ACTIVE_NOT_RECRUITING

Investigation of Laser Assisted Drug Delivery of NanoDOX®

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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 is a self-controlled single-site study of healthy subjects receiving an ablative fractional CO2 (carbon dioxide) laser procedure followed by topical application of NanoDOX® Hydrogel (1% doxycycline). The study includes skin biopsies to evaluate the effects of NanoDOX® Doxycycline Monohydrate Gel on wound healing after the ablative laser procedure. Study subjects will be asked to do 2 visits of 4 hours in total over approximately 1 week. An optional third visit will take place approximately 6 weeks after Visit 1. In this study, 20 subjects are expected to enroll with a goal of 12 healthy subjects to enroll and complete the study.

Official Title

Self-controlled, Single-site Trial Investigation of Laser Assisted Drug Delivery of NanoDOX®

Quick Facts

Study Start:2023-11-29

Study Completion:2025-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05411484

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 to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Subject must be able and willing to provide written informed consent and comply with the requirements of the study protocol; * Subject must be able to read and understand English; * Any gender and any Fitzpatrick skin type; * Age equal to or greater than 18 years old; * Willing to sun protect treated area (sunscreen or cover the area with clothes) for the duration of enrollment in the study and 1 year after treatment. * Subjects must be willing to undergo skin biopsies	* Participation in another investigational drug or device clinical trial in the past 30 days; * Are pregnant or lactating; * History of allergic reaction to topical or local anesthesia; * History of allergic reaction to Doxycycline or other tetracyclines; * Regular intake of high doses of anti-inflammatory drugs (aspirin \>81 mg/day, ibuprofen, corticosteroids, etc.) , immunosuppressive drugs or biologics; * Clinically significant abnormal findings or conditions which might, in the opinion of the Investigator, interfere with study evaluations or pose a risk to subject safety during the study; * Laser treatment in past six months; History of poor wound healing; * History of keloids; History of extreme photosensitivity; * History of severe hyperpigmentation; History of tattoos on thighs.

Inclusion Criteria

Exclusion Criteria

* Subject must be able and willing to provide written informed consent and comply with the requirements of the study protocol;
* Subject must be able to read and understand English;
* Any gender and any Fitzpatrick skin type;
* Age equal to or greater than 18 years old;
* Willing to sun protect treated area (sunscreen or cover the area with clothes) for the duration of enrollment in the study and 1 year after treatment.
* Subjects must be willing to undergo skin biopsies

* Participation in another investigational drug or device clinical trial in the past 30 days;
* Are pregnant or lactating;
* History of allergic reaction to topical or local anesthesia;
* History of allergic reaction to Doxycycline or other tetracyclines;
* Regular intake of high doses of anti-inflammatory drugs (aspirin \>81 mg/day, ibuprofen, corticosteroids, etc.) , immunosuppressive drugs or biologics;
* Clinically significant abnormal findings or conditions which might, in the opinion of the Investigator, interfere with study evaluations or pose a risk to subject safety during the study;
* Laser treatment in past six months; History of poor wound healing;
* History of keloids; History of extreme photosensitivity;
* History of severe hyperpigmentation; History of tattoos on thighs.

Contacts and Locations

Principal Investigator

Dieter Manstein, MD, PhD

PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Study Locations (Sites)

MGH Clinical Unit for Research Trials And Outcome

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 Date2023-11-29

Study Completion Date2025-02

Study Record Updates

Study Start Date2023-11-29

Study Completion Date2025-02

Terms related to this study

Keywords Provided by Researchers

WOUND
DRUG-DELIVERY

Additional Relevant MeSH Terms

Wounds and Injury