exclusion Criteria

* Subjects must be able and willing to provide written informed consent and comply with the requirements of the study protocol;
* Subjects must be in good general health, based on answers provided during the screening visit;
* Subjects must be able to read and understand English.
* Subjects must be above the age of 18.
* Subjects must have no history of skin conditions that affect the integrity of the skin barrier.

* Are pregnant or lactating;
* Have a history of drug or alcohol abuse or have reported habitual alcohol intake greater than 2 standard drinks per day \[e.g., 2 beers, 2 glasses of wine, or 2 mixed drinks\];
* Are smoking or have a history of smoking;
* Presence of eczema, psoriasis, skin wounds or ulcers, or any other skin disease on the thighs;
* Have birth marks, tattoos, scars, or any other disfiguration of the skin in the skin area of interest;
* Presence of sunburn or tan in the treatment area;
* Use of any topical application of retinoids in the area of interest or systemic retinoids in the past 6 months;
* Use of any prescription topical medication, such as corticosteroids or hydroquinone on the skin area of interest in the past 6 months;
* History of blood-clotting abnormality;
* History of keloid formation or hypertrophic scarring;
* History of allergic reaction to local anesthesia, aluminum chloride, and/or glycerol;
* Investigator, interfere with study evaluations or pose a risk to subject safety during the study;
* Exhibits any clinical conditions or takes any medication which in the opinion of the investigator may interfere with the study or pose a risk to subject safety during the study;
* Is not able to follow study protocol.

Contacts and Locations

Study Contact

Alicia Van Cott, MSN

CONTACT

617-726-4454

avancott@mgb.org

Abigail Carlson, BS

CONTACT

617-726-4454

acarlson9@mgh.harvard.edu

Principal Investigator

Dieter Manstein, MD, PhD

PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Study Locations (Sites)

MGH Clinical Unit for Research Trials & Outcomes in Skin

Boston, Massachusetts, 02114

United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

Dieter Manstein, MD, PhD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

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 Date2024-10-16

Study Completion Date2025-06

Study Record Updates

Study Start Date2024-10-16

Study Completion Date2025-06

Terms related to this study

Keywords Provided by Researchers

Laser

Additional Relevant MeSH Terms

Healthy